DolceraWiki - User contributions [en]

File:Pathway products pipeline.jpg

2007-10-24T08:28:34Z

Rajiv:

Osteoporosis

2007-10-24T08:22:00Z

Rajiv: /* Pathways */

Osteoporosis is a systematic skeletal disease characterized by low bone mass, increase of bone fragility and susceptibility to fracture.

'''Types of Osteoporosis and its causes'''
#'''Primary osteoporosis(Type I (postmenopausal) or Type II (senile) )''':
##''Type I (postmenopausal)'': Generally develops in women after menopause when the amount of estrogen in the body greatly decreases. This process leads to an increase in the resorption of bone (the bones loses substance).
##''Type II (senile)'': This involves a thinning of both the trabecular bone (the spongy bone inside of the hard cortical bone) and the hard cortical bone. This process often leads to hip and vertebral body (in the spine) fractures.
#'''Secondary osteoporosis''': Secondary osteoporosis has the same symptoms as primary osteoporosis. However, it occurs as a result of having certain medical conditions, such as hyperthyroidism or leukemia. It may also occur as a result of taking medications known to cause bone breakdown, such as oral or high-dose inhaled corticosteroids (if used for more than 6 months), too high a dose of thyroid replacement, or aromatase inhibitors (used to treat breast cancer).
#'''Osteogenesis imperfecta''': Osteogenesis imperfecta is a rare form of osteoporosis that is present at birth. Osteogenesis imperfecta causes bones to break for no apparent reason.
#'''Idiopathic juvenile osteoporosis''':Idiopathic juvenile osteoporosis is rare. It occurs in children between the ages of 8 and 14 or during times of rapid growth. There is no known cause for this type of osteoporosis, in which there is too little bone formation or excessive bone loss.

==Incidence and prevalence==
[[Image:Osteoporosis incidence.jpg|thumb|center|500px]]
===Incidence===
* 1 in 3 women over 50 will suffer a fracture due to osteoporosis; this increases to 1 in 2 over 60.
* 1 in 5 men over 50 will suffer a fracture due to osteoporosis; this increases to 1 in 3 over 60.
* Approximately 1.6 million hip fractures occur each year worldwide, the incidence is set to increase to 6.3 million by 2050.
* The highest risk of hip fractures are seen in Norway, Sweden, Iceland, Denmark and the USA.
* Currently, there is an increasing incidence of hip fractures in the developed cities in Asia. 1 out of 4 hip fractures occur in Asia and Latin America. This number of hip fractures will increase to 1 in 2 by 2050.
* In the Middle East, the burden of osteoporosis in the general population is expected to increase and is becoming a heavy financial burden.7
* The annual incidence rate of osteoporotic fractures in women is greater than the combined incidence rates of heart attack, stroke and breast cancer. ([[Media:Osteoporosis_factsheet.pdf|International osteoporosis foundation]])

===Prevalence===
*28 million Americans (10 million with osteoporosis; 18 million with low bone mass); eight million American women and 2 million men (NWHIC)(approx 1 in 9 or 10.29% or 28 million people in USA ).
*Total prevalence rate of osteoporosis in the middle- aged and elderly in China was 16. 1% in 2002. The prevalence rate among males was 11. 5% and among females was 19. 9%.
*Prevalence increase to 2.2 million in 2006 and 3 million in 2021 in Australia.
*The prevalence of Khon Kaen (Thai rural area) women has osteporosis in femoral neck and lumbar spine is 19.3% and 24.7% respectively. ([[Media:Osteoporosis_factsheet.pdf|International osteoporosis foundation]])

{|border="2" cellspacing="0" cellpadding="4" width="100%"
|align = "center" bgcolor = "#FFFF99"|'''S.NO'''
|bgcolor = "#FFFF99"|'''Country/Region'''
|bgcolor = "#FFFF99"|'''Extrapolated Prevalence'''
|-
|align = "center"|1
|USA
|10 million cases (80% cases are women and 20% cases are men)
|-
|align = "center"|2
|Australia
|2.2 million
|-
|align = "center"|3
|Middle east
|18,603,593
|-
|align = "center"|4
|Africa
|47,233,590
|-
|align = "center"|5
|Asia
|359,862,754
|-
|align = "center"|6
|Europe
|80,590,570
|-
|}

==Product Information==
[[Image:osteoporosis.jpg|800 px|center|thumb| Overall categorization of osteoporosis treatments]]
===Products in market===

{|border="2" cellspacing="0" cellpadding="4" width="100%"
|bgcolor = "#FFFF99"|'''Generic'''
|bgcolor = "#FFFF99"|'''Brand'''
|bgcolor = "#FFFF99"|'''Current Status'''
|bgcolor = "#FFFF99"|'''Type'''
|bgcolor = "#FFFF99"|'''Company'''
|-
|bgcolor = "#CCFFCC" colspan = "5"|'''Antiresorptives'''
|-
|align = "center" colspan = "5"|'''Bisphosphonates'''
|-
|Alendronate
|FOSAMAX®
|Approved by US
|Postmenopausal
|[http://www.merck.com/product/ Merck]
|-
|Risedronate
|Actonel®
|Approved by US/ES
|Postmenopausal
|[http://en.sanofi-aventis.com/ Sanofi-Aventis/Procter & Gamble]
|-
|Ibandronate
|Boniva™
|Approved by US
|Postmenopausal
|[http://www.roche.com/home.html Roche]
|-
|Etidronate
|Didronel
|Off Label
| 
|[http://www.pgpharma.com/consumer_didronel.shtml Proctor And Gamble]
|-
|Zoledronic Acid
|Aclasta
|Approved
|Postmenopausal
|[http://www.medicalnewstoday.com/articles/80208.php Novartis]
|-
|align = "center" colspan = "5"|'''Selective Estrogen Receptor Modulators'''
|-
|Raloxifene
|Evista®
|Approved by US
|Osteoporosis
|[http://www.lilly.com/ Eli lilly]
|-
|align = "center" colspan = "5"|'''Hormone Replacement Therapy'''
|-
|Conjugated estrogen
|Premarin®
|Approved by US
|Postmenopausal
|[http://www.wyeth.com/ Wyeth]
|-
|Conjugated estrogen
|Cenestin™
|Approved by US
|Postmenopausal
|[http://www.drugdigest.org/DD/HC/HCDrugClass/0,4055,34-19,00.html Duramed]
|-
|Esterified estrogens
|Estratab®
|Approved by US
|Postmenopausal
|[http://www.solvay.com/ Solvay]
|-
|Esterified estrogens
|Menesta
|Approved by US
|Postmenopausal
|[http://www.google.co.in/url?sa=t&ct=res&cd=1&url=http%3A%2F%2Fwww.monarchpharm.com%2Findex.cgi%3FCONTEXT%3Dpoalph%26BISKIT%3D95434236815619&ei=bfO_Rpz8Io66sgK63ZS5CA&usg=AFQjCNEFn9uNNf941eVdhDU28dKL-77PGA&sig2=TS_t-tguidki-FvhYmkiMA Monarch]
|-
|Estradiol Transdermal System
|Menostar
|Approved by US
|Postmenopausal
|[http://www.menostar-us.com/HCP/index.html Bayer]
|-
|Estradiol Transdermal System
|Vivelle Dot
|Approved by US
|Postmenopausal
|[http://www.noven.com/PR052002.htm Noven]
|-
|Estradiol
|Estrace®
|Approved by US
|Postmenopausal
|[http://www.bms.com/landing/data/index.html Bristol-Myers Squibb]
|-
|Estradiol
|Gynodiol
|Approved by US
|Postmenopausal
|[http://www.novavax.com/ Novavax]
|-
|Tibolone
|Livifem
| 
|Postmenopausal
| 
|-
|align = "center" colspan = "5"|'''Calcitonin'''
|-
|Calcitonin Salmon Injection
|Miacalcin®
|Approved by US
|Postmenopausal
|[http://www.novartis.com/ Novartis]
|-
|Calcitonin Salmon Nasal Spray
|Miacalcin®
|Approved by US
|Postmenopausal
|[http://www.novartis.com/ Novartis]
|-
|Calcitonin Salmon Nasal Spray
|Fortical®
|Approved by US
|Postmenopausal
| 
|-
|bgcolor = "#CCFFCC" colspan = "5"|'''Bone Forming Drugs'''
|-
|Teripratide
|Forteo®
|Approved by US
|Osteoporosis
|[http://www.pfizer.com/home/ Pfizer]
|-
|bgcolor = "#CCFFCC" colspan = "5"|'''Drugs with Complex Mechanisms of Action'''
|-
|Strontium Ranelate
|Protelos
|Not approved in USA
|Postmenopausal osteoporosis
|[http://www.servier.com/pro/osteoporose/home_osteo.asp Servier]
|-
|Vitamin D
| 
| 
| 
| 
|-
|Calcium
| 
|[http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-22573.htm FDA is considering amending rules so that companies can now claim that calcium and Vitamin D in their food supplements can prevent osteoprorosis in all ages and both sexes]
| 
|FDA
|-
|}

===Product pipeline===
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|align = "center" bgcolor = "#FFFF99" colspan = "5" rowspan = "1" |'''Product Pipeline'''
|-
|colspan = "5"|
|-
|align = "center"|'''DRUG'''
|align = "center"|'''COMPANY'''
|align = "center"|'''DESCRIPTION'''
|align = "center"|'''STAGE'''
|-
|colspan = "5"|'''RANKL Inhibitors'''
|-
|align = "center"|Denosumab
|align = "center"|[http://www.alantos.com/investors/pipe.jsp/ Atlantos, Amgen]
|align = "center"|A monoclonal antibody
|align = "center"|3
|align = "center"|
|-
|colspan = "5"|'''Bisphosphonates'''
|-
|align = "center"|Minodronate (YM529)
|align = "center"|Astellas
|align = "center"|Nitrogen containing bisphosphonate
|align = "center"| 
|align = "center"| 
|-
|colspan = "5"|'''Calcium Antagonist'''
|-
|align = "center"|423557
|align = "center"|[http://www.gsk.com/investors/reps04/20F-2004.pdf Glaxosmithkline]
|align = "center"| 
|align = "center"|1
|-
|align = "center"|423562
|align = "center"|[http://www.gsk.com/investors/reps04/20F-2004.pdf Glaxosmithkline]
|align = "center"| 
|align = "center"|1
|-
|align = "center"|Calcilytics (751689)
|align = "center"|[http://www.npsp.com/drug_development/dd_calcilytics.php/ NPS and Glaxosmithkline]
|align = "center"|Calcilytics antagonize calcium receptors on parathyroid glands resulting in a transient release of the body<nowiki>’</nowiki>s own stores of parathyroid hormone (PTH).
|align = "center"|1
|-
|colspan = "5"|'''Parathyroid Hormone'''
|-
|align = "center"|768974
|align = "center"|[http://www.gsk.com/investors/product_pipeline/docs/pipeline.pdf/ Glaxosmithkline]
|align = "center"|Parathyroid Hormone Agonist
|align = "center"|1
|-
|align = "center"|Preos (rDNA origin)
|align = "center"|[http://www.npsp.com/drug_development/dd_calcilytics.php NPS]
|align = "center"|Recombinant Parathyroid Hormone
|align = "center"|Registration Filed
|-
|align = "center"|PTH1-34
|align = "center"|[http://www.nastech.com/nastech/pipeline/ Nastech]
|align = "center"|Intranasal Parathyroid hormone
|align = "center"|2
|align = "center"|
|-
|align = "center"|PTH1-34
|align = "center"|[http://www.emisphere.com/pc_pp.asp Novartis, Emisphere]
|align = "center"|Oral Parathyroid hormone
|align = "center"|1
|align = "center"|
|-
|align = "center"|PTH Analogs
|align = "center"|[http://www.unigene.com/products/product_pipeline.php/ Unigene]
|align = "center"| 
|align = "center"|2
|-
|colspan = "5"|'''Cathepsin k Inhibitor'''
|-
|align = "center"|Relacatib (SB-462795)
|align = "center"|[http://www.gsk.com/investors/product_pipeline/docs/pipeline.pdf/ GlaxoSmithkline]
|align = "center"| 
|align = "center"|1
|-
|align = "center"|AAE581
|align = "center"|[http://www.asbmr.org/news/press_releases/2005/royrelease.cfm Novartis]
|align = "center"| 
|align = "center"| 
|-
|align = "center"|MK-0822
|align = "center"|[http://www.merck.com/finance/annualreport/ar2006/pipeline.html/ Canadian Institutes of Health Research, Merck]
|align = "center"| 
|align = "center"|2
|-
|colspan = "5"|'''Selective Estrogen Receptor Modulators'''
|-
|align = "center"|Bazedoxifene
|align = "center"|[http://clinicaltrials.gov/ct/gui/search?term=bazedoxifene&submit=Search/ Wyeth, Ligand]
|align = "center"|A Third-Generation Selective Estrogen Receptor Modulator for Treatment of Postmenopausal Osteoporosis
|align = "center"| 
|-
|align = "center"|Lasofoxifene (Oporia)
|align = "center"|[http://www.ligand.com/collaborations.php#Leading/ Pfizer,Ligand]
|align = "center"|A Third-Generation Selective Estrogen Receptor Modulator for Treatment of Postmenopausal Osteoporosis
|align = "center"|NDA
|-
|align = "center"|Arzoxifene
|align = "center"|[http://www.lillytrials.com/ Eli lilly]
|align = "center"| 
|align = "center"| 
|-
|align = "center"|Taromifene (Fareston)
|align = "center"|[http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1550783 Orion]
|align = "center"| 
|align = "center"| 
|-
|colspan = "5"|'''Calcitonin'''
|-
|align = "center"| 
|align = "center"|[http://www.nastech.com/nastech/pipeline/ Nastech]
|align = "center"| 
|align = "center"|NDA
|-
|align = "center"|Salmon calcitonin
|align = "center"|[http://www.unigene.com/products/product_pipeline.php/ Unigene]
|align = "center"|Nasal
|align = "center"|3
|-
|align = "center"|Salmon calcitonin
|align = "center"|[http://www.unigene.com/products/product_pipeline.php/ Unigene]
|align = "center"|Oral
|align = "center"|2
|-
|align = "center"|Salmon calcitonin (SMC 021)
|align = "center"|[http://www.emisphere.com/pc_osc.asp Novartis, Emisphere, Nordic]
|align = "center"|Oral
|align = "center"|3
|-
|align = "center"|Salmon calcitonin
|align = "center"|[http://www.sbtdc.org/technology/sbir/nobex.pdf Nobex (Biocon)]
|align = "center"|Oral
|align = "center"|3
|-
|colspan = "5"|'''Vitamin D'''
|-
|align = "center"|ED 71
|align = "center"|[http://www.chugai-pharm.co.jp/english/ir/pipeline/index.html<nowiki> </nowiki>Bone/ Chugai]
|align = "center"|Activted Vitamin D derivative
|align = "center"|3
|-
|align = "center"|Doxercalciferol (Hectorol)
|align = "center"|[http://www.centerwatch.com/patient/drugs/dru614.html Bone Care Int.]
|align = "center"|Synthetic Vitamin D
|align = "center"| 
|-
|colspan = "5"|'''Nitrates: Research is going on to determine if nitrates can prevent osteoporosis in women.'''
|-
|align = "center"|Isosorbide mononitrate
|align = "center"|[http://clinicaltrials.gov/ct/show/ St. Michael<nowiki>’</nowiki>s Hospital, Toronto]
|align = "center"| 
|align = "center"|3
|-
|align = "center"|Nitroglycerine
|align = "center"|[http://clinicaltrials.gov/ct/show/NCT00252421 Canadian Institutes of Health Research (CIHR)]
|align = "center"| 
|align = "center"|3
|-
|align = "center"|HCT 1026 (NO releasing Derivative of NSAIDs)
|align = "center"|[http://www.centerwatch.com/bookstore/nmt/nmtb_osteoporosis.pdf NicOx SA]
|align = "center"| 
|align = "center"|2
|align = "center"| 
|-
|colspan = "5"|'''Selective Androgen Receptor Modulator (SARM)'''
|-
|align = "center"|LGD-2941
|align = "center"|[http://investors.ligand.com/releasedetail.cfm?ReleaseID=258992 Ligand, TAP]
|align = "center"| 
|align = "center"|3
|-
|align = "center"|LGD-3303
|align = "center"|[http://www.ligand.com/research.php Ligand, TAP]
|align = "center"| 
|align = "center"|3
|-
|align = "center"|Ostarine
|align = "center"|[http://www.gtxinc.com/tech/pipeline.htm GTx]
|align = "center"| 
|align = "center"|2
|-
|align = "center"|Intermittent Versus Continuous Androgen Suppression
|align = "center"|[http://clinicaltrials.gov/ct/show/NCT00228124?order=111/ Ontario Cancer Research Network]
|align = "center"| 
|align = "center"| 
|-
|align = "center" bgcolor = "#FFFF99" colspan = "5"|
|-
|align = "center"|Mk 0733
|align = "center"|[http://www.merck.com/finance/annualreport/ar2006/pipeline.html Merck]
|align = "center"| 
|align = "center"|1
|-
|align = "center"|TH0229
|align = "center"|Theratechnologies
|align = "center"| 
|align = "center"| 
|align = "center"| 
|-
|align = "center"|c-8500
|align = "center"|Merck
|align = "center"| 
|align = "center"|2
|align = "center"| 
|-
|align = "center"|c-3578
|align = "center"|Merck
|align = "center"| 
|align = "center"|2
|align = "center"| 
|-
|align = "center"|apomorphine
|align = "center"|Ilex Oncology
|align = "center"| 
|align = "center"|2
|align = "center"| 
|-
|align = "center"|Genistein
|align = "center"|[http://www.newsrx.com/newsletters/Drug-Law-Weekly/2007-07-10/2207102007866DL.html<nowiki> </nowiki> Primus Pharmaceuticals, Inc.] 
|align = "center"|isoflavones have been shown to interact with animal and human estrogen receptors, causing effects in the body similar to those caused by the hormone estrogen.
|align = "center"|Available
|-
|align = "center"|Soy estrogens
|align = "center"|[http://clinicaltrials.gov/ct/gui/show/NCT00076050?order=61/ (NIAMS)]
|align = "center"| 
|align = "center"|3
|-
|align = "center"|Hesperidin
|align = "center"|[http://clinicaltrials.gov/ct/gui/show/NCT00330096?order=51/ Nestle clinical nutrition]
|align = "center"| 
|align = "center"|3
|-
|align = "center"|Davallia Divaricata
|align = "center"|[http://clinicaltrials.gov/ct/gui/show/NCT00154609?order=63/ National Taiwan University Hospital]
|align = "center"| 
|align = "center"|1
|-
|align = "center"|Atorvaststin
|align = "center"| [http://clinicaltrials.gov/ct/gui/show/NCT00120133?order=9}]
|align = "center"| 
|-
|align = "center"|Potassium citrate
|align = "center"|[http://clinicaltrials.gov/ct/gui/show/NCT00357331?order=56/ Weill Medical College of Cornell University]
|align = "center"| 
|align = "center"|4
|-
|align = "center"|Phosphorus
|align = "center"|[http://clinicaltrials.gov/ct/gui/show/NCT00074711?order=60/ National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)]
|align = "center"| 
|align = "center"|3
|-
|}

===Devices===
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|[http://www.hiprotector.com/wkit.html Hip Protector]
|Hip pads with special underwear with pockets
| 
|Children<nowiki>’</nowiki>s Mercy Hospital Kansas City
| 
|-
|}

===Pathways===

[[Image:pathway_products.jpg|800 px|center|thumb| PRODUCT PATHWAY]]

[[Image:pathway_products_pipeline.jpg|800 px|center|thumb| PRODUCT PIPELINE]]

==Market Information==
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|align = "center" bgcolor = "#FFFF99" colspan = "10"|Prescription Trends in USA
|-
|align = "center" colspan = "10"|Source: Arch Intern Med. 2004;164:1525-1530
|-
|align = "center"| 
|align = "center"|'''1988'''
|align = "center"|'''1990'''
|align = "center"|'''1992'''
|align = "center"|'''1994'''
|align = "center"|'''1996'''
|align = "center"|'''1998'''
|align = "center"|'''2000'''
|align = "center"|'''2002'''
|align = "center"|'''2003'''
|-
|align = "center"|'''Patients (Millions)'''
|align = "center"|NA
|align = "center"|0.6
|align = "center"|0.6
|align = "center"|0.5
|align = "center"|1.2
|align = "center"|2
|align = "center"|2.6
|align = "center"|2.8
|align = "center"|3.6
|-
|align = "center" colspan = "10"|'''Drugs Prescribed %'''
|-
|align = "center"|'''Bisphosphonates (total)'''
|align = "center"|1
|align = "center"|9
|align = "center"|17
|align = "center"|14
|align = "center"|48
|align = "center"|49
|align = "center"|54
|align = "center"|71
|align = "center"|73
|-
|align = "center"|Alendronate
|align = "center"|0
|align = "center"|0
|align = "center"|0
|align = "center"|0
|align = "center"|45
|align = "center"|47
|align = "center"|48
|align = "center"|53
|align = "center"|51
|-
|align = "center"|Risedronate
|align = "center"|0
|align = "center"|0
|align = "center"|0
|align = "center"|0
|align = "center"|0
|align = "center"|0
|align = "center"|4
|align = "center"|17
|align = "center"|22
|-
|align = "center"|Etidronate
|align = "center"|1
|align = "center"|9
|align = "center"|17
|align = "center"|14
|align = "center"|3
|align = "center"|1
|align = "center"|1
|align = "center"|0
|align = "center"|0
|-
|align = "center"|'''Calcium'''
|align = "center"|39
|align = "center"|33
|align = "center"|33
|align = "center"|43
|align = "center"|31
|align = "center"|26
|align = "center"|29
|align = "center"|26
|align = "center"|24
|-
|align = "center"|'''Calcitonins'''
|align = "center"|5
|align = "center"|9
|align = "center"|10
|align = "center"|13
|align = "center"|13
|align = "center"|16
|align = "center"|15
|align = "center"|7
|align = "center"|5
|-
|align = "center"|'''Estrogens'''
|align = "center"|35
|align = "center"|25
|align = "center"|33
|align = "center"|27
|align = "center"|17
|align = "center"|12
|align = "center"|8
|align = "center"|5
|align = "center"|3
|-
|align = "center"|'''SERMs'''
|align = "center"|0
|align = "center"|0
|align = "center"|0
|align = "center"|0
|align = "center"|0
|align = "center"|9
|align = "center"|14
|align = "center"|12
|align = "center"|12
|-
|}
==Clinical Trials==
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|align = "center" bgcolor = "#FFFF99"|'''Trial No.'''
|align = "center" bgcolor = "#FFFF99"|'''Condition'''
|bgcolor = "#FFFF99"|'''Description'''
|align = "center" bgcolor = "#FFFF99"|'''Intervention'''
|align = "center" bgcolor = "#FFFF99"|'''Therapy'''
|align = "center" bgcolor = "#FFFF99"|'''Route of admn'''
|align = "center" bgcolor = "#FFFF99"|'''Sponsors & Collaborators'''
|align = "center" bgcolor = "#FFFF99"|'''Phase'''
|align = "center" bgcolor = "#FFFF99"|'''Date'''
|-
|align = "center"|1
|align = "center"|Postmenopausal Osteoporosis
|[http://clinicaltrials.gov/ct/show/NCT00405392?order=13 Investigate Patient Preference On Dosing In Ibandronate And Risedronate in korean women ]
|align = "center"| Ibandronate
|align = "center"| Drug
|align = "center"|Oral
|align = "center"| GlaxoSmithKline
|align = "center"|Phase IV
|align = "center"|May-07
|-
|align = "center"|2
|align = "center"|Osteoporosis Osteopenia
|[http://clinicaltrials.gov/ct/show/NCT00145977?order=14 Texture Analysis for Postmenopausal Osteoporosis]
|align = "center"|Alendronate
|align = "center"|Drug
|align = "center"|Oral
|align = "center"|University of Chicago
|align = "center"| -
|align = "center"|Mar-07
|-
|align = "center"|3
|align = "center"|Osteoporosis
|align = "center"|[http://clinicaltrials.gov/ct/show/NCT00471237?order=18 A Phase II Study Evaluating SB-751689 in Post-Menopausal Women With Osteoporosis.]
|align = "center"|SB-751689
|align = "center"|Drug
|align = "center"|Oral
|align = "center"| GlaxoSmithKline
|align = "center"|Phase II
|align = "center"|May-07
|-
|align = "center"|4
|align = "center"|Osteoporosis
|[http://clinicaltrials.gov/ct/show/NCT00432692?order=15 Fall prevention program ]
|align = "center"|Procedure
| -
| -
|align = "center"|Sint Maartenskliniek ZonMw: The Netherlands Organisation for Health Research and Development
|align = "center"|
|align = "center"|Apr-07
|-
|align = "center"|5
|align = "center"|Osteoporosis Osteopenia
|[http://clinicaltrials.gov/ct/show/NCT00491920?order=16 High Dosage Vitamin D and Osteoporosis]
|align = "center"|Cholecalciferol
|align = "center"|Drug
|align = "center"|Oral
|align = "center"|University Hospital of North Norway
|align = "center"|Phase IV
|align = "center"|Jun-07
|-
|align = "center"|6
|align = "center"|Osteoporosis
|[http://clinicaltrials.gov/ct/show/NCT00479037?order=19 Effect of PTH(1-84)or Strontium Ranelate on Bone Formation Measured by Bone Markers]
|align = "center"|Parathyronine hormone
|align = "center"|Drug
|align = "center"|Oral
|align = "center"|Nycomed
|align = "center"|Phase IV
|align = "center"|May-07
|-
|align = "center"|7
|align = "center"|Post-Menopausal Osteoporosis
|[http://clinicaltrials.gov/ct/show/NCT00493532?order=20 A Study of Quarterly Intravenous Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis.]
|align = "center"|ibandronate <nowiki>[</nowiki>Bonviva/Boniva<nowiki>]</nowiki>
|align = "center"|Drug
|align = "center"|Intravenous
|align = "center"|Hoffmann-La Roche
|align = "center"|Phase IV
|align = "center"|Jul-07
|-
|align = "center"|8
|align = "center"|Osteoporosis
|[http://clinicaltrials.gov/ct/show/NCT00414973?order=22 A Study for Patients With Osteoporosis]
|align = "center"|1.Salmon Calcitonin 2.Teriparatide
|align = "center"|Drug
|align = "center"|Nose/intravenous
|align = "center"|Eli Lilly and Company
|align = "center"| Phase III
|align = "center"|Jun-07
|-
|align = "center"|9
|align = "center"|Osteoporosis
|[http://clinicaltrials.gov/ct/show/NCT00404820?order=24 Safety/Efficacy of Zoledronic Acid and Alendronate on Bone Metabolism in Post Menopausal Women With Osteoporosis]
|align = "center"|Zoledronic acid and alendronate
|align = "center"|Drug
|align = "center"|Oral
|align = "center"|Novartis
|align = "center"| Phase III
|align = "center"|May-07
|-
|align = "center"|10
|align = "center"|Osteoporosis
|[http://clinicaltrials.gov/ct/show/NCT00439647?order=26 Efficacy in Reducing Fractures and Safety of Zoledronic Acid in Men With Osteoporosis]
|align = "center"|zoledronic acid
|align = "center"|Drug
|align = "center"|Intravenous
|align = "center"|Novartis
|align = "center"| Phase III
|align = "center"|Feb-07
|-
|align = "center"|11
|align = "center"|Osteoporosis
|[http://clinicaltrials.gov/ct/show/NCT00154609?order=27 Davallia Divaricata BL: The Use of Traditional Chinese Native Medicine for Osteoporosis]
|align = "center"|Gu-Sui-Bu (Davallia Divaricata)
|align = "center"|Drug
|align = "center"|
|align = "center"|National Taiwan University Hospital
|align = "center"| Phase I
|align = "center"|Jan-07
|-
|align = "center"|12
|align = "center"|Osteoporosis
|[http://clinicaltrials.gov/ct/show/NCT00489918?order=44 Dose Ranging Study - Macroflux PTH in Postmenopausal Women With Osteoporosis]
|align = "center"|Macroflux PTH
|align = "center"|Drug
|align = "center"|Subcutaneuos
|align = "center"|The Macroflux Corporation
|align = "center"|Phase II
|align = "center"|Jun-07
|-
|align = "center"|13
|align = "center"|Osteoporosis
|[http://clinicaltrials.gov/ct/show/NCT00391404?order=41 Fosamax for Childhood Cancer Survivors]
|align = "center"|Alendronate
|align = "center"|Drug
|align = "center"|Oral
|align = "center"|Chinese University of Hong Kong
|align = "center"| Phase III
|align = "center"|Oct-06
|-
|align = "center"|14
|align = "center"|Osteoporosis
|[http://clinicaltrials.gov/ct/show/NCT00365456?order=40 This study is currently recruiting patients.]
|align = "center"|Parathyroid Hormone (PTH)
|align = "center"|Drug
|align = "center"|Subcutaneuos
|align = "center"| Nycomed
|align = "center"| -
|align = "center"|Feb-07
|-
|align = "center"|15
|align = "center"|Osteoporosis
|[http://clinicaltrials.gov/ct/show/NCT00421343?order=38 This study is currently recruiting patients.]
|align = "center"|Alendronate with cholecalciferol and Os-Cal with extra D
|align = "center"|Drug
|align = "center"|Oral
|align = "center"|National Institute on Aging (NIA),Glaxosmithkline
|align = "center"|Phase III
|align = "center"|May-07
|-
|align = "center"|16
|align = "center"|Primary Osteoporosis
|[http://clinicaltrials.gov/ct/show/NCT00447915?order=32 Phase II/III Clinical Study of R484iv (Ibandronic Acid) for Primary Osteoporosis]
|align = "center"|Ibandronic acid
|align = "center"|Drug
|align = "center"|Oral
|align = "center"| Chugai Pharmaceutical
|align = "center"|Phase III
|align = "center"|Mar-07
|-
|align = "center"|17
|align = "center"|Postmenopausal Osteoporosis, Back pain and Spinal Fracture
|[http://clinicaltrials.gov/ct/show/NCT00343252?order=37 Effect of Teriparatide Compared to Risedronate on Back Pain in Women With a Spine Fracture Caused by Osteoporosis]
|Teriparatide and risedronate
|align = "center"|Drug
|align = "center"|Oral/Subcutaneuos
|align = "center"|Eli Lilly and Company
|align = "center"|Phase III
|align = "center"|Jul-07
|-
|align = "center"|18
|align = "center"|Osteoporosis
|align = "center"|[http://clinicaltrials.gov/ct/show/NCT00493623?order=50 BONDIR Study: A Study of Intravenous Bonviva (Ibandronate) After Recent Vertebral Osteoporotic Fracture in Patients With Osteoporosis.]
|align = "center"|Ibandronate <nowiki>[</nowiki>Bonviva/Boniva<nowiki>]</nowiki>
|align = "center"|Drug
|align = "center"|Intravenous
|align = "center"|Hoffmann-La Roche
|align = "center"|Phase III
|align = "center"|Jul-07
|-
|}

==Intellectual Property==
===Search strategy===
* '''Database/Vendor''': Micropat
* '''Search scope''': US Granted US Applications EP-A EP-B WO JP (bibliographic data only) DE-C,B DE-A DE-T DE-U GB-A FR-A; '''Claims'''
* '''Years''': Issue/Publication Date: >20051231
* '''Search String''': ((Osteoporosis OR (bone Near3 regeneration)) AND (treatment))
* '''Hits''': 1261/982 patents (with/with out family members)
* '''Date of search''': 14th September 2007

===Top players and IPC classes===

[[Image:Top players and IPC.jpeg|center|800 px|]]

===Geographical Distribution and Treatment Approaches===
[[Image:Osteoporosis -geographical.jpeg|center|800 px|]]

===IP activity and Treatment Approaches===
* Decline in the IP activity during 2006 and 2007 is due 18 months publication delay of patent document.
[[Image:Osteoporosis -year approach.jpeg|center|800 px|]]

==Conferences==
* [http://www.chinamed.com.cn/icobr2008/html/WelcomeAddress.html International Conference on Osteoporosis and Bone Research to be held on Oct 15-18, 2008 in Beijing, China.]
* [http://www.iofbonehealth.org/wco/2008/homepage.html 2008 IOF World Congress on Osteoporosis to be held on December 2-7, 2008, Bangkok, Thailand]
* [http://www.oarsi.org/meetings/07Congress/index.cfm 2007 World Congress on Osteoarthritis, December 6-9, 2007, Marriott Harbor Beach Resort & Spa in fabulous Ft. Lauderdale, Florida]
* [http://www.asbmr.org/meeting/index.cfm American Society of Bone and Mineral Research Annual Meeting, September 12-16, 2008, Montreal, Canada]

File:Pathway products.jpg

2007-10-18T06:15:01Z

Rajiv:

Osteoporosis

2007-10-18T06:12:36Z

Rajiv: /* Pathways */

Osteoporosis is a systematic skeletal disease characterized by low bone mass, increase of bone fragility and susceptibility to fracture.

'''Types of Osteoporosis and its causes'''
#'''Primary osteoporosis(Type I (postmenopausal) or Type II (senile) )''':
##''Type I (postmenopausal)'': Generally develops in women after menopause when the amount of estrogen in the body greatly decreases. This process leads to an increase in the resorption of bone (the bones loses substance).
##''Type II (senile)'': This involves a thinning of both the trabecular bone (the spongy bone inside of the hard cortical bone) and the hard cortical bone. This process often leads to hip and vertebral body (in the spine) fractures.
#'''Secondary osteoporosis''': Secondary osteoporosis has the same symptoms as primary osteoporosis. However, it occurs as a result of having certain medical conditions, such as hyperthyroidism or leukemia. It may also occur as a result of taking medications known to cause bone breakdown, such as oral or high-dose inhaled corticosteroids (if used for more than 6 months), too high a dose of thyroid replacement, or aromatase inhibitors (used to treat breast cancer).
#'''Osteogenesis imperfecta''': Osteogenesis imperfecta is a rare form of osteoporosis that is present at birth. Osteogenesis imperfecta causes bones to break for no apparent reason.
#'''Idiopathic juvenile osteoporosis''':Idiopathic juvenile osteoporosis is rare. It occurs in children between the ages of 8 and 14 or during times of rapid growth. There is no known cause for this type of osteoporosis, in which there is too little bone formation or excessive bone loss.

==Incidence and prevalence==
[[Image:Osteoporosis incidence.jpg|thumb|center|500px]]
===Incidence===
* 1 in 3 women over 50 will suffer a fracture due to osteoporosis; this increases to 1 in 2 over 60.
* 1 in 5 men over 50 will suffer a fracture due to osteoporosis; this increases to 1 in 3 over 60.
* Approximately 1.6 million hip fractures occur each year worldwide, the incidence is set to increase to 6.3 million by 2050.
* The highest risk of hip fractures are seen in Norway, Sweden, Iceland, Denmark and the USA.
* Currently, there is an increasing incidence of hip fractures in the developed cities in Asia. 1 out of 4 hip fractures occur in Asia and Latin America. This number of hip fractures will increase to 1 in 2 by 2050.
* In the Middle East, the burden of osteoporosis in the general population is expected to increase and is becoming a heavy financial burden.7
* The annual incidence rate of osteoporotic fractures in women is greater than the combined incidence rates of heart attack, stroke and breast cancer. ([[Media:Osteoporosis_factsheet.pdf|International osteoporosis foundation]])

===Prevalence===
*28 million Americans (10 million with osteoporosis; 18 million with low bone mass); eight million American women and 2 million men (NWHIC)(approx 1 in 9 or 10.29% or 28 million people in USA ).
*Total prevalence rate of osteoporosis in the middle- aged and elderly in China was 16. 1% in 2002. The prevalence rate among males was 11. 5% and among females was 19. 9%.
*Prevalence increase to 2.2 million in 2006 and 3 million in 2021 in Australia.
*The prevalence of Khon Kaen (Thai rural area) women has osteporosis in femoral neck and lumbar spine is 19.3% and 24.7% respectively. ([[Media:Osteoporosis_factsheet.pdf|International osteoporosis foundation]])

{|border="2" cellspacing="0" cellpadding="4" width="100%"
|align = "center" bgcolor = "#FFFF99"|'''S.NO'''
|bgcolor = "#FFFF99"|'''Country/Region'''
|bgcolor = "#FFFF99"|'''Extrapolated Prevalence'''
|-
|align = "center"|1
|USA
|10 million cases (80% cases are women and 20% cases are men)
|-
|align = "center"|2
|Australia
|2.2 million
|-
|align = "center"|3
|Middle east
|18,603,593
|-
|align = "center"|4
|Africa
|47,233,590
|-
|align = "center"|5
|Asia
|359,862,754
|-
|align = "center"|6
|Europe
|80,590,570
|-
|}

==Product Information==
[[Image:osteoporosis.jpg|800 px|center|thumb| Overall categorization of osteoporosis treatments]]
===Products in market===

{|border="2" cellspacing="0" cellpadding="4" width="100%"
|bgcolor = "#FFFF99"|'''Generic'''
|bgcolor = "#FFFF99"|'''Brand'''
|bgcolor = "#FFFF99"|'''Current Status'''
|bgcolor = "#FFFF99"|'''Type'''
|bgcolor = "#FFFF99"|'''Company'''
|-
|bgcolor = "#CCFFCC" colspan = "5"|'''Antiresorptives'''
|-
|align = "center" colspan = "5"|'''Bisphosphonates'''
|-
|Alendronate
|FOSAMAX®
|Approved by US
|Postmenopausal
|[http://www.merck.com/product/ Merck]
|-
|Risedronate
|Actonel®
|Approved by US/ES
|Postmenopausal
|[http://en.sanofi-aventis.com/ Sanofi-Aventis/Procter & Gamble]
|-
|Ibandronate
|Boniva™
|Approved by US
|Postmenopausal
|[http://www.roche.com/home.html Roche]
|-
|Etidronate
|Didronel
|Off Label
| 
|[http://www.pgpharma.com/consumer_didronel.shtml Proctor And Gamble]
|-
|Zoledronic Acid
|Aclasta
|Approved
|Postmenopausal
|[http://www.medicalnewstoday.com/articles/80208.php Novartis]
|-
|align = "center" colspan = "5"|'''Selective Estrogen Receptor Modulators'''
|-
|Raloxifene
|Evista®
|Approved by US
|Osteoporosis
|[http://www.lilly.com/ Eli lilly]
|-
|align = "center" colspan = "5"|'''Hormone Replacement Therapy'''
|-
|Conjugated estrogen
|Premarin®
|Approved by US
|Postmenopausal
|[http://www.wyeth.com/ Wyeth]
|-
|Conjugated estrogen
|Cenestin™
|Approved by US
|Postmenopausal
|[http://www.drugdigest.org/DD/HC/HCDrugClass/0,4055,34-19,00.html Duramed]
|-
|Esterified estrogens
|Estratab®
|Approved by US
|Postmenopausal
|[http://www.solvay.com/ Solvay]
|-
|Esterified estrogens
|Menesta
|Approved by US
|Postmenopausal
|[http://www.google.co.in/url?sa=t&ct=res&cd=1&url=http%3A%2F%2Fwww.monarchpharm.com%2Findex.cgi%3FCONTEXT%3Dpoalph%26BISKIT%3D95434236815619&ei=bfO_Rpz8Io66sgK63ZS5CA&usg=AFQjCNEFn9uNNf941eVdhDU28dKL-77PGA&sig2=TS_t-tguidki-FvhYmkiMA Monarch]
|-
|Estradiol Transdermal System
|Menostar
|Approved by US
|Postmenopausal
|[http://www.menostar-us.com/HCP/index.html Bayer]
|-
|Estradiol Transdermal System
|Vivelle Dot
|Approved by US
|Postmenopausal
|[http://www.noven.com/PR052002.htm Noven]
|-
|Estradiol
|Estrace®
|Approved by US
|Postmenopausal
|[http://www.bms.com/landing/data/index.html Bristol-Myers Squibb]
|-
|Estradiol
|Gynodiol
|Approved by US
|Postmenopausal
|[http://www.novavax.com/ Novavax]
|-
|Tibolone
|Livifem
| 
|Postmenopausal
| 
|-
|align = "center" colspan = "5"|'''Calcitonin'''
|-
|Calcitonin Salmon Injection
|Miacalcin®
|Approved by US
|Postmenopausal
|[http://www.novartis.com/ Novartis]
|-
|Calcitonin Salmon Nasal Spray
|Miacalcin®
|Approved by US
|Postmenopausal
|[http://www.novartis.com/ Novartis]
|-
|Calcitonin Salmon Nasal Spray
|Fortical®
|Approved by US
|Postmenopausal
| 
|-
|bgcolor = "#CCFFCC" colspan = "5"|'''Bone Forming Drugs'''
|-
|Teripratide
|Forteo®
|Approved by US
|Osteoporosis
|[http://www.pfizer.com/home/ Pfizer]
|-
|bgcolor = "#CCFFCC" colspan = "5"|'''Drugs with Complex Mechanisms of Action'''
|-
|Strontium Ranelate
|Protelos
|Not approved in USA
|Postmenopausal osteoporosis
|[http://www.servier.com/pro/osteoporose/home_osteo.asp Servier]
|-
|Vitamin D
| 
| 
| 
| 
|-
|Calcium
| 
|[http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-22573.htm FDA is considering amending rules so that companies can now claim that calcium and Vitamin D in their food supplements can prevent osteoprorosis in all ages and both sexes]
| 
|FDA
|-
|}

===Product pipeline===
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|align = "center" bgcolor = "#FFFF99" colspan = "5" rowspan = "1" |'''Product Pipeline'''
|-
|colspan = "5"|
|-
|align = "center"|'''DRUG'''
|align = "center"|'''COMPANY'''
|align = "center"|'''DESCRIPTION'''
|align = "center"|'''STAGE'''
|-
|colspan = "5"|'''RANKL Inhibitors'''
|-
|align = "center"|Denosumab
|align = "center"|[http://www.alantos.com/investors/pipe.jsp/ Atlantos, Amgen]
|align = "center"|A monoclonal antibody
|align = "center"|3
|align = "center"|
|-
|colspan = "5"|'''Bisphosphonates'''
|-
|align = "center"|Minodronate (YM529)
|align = "center"|Astellas
|align = "center"|Nitrogen containing bisphosphonate
|align = "center"| 
|align = "center"| 
|-
|colspan = "5"|'''Calcium Antagonist'''
|-
|align = "center"|423557
|align = "center"|[http://www.gsk.com/investors/reps04/20F-2004.pdf Glaxosmithkline]
|align = "center"| 
|align = "center"|1
|-
|align = "center"|423562
|align = "center"|[http://www.gsk.com/investors/reps04/20F-2004.pdf Glaxosmithkline]
|align = "center"| 
|align = "center"|1
|-
|align = "center"|Calcilytics (751689)
|align = "center"|[http://www.npsp.com/drug_development/dd_calcilytics.php/ NPS and Glaxosmithkline]
|align = "center"|Calcilytics antagonize calcium receptors on parathyroid glands resulting in a transient release of the body<nowiki>’</nowiki>s own stores of parathyroid hormone (PTH).
|align = "center"|1
|-
|colspan = "5"|'''Parathyroid Hormone'''
|-
|align = "center"|768974
|align = "center"|[http://www.gsk.com/investors/product_pipeline/docs/pipeline.pdf/ Glaxosmithkline]
|align = "center"|Parathyroid Hormone Agonist
|align = "center"|1
|-
|align = "center"|Preos (rDNA origin)
|align = "center"|[http://www.npsp.com/drug_development/dd_calcilytics.php NPS]
|align = "center"|Recombinant Parathyroid Hormone
|align = "center"|Registration Filed
|-
|align = "center"|PTH1-34
|align = "center"|[http://www.nastech.com/nastech/pipeline/ Nastech]
|align = "center"|Intranasal Parathyroid hormone
|align = "center"|2
|align = "center"|
|-
|align = "center"|PTH1-34
|align = "center"|[http://www.emisphere.com/pc_pp.asp Novartis, Emisphere]
|align = "center"|Oral Parathyroid hormone
|align = "center"|1
|align = "center"|
|-
|align = "center"|PTH Analogs
|align = "center"|[http://www.unigene.com/products/product_pipeline.php/ Unigene]
|align = "center"| 
|align = "center"|2
|-
|colspan = "5"|'''Cathepsin k Inhibitor'''
|-
|align = "center"|Relacatib (SB-462795)
|align = "center"|[http://www.gsk.com/investors/product_pipeline/docs/pipeline.pdf/ GlaxoSmithkline]
|align = "center"| 
|align = "center"|1
|-
|align = "center"|AAE581
|align = "center"|[http://www.asbmr.org/news/press_releases/2005/royrelease.cfm Novartis]
|align = "center"| 
|align = "center"| 
|-
|align = "center"|MK-0822
|align = "center"|[http://www.merck.com/finance/annualreport/ar2006/pipeline.html/ Canadian Institutes of Health Research, Merck]
|align = "center"| 
|align = "center"|2
|-
|colspan = "5"|'''Selective Estrogen Receptor Modulators'''
|-
|align = "center"|Bazedoxifene
|align = "center"|[http://clinicaltrials.gov/ct/gui/search?term=bazedoxifene&submit=Search/ Wyeth, Ligand]
|align = "center"|A Third-Generation Selective Estrogen Receptor Modulator for Treatment of Postmenopausal Osteoporosis
|align = "center"| 
|-
|align = "center"|Lasofoxifene (Oporia)
|align = "center"|[http://www.ligand.com/collaborations.php#Leading/ Pfizer,Ligand]
|align = "center"|A Third-Generation Selective Estrogen Receptor Modulator for Treatment of Postmenopausal Osteoporosis
|align = "center"|NDA
|-
|align = "center"|Arzoxifene
|align = "center"|[http://www.lillytrials.com/ Eli lilly]
|align = "center"| 
|align = "center"| 
|-
|align = "center"|Taromifene (Fareston)
|align = "center"|[http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1550783 Orion]
|align = "center"| 
|align = "center"| 
|-
|colspan = "5"|'''Calcitonin'''
|-
|align = "center"| 
|align = "center"|[http://www.nastech.com/nastech/pipeline/ Nastech]
|align = "center"| 
|align = "center"|NDA
|-
|align = "center"|Salmon calcitonin
|align = "center"|[http://www.unigene.com/products/product_pipeline.php/ Unigene]
|align = "center"|Nasal
|align = "center"|3
|-
|align = "center"|Salmon calcitonin
|align = "center"|[http://www.unigene.com/products/product_pipeline.php/ Unigene]
|align = "center"|Oral
|align = "center"|2
|-
|align = "center"|Salmon calcitonin (SMC 021)
|align = "center"|[http://www.emisphere.com/pc_osc.asp Novartis, Emisphere, Nordic]
|align = "center"|Oral
|align = "center"|3
|-
|align = "center"|Salmon calcitonin
|align = "center"|[http://www.sbtdc.org/technology/sbir/nobex.pdf Nobex (Biocon)]
|align = "center"|Oral
|align = "center"|3
|-
|colspan = "5"|'''Vitamin D'''
|-
|align = "center"|ED 71
|align = "center"|[http://www.chugai-pharm.co.jp/english/ir/pipeline/index.html<nowiki> </nowiki>Bone/ Chugai]
|align = "center"|Activted Vitamin D derivative
|align = "center"|3
|-
|align = "center"|Doxercalciferol (Hectorol)
|align = "center"|[http://www.centerwatch.com/patient/drugs/dru614.html Bone Care Int.]
|align = "center"|Synthetic Vitamin D
|align = "center"| 
|-
|colspan = "5"|'''Nitrates: Research is going on to determine if nitrates can prevent osteoporosis in women.'''
|-
|align = "center"|Isosorbide mononitrate
|align = "center"|[http://clinicaltrials.gov/ct/show/ St. Michael<nowiki>’</nowiki>s Hospital, Toronto]
|align = "center"| 
|align = "center"|3
|-
|align = "center"|Nitroglycerine
|align = "center"|[http://clinicaltrials.gov/ct/show/NCT00252421 Canadian Institutes of Health Research (CIHR)]
|align = "center"| 
|align = "center"|3
|-
|align = "center"|HCT 1026 (NO releasing Derivative of NSAIDs)
|align = "center"|[http://www.centerwatch.com/bookstore/nmt/nmtb_osteoporosis.pdf NicOx SA]
|align = "center"| 
|align = "center"|2
|align = "center"| 
|-
|colspan = "5"|'''Selective Androgen Receptor Modulator (SARM)'''
|-
|align = "center"|LGD-2941
|align = "center"|[http://investors.ligand.com/releasedetail.cfm?ReleaseID=258992 Ligand, TAP]
|align = "center"| 
|align = "center"|3
|-
|align = "center"|LGD-3303
|align = "center"|[http://www.ligand.com/research.php Ligand, TAP]
|align = "center"| 
|align = "center"|3
|-
|align = "center"|Ostarine
|align = "center"|[http://www.gtxinc.com/tech/pipeline.htm GTx]
|align = "center"| 
|align = "center"|2
|-
|align = "center"|Intermittent Versus Continuous Androgen Suppression
|align = "center"|[http://clinicaltrials.gov/ct/show/NCT00228124?order=111/ Ontario Cancer Research Network]
|align = "center"| 
|align = "center"| 
|-
|align = "center" bgcolor = "#FFFF99" colspan = "5"|
|-
|align = "center"|Mk 0733
|align = "center"|[http://www.merck.com/finance/annualreport/ar2006/pipeline.html Merck]
|align = "center"| 
|align = "center"|1
|-
|align = "center"|TH0229
|align = "center"|Theratechnologies
|align = "center"| 
|align = "center"| 
|align = "center"| 
|-
|align = "center"|c-8500
|align = "center"|Merck
|align = "center"| 
|align = "center"|2
|align = "center"| 
|-
|align = "center"|c-3578
|align = "center"|Merck
|align = "center"| 
|align = "center"|2
|align = "center"| 
|-
|align = "center"|apomorphine
|align = "center"|Ilex Oncology
|align = "center"| 
|align = "center"|2
|align = "center"| 
|-
|align = "center"|Genistein
|align = "center"|[http://www.newsrx.com/newsletters/Drug-Law-Weekly/2007-07-10/2207102007866DL.html<nowiki> </nowiki> Primus Pharmaceuticals, Inc.] 
|align = "center"|isoflavones have been shown to interact with animal and human estrogen receptors, causing effects in the body similar to those caused by the hormone estrogen.
|align = "center"|Available
|-
|align = "center"|Soy estrogens
|align = "center"|[http://clinicaltrials.gov/ct/gui/show/NCT00076050?order=61/ (NIAMS)]
|align = "center"| 
|align = "center"|3
|-
|align = "center"|Hesperidin
|align = "center"|[http://clinicaltrials.gov/ct/gui/show/NCT00330096?order=51/ Nestle clinical nutrition]
|align = "center"| 
|align = "center"|3
|-
|align = "center"|Davallia Divaricata
|align = "center"|[http://clinicaltrials.gov/ct/gui/show/NCT00154609?order=63/ National Taiwan University Hospital]
|align = "center"| 
|align = "center"|1
|-
|align = "center"|Atorvaststin
|align = "center"| [http://clinicaltrials.gov/ct/gui/show/NCT00120133?order=9}]
|align = "center"| 
|-
|align = "center"|Potassium citrate
|align = "center"|[http://clinicaltrials.gov/ct/gui/show/NCT00357331?order=56/ Weill Medical College of Cornell University]
|align = "center"| 
|align = "center"|4
|-
|align = "center"|Phosphorus
|align = "center"|[http://clinicaltrials.gov/ct/gui/show/NCT00074711?order=60/ National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)]
|align = "center"| 
|align = "center"|3
|-
|}

===Devices===
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|[http://www.hiprotector.com/wkit.html Hip Protector]
|Hip pads with special underwear with pockets
| 
|Children<nowiki>’</nowiki>s Mercy Hospital Kansas City
| 
|-
|}

===Pathways===

[[Image:pathway_products.jpg|800 px|center|thumb| PRODUCT PATHWAY]]

==Market Information==
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|align = "center" bgcolor = "#FFFF99" colspan = "10"|Prescription Trends in USA
|-
|align = "center" colspan = "10"|Source: Arch Intern Med. 2004;164:1525-1530
|-
|align = "center"| 
|align = "center"|'''1988'''
|align = "center"|'''1990'''
|align = "center"|'''1992'''
|align = "center"|'''1994'''
|align = "center"|'''1996'''
|align = "center"|'''1998'''
|align = "center"|'''2000'''
|align = "center"|'''2002'''
|align = "center"|'''2003'''
|-
|align = "center"|'''Patients (Millions)'''
|align = "center"|NA
|align = "center"|0.6
|align = "center"|0.6
|align = "center"|0.5
|align = "center"|1.2
|align = "center"|2
|align = "center"|2.6
|align = "center"|2.8
|align = "center"|3.6
|-
|align = "center" colspan = "10"|'''Drugs Prescribed %'''
|-
|align = "center"|'''Bisphosphonates (total)'''
|align = "center"|1
|align = "center"|9
|align = "center"|17
|align = "center"|14
|align = "center"|48
|align = "center"|49
|align = "center"|54
|align = "center"|71
|align = "center"|73
|-
|align = "center"|Alendronate
|align = "center"|0
|align = "center"|0
|align = "center"|0
|align = "center"|0
|align = "center"|45
|align = "center"|47
|align = "center"|48
|align = "center"|53
|align = "center"|51
|-
|align = "center"|Risedronate
|align = "center"|0
|align = "center"|0
|align = "center"|0
|align = "center"|0
|align = "center"|0
|align = "center"|0
|align = "center"|4
|align = "center"|17
|align = "center"|22
|-
|align = "center"|Etidronate
|align = "center"|1
|align = "center"|9
|align = "center"|17
|align = "center"|14
|align = "center"|3
|align = "center"|1
|align = "center"|1
|align = "center"|0
|align = "center"|0
|-
|align = "center"|'''Calcium'''
|align = "center"|39
|align = "center"|33
|align = "center"|33
|align = "center"|43
|align = "center"|31
|align = "center"|26
|align = "center"|29
|align = "center"|26
|align = "center"|24
|-
|align = "center"|'''Calcitonins'''
|align = "center"|5
|align = "center"|9
|align = "center"|10
|align = "center"|13
|align = "center"|13
|align = "center"|16
|align = "center"|15
|align = "center"|7
|align = "center"|5
|-
|align = "center"|'''Estrogens'''
|align = "center"|35
|align = "center"|25
|align = "center"|33
|align = "center"|27
|align = "center"|17
|align = "center"|12
|align = "center"|8
|align = "center"|5
|align = "center"|3
|-
|align = "center"|'''SERMs'''
|align = "center"|0
|align = "center"|0
|align = "center"|0
|align = "center"|0
|align = "center"|0
|align = "center"|9
|align = "center"|14
|align = "center"|12
|align = "center"|12
|-
|}
==Clinical Trials==
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|align = "center" bgcolor = "#FFFF99"|'''Trial No.'''
|align = "center" bgcolor = "#FFFF99"|'''Condition'''
|bgcolor = "#FFFF99"|'''Description'''
|align = "center" bgcolor = "#FFFF99"|'''Intervention'''
|align = "center" bgcolor = "#FFFF99"|'''Therapy'''
|align = "center" bgcolor = "#FFFF99"|'''Route of admn'''
|align = "center" bgcolor = "#FFFF99"|'''Sponsors & Collaborators'''
|align = "center" bgcolor = "#FFFF99"|'''Phase'''
|align = "center" bgcolor = "#FFFF99"|'''Date'''
|-
|align = "center"|1
|align = "center"|Postmenopausal Osteoporosis
|[http://clinicaltrials.gov/ct/show/NCT00405392?order=13 Investigate Patient Preference On Dosing In Ibandronate And Risedronate in korean women ]
|align = "center"| Ibandronate
|align = "center"| Drug
|align = "center"|Oral
|align = "center"| GlaxoSmithKline
|align = "center"|Phase IV
|align = "center"|May-07
|-
|align = "center"|2
|align = "center"|Osteoporosis Osteopenia
|[http://clinicaltrials.gov/ct/show/NCT00145977?order=14 Texture Analysis for Postmenopausal Osteoporosis]
|align = "center"|Alendronate
|align = "center"|Drug
|align = "center"|Oral
|align = "center"|University of Chicago
|align = "center"| -
|align = "center"|Mar-07
|-
|align = "center"|3
|align = "center"|Osteoporosis
|align = "center"|[http://clinicaltrials.gov/ct/show/NCT00471237?order=18 A Phase II Study Evaluating SB-751689 in Post-Menopausal Women With Osteoporosis.]
|align = "center"|SB-751689
|align = "center"|Drug
|align = "center"|Oral
|align = "center"| GlaxoSmithKline
|align = "center"|Phase II
|align = "center"|May-07
|-
|align = "center"|4
|align = "center"|Osteoporosis
|[http://clinicaltrials.gov/ct/show/NCT00432692?order=15 Fall prevention program ]
|align = "center"|Procedure
| -
| -
|align = "center"|Sint Maartenskliniek ZonMw: The Netherlands Organisation for Health Research and Development
|align = "center"|
|align = "center"|Apr-07
|-
|align = "center"|5
|align = "center"|Osteoporosis Osteopenia
|[http://clinicaltrials.gov/ct/show/NCT00491920?order=16 High Dosage Vitamin D and Osteoporosis]
|align = "center"|Cholecalciferol
|align = "center"|Drug
|align = "center"|Oral
|align = "center"|University Hospital of North Norway
|align = "center"|Phase IV
|align = "center"|Jun-07
|-
|align = "center"|6
|align = "center"|Osteoporosis
|[http://clinicaltrials.gov/ct/show/NCT00479037?order=19 Effect of PTH(1-84)or Strontium Ranelate on Bone Formation Measured by Bone Markers]
|align = "center"|Parathyronine hormone
|align = "center"|Drug
|align = "center"|Oral
|align = "center"|Nycomed
|align = "center"|Phase IV
|align = "center"|May-07
|-
|align = "center"|7
|align = "center"|Post-Menopausal Osteoporosis
|[http://clinicaltrials.gov/ct/show/NCT00493532?order=20 A Study of Quarterly Intravenous Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis.]
|align = "center"|ibandronate <nowiki>[</nowiki>Bonviva/Boniva<nowiki>]</nowiki>
|align = "center"|Drug
|align = "center"|Intravenous
|align = "center"|Hoffmann-La Roche
|align = "center"|Phase IV
|align = "center"|Jul-07
|-
|align = "center"|8
|align = "center"|Osteoporosis
|[http://clinicaltrials.gov/ct/show/NCT00414973?order=22 A Study for Patients With Osteoporosis]
|align = "center"|1.Salmon Calcitonin 2.Teriparatide
|align = "center"|Drug
|align = "center"|Nose/intravenous
|align = "center"|Eli Lilly and Company
|align = "center"| Phase III
|align = "center"|Jun-07
|-
|align = "center"|9
|align = "center"|Osteoporosis
|[http://clinicaltrials.gov/ct/show/NCT00404820?order=24 Safety/Efficacy of Zoledronic Acid and Alendronate on Bone Metabolism in Post Menopausal Women With Osteoporosis]
|align = "center"|Zoledronic acid and alendronate
|align = "center"|Drug
|align = "center"|Oral
|align = "center"|Novartis
|align = "center"| Phase III
|align = "center"|May-07
|-
|align = "center"|10
|align = "center"|Osteoporosis
|[http://clinicaltrials.gov/ct/show/NCT00439647?order=26 Efficacy in Reducing Fractures and Safety of Zoledronic Acid in Men With Osteoporosis]
|align = "center"|zoledronic acid
|align = "center"|Drug
|align = "center"|Intravenous
|align = "center"|Novartis
|align = "center"| Phase III
|align = "center"|Feb-07
|-
|align = "center"|11
|align = "center"|Osteoporosis
|[http://clinicaltrials.gov/ct/show/NCT00154609?order=27 Davallia Divaricata BL: The Use of Traditional Chinese Native Medicine for Osteoporosis]
|align = "center"|Gu-Sui-Bu (Davallia Divaricata)
|align = "center"|Drug
|align = "center"|
|align = "center"|National Taiwan University Hospital
|align = "center"| Phase I
|align = "center"|Jan-07
|-
|align = "center"|12
|align = "center"|Osteoporosis
|[http://clinicaltrials.gov/ct/show/NCT00489918?order=44 Dose Ranging Study - Macroflux PTH in Postmenopausal Women With Osteoporosis]
|align = "center"|Macroflux PTH
|align = "center"|Drug
|align = "center"|Subcutaneuos
|align = "center"|The Macroflux Corporation
|align = "center"|Phase II
|align = "center"|Jun-07
|-
|align = "center"|13
|align = "center"|Osteoporosis
|[http://clinicaltrials.gov/ct/show/NCT00391404?order=41 Fosamax for Childhood Cancer Survivors]
|align = "center"|Alendronate
|align = "center"|Drug
|align = "center"|Oral
|align = "center"|Chinese University of Hong Kong
|align = "center"| Phase III
|align = "center"|Oct-06
|-
|align = "center"|14
|align = "center"|Osteoporosis
|[http://clinicaltrials.gov/ct/show/NCT00365456?order=40 This study is currently recruiting patients.]
|align = "center"|Parathyroid Hormone (PTH)
|align = "center"|Drug
|align = "center"|Subcutaneuos
|align = "center"| Nycomed
|align = "center"| -
|align = "center"|Feb-07
|-
|align = "center"|15
|align = "center"|Osteoporosis
|[http://clinicaltrials.gov/ct/show/NCT00421343?order=38 This study is currently recruiting patients.]
|align = "center"|Alendronate with cholecalciferol and Os-Cal with extra D
|align = "center"|Drug
|align = "center"|Oral
|align = "center"|National Institute on Aging (NIA),Glaxosmithkline
|align = "center"|Phase III
|align = "center"|May-07
|-
|align = "center"|16
|align = "center"|Primary Osteoporosis
|[http://clinicaltrials.gov/ct/show/NCT00447915?order=32 Phase II/III Clinical Study of R484iv (Ibandronic Acid) for Primary Osteoporosis]
|align = "center"|Ibandronic acid
|align = "center"|Drug
|align = "center"|Oral
|align = "center"| Chugai Pharmaceutical
|align = "center"|Phase III
|align = "center"|Mar-07
|-
|align = "center"|17
|align = "center"|Postmenopausal Osteoporosis, Back pain and Spinal Fracture
|[http://clinicaltrials.gov/ct/show/NCT00343252?order=37 Effect of Teriparatide Compared to Risedronate on Back Pain in Women With a Spine Fracture Caused by Osteoporosis]
|Teriparatide and risedronate
|align = "center"|Drug
|align = "center"|Oral/Subcutaneuos
|align = "center"|Eli Lilly and Company
|align = "center"|Phase III
|align = "center"|Jul-07
|-
|align = "center"|18
|align = "center"|Osteoporosis
|align = "center"|[http://clinicaltrials.gov/ct/show/NCT00493623?order=50 BONDIR Study: A Study of Intravenous Bonviva (Ibandronate) After Recent Vertebral Osteoporotic Fracture in Patients With Osteoporosis.]
|align = "center"|Ibandronate <nowiki>[</nowiki>Bonviva/Boniva<nowiki>]</nowiki>
|align = "center"|Drug
|align = "center"|Intravenous
|align = "center"|Hoffmann-La Roche
|align = "center"|Phase III
|align = "center"|Jul-07
|-
|}

==Intellectual Property==
===Search strategy===
* '''Database/Vendor''': Micropat
* '''Search scope''': US Granted US Applications EP-A EP-B WO JP (bibliographic data only) DE-C,B DE-A DE-T DE-U GB-A FR-A; '''Claims'''
* '''Years''': Issue/Publication Date: >20051231
* '''Search String''': ((Osteoporosis OR (bone Near3 regeneration)) AND (treatment))
* '''Hits''': 1261/982 patents (with/with out family members)
* '''Date of search''': 14th September 2007

===Top players and IPC classes===

[[Image:Top players and IPC.jpeg|center|800 px|]]

===Geographical Distribution and Treatment Approaches===
[[Image:Osteoporosis -geographical.jpeg|center|800 px|]]

===IP activity and Treatment Approaches===
* Decline in the IP activity during 2006 and 2007 is due 18 months publication delay of patent document.
[[Image:Osteoporosis -year approach.jpeg|center|800 px|]]

==Conferences==
[http://www.chinamed.com.cn/icobr2008/html/WelcomeAddress.html International Conference on Osteoporosis and Bone Research to be held on Oct 15-18, 2008 in Beijing, China.]

[http://www.iofbonehealth.org/wco/2008/homepage.html 2008 IOF World Congress on Osteoporosis to be held on December 2-7, 2008 in Bangkok, Thailand]

[http://www.oarsi.org/meetings/07Congress/index.cfm 2007 World Congress on Osteoarthritis, being held December 6 - 9, 2007 at the Marriott Harbor Beach Resort & Spa in fabulous Ft. Lauderdale, Florida!]

Osteoporosis

2007-10-18T06:12:15Z

Rajiv: /* Devices */

Osteoporosis is a systematic skeletal disease characterized by low bone mass, increase of bone fragility and susceptibility to fracture.

'''Types of Osteoporosis and its causes'''
#'''Primary osteoporosis(Type I (postmenopausal) or Type II (senile) )''':
##''Type I (postmenopausal)'': Generally develops in women after menopause when the amount of estrogen in the body greatly decreases. This process leads to an increase in the resorption of bone (the bones loses substance).
##''Type II (senile)'': This involves a thinning of both the trabecular bone (the spongy bone inside of the hard cortical bone) and the hard cortical bone. This process often leads to hip and vertebral body (in the spine) fractures.
#'''Secondary osteoporosis''': Secondary osteoporosis has the same symptoms as primary osteoporosis. However, it occurs as a result of having certain medical conditions, such as hyperthyroidism or leukemia. It may also occur as a result of taking medications known to cause bone breakdown, such as oral or high-dose inhaled corticosteroids (if used for more than 6 months), too high a dose of thyroid replacement, or aromatase inhibitors (used to treat breast cancer).
#'''Osteogenesis imperfecta''': Osteogenesis imperfecta is a rare form of osteoporosis that is present at birth. Osteogenesis imperfecta causes bones to break for no apparent reason.
#'''Idiopathic juvenile osteoporosis''':Idiopathic juvenile osteoporosis is rare. It occurs in children between the ages of 8 and 14 or during times of rapid growth. There is no known cause for this type of osteoporosis, in which there is too little bone formation or excessive bone loss.

==Incidence and prevalence==
[[Image:Osteoporosis incidence.jpg|thumb|center|500px]]
===Incidence===
* 1 in 3 women over 50 will suffer a fracture due to osteoporosis; this increases to 1 in 2 over 60.
* 1 in 5 men over 50 will suffer a fracture due to osteoporosis; this increases to 1 in 3 over 60.
* Approximately 1.6 million hip fractures occur each year worldwide, the incidence is set to increase to 6.3 million by 2050.
* The highest risk of hip fractures are seen in Norway, Sweden, Iceland, Denmark and the USA.
* Currently, there is an increasing incidence of hip fractures in the developed cities in Asia. 1 out of 4 hip fractures occur in Asia and Latin America. This number of hip fractures will increase to 1 in 2 by 2050.
* In the Middle East, the burden of osteoporosis in the general population is expected to increase and is becoming a heavy financial burden.7
* The annual incidence rate of osteoporotic fractures in women is greater than the combined incidence rates of heart attack, stroke and breast cancer. ([[Media:Osteoporosis_factsheet.pdf|International osteoporosis foundation]])

===Prevalence===
*28 million Americans (10 million with osteoporosis; 18 million with low bone mass); eight million American women and 2 million men (NWHIC)(approx 1 in 9 or 10.29% or 28 million people in USA ).
*Total prevalence rate of osteoporosis in the middle- aged and elderly in China was 16. 1% in 2002. The prevalence rate among males was 11. 5% and among females was 19. 9%.
*Prevalence increase to 2.2 million in 2006 and 3 million in 2021 in Australia.
*The prevalence of Khon Kaen (Thai rural area) women has osteporosis in femoral neck and lumbar spine is 19.3% and 24.7% respectively. ([[Media:Osteoporosis_factsheet.pdf|International osteoporosis foundation]])

{|border="2" cellspacing="0" cellpadding="4" width="100%"
|align = "center" bgcolor = "#FFFF99"|'''S.NO'''
|bgcolor = "#FFFF99"|'''Country/Region'''
|bgcolor = "#FFFF99"|'''Extrapolated Prevalence'''
|-
|align = "center"|1
|USA
|10 million cases (80% cases are women and 20% cases are men)
|-
|align = "center"|2
|Australia
|2.2 million
|-
|align = "center"|3
|Middle east
|18,603,593
|-
|align = "center"|4
|Africa
|47,233,590
|-
|align = "center"|5
|Asia
|359,862,754
|-
|align = "center"|6
|Europe
|80,590,570
|-
|}

==Product Information==
[[Image:osteoporosis.jpg|800 px|center|thumb| Overall categorization of osteoporosis treatments]]
===Products in market===

{|border="2" cellspacing="0" cellpadding="4" width="100%"
|bgcolor = "#FFFF99"|'''Generic'''
|bgcolor = "#FFFF99"|'''Brand'''
|bgcolor = "#FFFF99"|'''Current Status'''
|bgcolor = "#FFFF99"|'''Type'''
|bgcolor = "#FFFF99"|'''Company'''
|-
|bgcolor = "#CCFFCC" colspan = "5"|'''Antiresorptives'''
|-
|align = "center" colspan = "5"|'''Bisphosphonates'''
|-
|Alendronate
|FOSAMAX®
|Approved by US
|Postmenopausal
|[http://www.merck.com/product/ Merck]
|-
|Risedronate
|Actonel®
|Approved by US/ES
|Postmenopausal
|[http://en.sanofi-aventis.com/ Sanofi-Aventis/Procter & Gamble]
|-
|Ibandronate
|Boniva™
|Approved by US
|Postmenopausal
|[http://www.roche.com/home.html Roche]
|-
|Etidronate
|Didronel
|Off Label
| 
|[http://www.pgpharma.com/consumer_didronel.shtml Proctor And Gamble]
|-
|Zoledronic Acid
|Aclasta
|Approved
|Postmenopausal
|[http://www.medicalnewstoday.com/articles/80208.php Novartis]
|-
|align = "center" colspan = "5"|'''Selective Estrogen Receptor Modulators'''
|-
|Raloxifene
|Evista®
|Approved by US
|Osteoporosis
|[http://www.lilly.com/ Eli lilly]
|-
|align = "center" colspan = "5"|'''Hormone Replacement Therapy'''
|-
|Conjugated estrogen
|Premarin®
|Approved by US
|Postmenopausal
|[http://www.wyeth.com/ Wyeth]
|-
|Conjugated estrogen
|Cenestin™
|Approved by US
|Postmenopausal
|[http://www.drugdigest.org/DD/HC/HCDrugClass/0,4055,34-19,00.html Duramed]
|-
|Esterified estrogens
|Estratab®
|Approved by US
|Postmenopausal
|[http://www.solvay.com/ Solvay]
|-
|Esterified estrogens
|Menesta
|Approved by US
|Postmenopausal
|[http://www.google.co.in/url?sa=t&ct=res&cd=1&url=http%3A%2F%2Fwww.monarchpharm.com%2Findex.cgi%3FCONTEXT%3Dpoalph%26BISKIT%3D95434236815619&ei=bfO_Rpz8Io66sgK63ZS5CA&usg=AFQjCNEFn9uNNf941eVdhDU28dKL-77PGA&sig2=TS_t-tguidki-FvhYmkiMA Monarch]
|-
|Estradiol Transdermal System
|Menostar
|Approved by US
|Postmenopausal
|[http://www.menostar-us.com/HCP/index.html Bayer]
|-
|Estradiol Transdermal System
|Vivelle Dot
|Approved by US
|Postmenopausal
|[http://www.noven.com/PR052002.htm Noven]
|-
|Estradiol
|Estrace®
|Approved by US
|Postmenopausal
|[http://www.bms.com/landing/data/index.html Bristol-Myers Squibb]
|-
|Estradiol
|Gynodiol
|Approved by US
|Postmenopausal
|[http://www.novavax.com/ Novavax]
|-
|Tibolone
|Livifem
| 
|Postmenopausal
| 
|-
|align = "center" colspan = "5"|'''Calcitonin'''
|-
|Calcitonin Salmon Injection
|Miacalcin®
|Approved by US
|Postmenopausal
|[http://www.novartis.com/ Novartis]
|-
|Calcitonin Salmon Nasal Spray
|Miacalcin®
|Approved by US
|Postmenopausal
|[http://www.novartis.com/ Novartis]
|-
|Calcitonin Salmon Nasal Spray
|Fortical®
|Approved by US
|Postmenopausal
| 
|-
|bgcolor = "#CCFFCC" colspan = "5"|'''Bone Forming Drugs'''
|-
|Teripratide
|Forteo®
|Approved by US
|Osteoporosis
|[http://www.pfizer.com/home/ Pfizer]
|-
|bgcolor = "#CCFFCC" colspan = "5"|'''Drugs with Complex Mechanisms of Action'''
|-
|Strontium Ranelate
|Protelos
|Not approved in USA
|Postmenopausal osteoporosis
|[http://www.servier.com/pro/osteoporose/home_osteo.asp Servier]
|-
|Vitamin D
| 
| 
| 
| 
|-
|Calcium
| 
|[http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-22573.htm FDA is considering amending rules so that companies can now claim that calcium and Vitamin D in their food supplements can prevent osteoprorosis in all ages and both sexes]
| 
|FDA
|-
|}

===Product pipeline===
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|align = "center" bgcolor = "#FFFF99" colspan = "5" rowspan = "1" |'''Product Pipeline'''
|-
|colspan = "5"|
|-
|align = "center"|'''DRUG'''
|align = "center"|'''COMPANY'''
|align = "center"|'''DESCRIPTION'''
|align = "center"|'''STAGE'''
|-
|colspan = "5"|'''RANKL Inhibitors'''
|-
|align = "center"|Denosumab
|align = "center"|[http://www.alantos.com/investors/pipe.jsp/ Atlantos, Amgen]
|align = "center"|A monoclonal antibody
|align = "center"|3
|align = "center"|
|-
|colspan = "5"|'''Bisphosphonates'''
|-
|align = "center"|Minodronate (YM529)
|align = "center"|Astellas
|align = "center"|Nitrogen containing bisphosphonate
|align = "center"| 
|align = "center"| 
|-
|colspan = "5"|'''Calcium Antagonist'''
|-
|align = "center"|423557
|align = "center"|[http://www.gsk.com/investors/reps04/20F-2004.pdf Glaxosmithkline]
|align = "center"| 
|align = "center"|1
|-
|align = "center"|423562
|align = "center"|[http://www.gsk.com/investors/reps04/20F-2004.pdf Glaxosmithkline]
|align = "center"| 
|align = "center"|1
|-
|align = "center"|Calcilytics (751689)
|align = "center"|[http://www.npsp.com/drug_development/dd_calcilytics.php/ NPS and Glaxosmithkline]
|align = "center"|Calcilytics antagonize calcium receptors on parathyroid glands resulting in a transient release of the body<nowiki>’</nowiki>s own stores of parathyroid hormone (PTH).
|align = "center"|1
|-
|colspan = "5"|'''Parathyroid Hormone'''
|-
|align = "center"|768974
|align = "center"|[http://www.gsk.com/investors/product_pipeline/docs/pipeline.pdf/ Glaxosmithkline]
|align = "center"|Parathyroid Hormone Agonist
|align = "center"|1
|-
|align = "center"|Preos (rDNA origin)
|align = "center"|[http://www.npsp.com/drug_development/dd_calcilytics.php NPS]
|align = "center"|Recombinant Parathyroid Hormone
|align = "center"|Registration Filed
|-
|align = "center"|PTH1-34
|align = "center"|[http://www.nastech.com/nastech/pipeline/ Nastech]
|align = "center"|Intranasal Parathyroid hormone
|align = "center"|2
|align = "center"|
|-
|align = "center"|PTH1-34
|align = "center"|[http://www.emisphere.com/pc_pp.asp Novartis, Emisphere]
|align = "center"|Oral Parathyroid hormone
|align = "center"|1
|align = "center"|
|-
|align = "center"|PTH Analogs
|align = "center"|[http://www.unigene.com/products/product_pipeline.php/ Unigene]
|align = "center"| 
|align = "center"|2
|-
|colspan = "5"|'''Cathepsin k Inhibitor'''
|-
|align = "center"|Relacatib (SB-462795)
|align = "center"|[http://www.gsk.com/investors/product_pipeline/docs/pipeline.pdf/ GlaxoSmithkline]
|align = "center"| 
|align = "center"|1
|-
|align = "center"|AAE581
|align = "center"|[http://www.asbmr.org/news/press_releases/2005/royrelease.cfm Novartis]
|align = "center"| 
|align = "center"| 
|-
|align = "center"|MK-0822
|align = "center"|[http://www.merck.com/finance/annualreport/ar2006/pipeline.html/ Canadian Institutes of Health Research, Merck]
|align = "center"| 
|align = "center"|2
|-
|colspan = "5"|'''Selective Estrogen Receptor Modulators'''
|-
|align = "center"|Bazedoxifene
|align = "center"|[http://clinicaltrials.gov/ct/gui/search?term=bazedoxifene&submit=Search/ Wyeth, Ligand]
|align = "center"|A Third-Generation Selective Estrogen Receptor Modulator for Treatment of Postmenopausal Osteoporosis
|align = "center"| 
|-
|align = "center"|Lasofoxifene (Oporia)
|align = "center"|[http://www.ligand.com/collaborations.php#Leading/ Pfizer,Ligand]
|align = "center"|A Third-Generation Selective Estrogen Receptor Modulator for Treatment of Postmenopausal Osteoporosis
|align = "center"|NDA
|-
|align = "center"|Arzoxifene
|align = "center"|[http://www.lillytrials.com/ Eli lilly]
|align = "center"| 
|align = "center"| 
|-
|align = "center"|Taromifene (Fareston)
|align = "center"|[http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1550783 Orion]
|align = "center"| 
|align = "center"| 
|-
|colspan = "5"|'''Calcitonin'''
|-
|align = "center"| 
|align = "center"|[http://www.nastech.com/nastech/pipeline/ Nastech]
|align = "center"| 
|align = "center"|NDA
|-
|align = "center"|Salmon calcitonin
|align = "center"|[http://www.unigene.com/products/product_pipeline.php/ Unigene]
|align = "center"|Nasal
|align = "center"|3
|-
|align = "center"|Salmon calcitonin
|align = "center"|[http://www.unigene.com/products/product_pipeline.php/ Unigene]
|align = "center"|Oral
|align = "center"|2
|-
|align = "center"|Salmon calcitonin (SMC 021)
|align = "center"|[http://www.emisphere.com/pc_osc.asp Novartis, Emisphere, Nordic]
|align = "center"|Oral
|align = "center"|3
|-
|align = "center"|Salmon calcitonin
|align = "center"|[http://www.sbtdc.org/technology/sbir/nobex.pdf Nobex (Biocon)]
|align = "center"|Oral
|align = "center"|3
|-
|colspan = "5"|'''Vitamin D'''
|-
|align = "center"|ED 71
|align = "center"|[http://www.chugai-pharm.co.jp/english/ir/pipeline/index.html<nowiki> </nowiki>Bone/ Chugai]
|align = "center"|Activted Vitamin D derivative
|align = "center"|3
|-
|align = "center"|Doxercalciferol (Hectorol)
|align = "center"|[http://www.centerwatch.com/patient/drugs/dru614.html Bone Care Int.]
|align = "center"|Synthetic Vitamin D
|align = "center"| 
|-
|colspan = "5"|'''Nitrates: Research is going on to determine if nitrates can prevent osteoporosis in women.'''
|-
|align = "center"|Isosorbide mononitrate
|align = "center"|[http://clinicaltrials.gov/ct/show/ St. Michael<nowiki>’</nowiki>s Hospital, Toronto]
|align = "center"| 
|align = "center"|3
|-
|align = "center"|Nitroglycerine
|align = "center"|[http://clinicaltrials.gov/ct/show/NCT00252421 Canadian Institutes of Health Research (CIHR)]
|align = "center"| 
|align = "center"|3
|-
|align = "center"|HCT 1026 (NO releasing Derivative of NSAIDs)
|align = "center"|[http://www.centerwatch.com/bookstore/nmt/nmtb_osteoporosis.pdf NicOx SA]
|align = "center"| 
|align = "center"|2
|align = "center"| 
|-
|colspan = "5"|'''Selective Androgen Receptor Modulator (SARM)'''
|-
|align = "center"|LGD-2941
|align = "center"|[http://investors.ligand.com/releasedetail.cfm?ReleaseID=258992 Ligand, TAP]
|align = "center"| 
|align = "center"|3
|-
|align = "center"|LGD-3303
|align = "center"|[http://www.ligand.com/research.php Ligand, TAP]
|align = "center"| 
|align = "center"|3
|-
|align = "center"|Ostarine
|align = "center"|[http://www.gtxinc.com/tech/pipeline.htm GTx]
|align = "center"| 
|align = "center"|2
|-
|align = "center"|Intermittent Versus Continuous Androgen Suppression
|align = "center"|[http://clinicaltrials.gov/ct/show/NCT00228124?order=111/ Ontario Cancer Research Network]
|align = "center"| 
|align = "center"| 
|-
|align = "center" bgcolor = "#FFFF99" colspan = "5"|
|-
|align = "center"|Mk 0733
|align = "center"|[http://www.merck.com/finance/annualreport/ar2006/pipeline.html Merck]
|align = "center"| 
|align = "center"|1
|-
|align = "center"|TH0229
|align = "center"|Theratechnologies
|align = "center"| 
|align = "center"| 
|align = "center"| 
|-
|align = "center"|c-8500
|align = "center"|Merck
|align = "center"| 
|align = "center"|2
|align = "center"| 
|-
|align = "center"|c-3578
|align = "center"|Merck
|align = "center"| 
|align = "center"|2
|align = "center"| 
|-
|align = "center"|apomorphine
|align = "center"|Ilex Oncology
|align = "center"| 
|align = "center"|2
|align = "center"| 
|-
|align = "center"|Genistein
|align = "center"|[http://www.newsrx.com/newsletters/Drug-Law-Weekly/2007-07-10/2207102007866DL.html<nowiki> </nowiki> Primus Pharmaceuticals, Inc.] 
|align = "center"|isoflavones have been shown to interact with animal and human estrogen receptors, causing effects in the body similar to those caused by the hormone estrogen.
|align = "center"|Available
|-
|align = "center"|Soy estrogens
|align = "center"|[http://clinicaltrials.gov/ct/gui/show/NCT00076050?order=61/ (NIAMS)]
|align = "center"| 
|align = "center"|3
|-
|align = "center"|Hesperidin
|align = "center"|[http://clinicaltrials.gov/ct/gui/show/NCT00330096?order=51/ Nestle clinical nutrition]
|align = "center"| 
|align = "center"|3
|-
|align = "center"|Davallia Divaricata
|align = "center"|[http://clinicaltrials.gov/ct/gui/show/NCT00154609?order=63/ National Taiwan University Hospital]
|align = "center"| 
|align = "center"|1
|-
|align = "center"|Atorvaststin
|align = "center"| [http://clinicaltrials.gov/ct/gui/show/NCT00120133?order=9}]
|align = "center"| 
|-
|align = "center"|Potassium citrate
|align = "center"|[http://clinicaltrials.gov/ct/gui/show/NCT00357331?order=56/ Weill Medical College of Cornell University]
|align = "center"| 
|align = "center"|4
|-
|align = "center"|Phosphorus
|align = "center"|[http://clinicaltrials.gov/ct/gui/show/NCT00074711?order=60/ National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)]
|align = "center"| 
|align = "center"|3
|-
|}

===Devices===
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|[http://www.hiprotector.com/wkit.html Hip Protector]
|Hip pads with special underwear with pockets
| 
|Children<nowiki>’</nowiki>s Mercy Hospital Kansas City
| 
|-
|}

===Pathways===

==Market Information==
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|align = "center" bgcolor = "#FFFF99" colspan = "10"|Prescription Trends in USA
|-
|align = "center" colspan = "10"|Source: Arch Intern Med. 2004;164:1525-1530
|-
|align = "center"| 
|align = "center"|'''1988'''
|align = "center"|'''1990'''
|align = "center"|'''1992'''
|align = "center"|'''1994'''
|align = "center"|'''1996'''
|align = "center"|'''1998'''
|align = "center"|'''2000'''
|align = "center"|'''2002'''
|align = "center"|'''2003'''
|-
|align = "center"|'''Patients (Millions)'''
|align = "center"|NA
|align = "center"|0.6
|align = "center"|0.6
|align = "center"|0.5
|align = "center"|1.2
|align = "center"|2
|align = "center"|2.6
|align = "center"|2.8
|align = "center"|3.6
|-
|align = "center" colspan = "10"|'''Drugs Prescribed %'''
|-
|align = "center"|'''Bisphosphonates (total)'''
|align = "center"|1
|align = "center"|9
|align = "center"|17
|align = "center"|14
|align = "center"|48
|align = "center"|49
|align = "center"|54
|align = "center"|71
|align = "center"|73
|-
|align = "center"|Alendronate
|align = "center"|0
|align = "center"|0
|align = "center"|0
|align = "center"|0
|align = "center"|45
|align = "center"|47
|align = "center"|48
|align = "center"|53
|align = "center"|51
|-
|align = "center"|Risedronate
|align = "center"|0
|align = "center"|0
|align = "center"|0
|align = "center"|0
|align = "center"|0
|align = "center"|0
|align = "center"|4
|align = "center"|17
|align = "center"|22
|-
|align = "center"|Etidronate
|align = "center"|1
|align = "center"|9
|align = "center"|17
|align = "center"|14
|align = "center"|3
|align = "center"|1
|align = "center"|1
|align = "center"|0
|align = "center"|0
|-
|align = "center"|'''Calcium'''
|align = "center"|39
|align = "center"|33
|align = "center"|33
|align = "center"|43
|align = "center"|31
|align = "center"|26
|align = "center"|29
|align = "center"|26
|align = "center"|24
|-
|align = "center"|'''Calcitonins'''
|align = "center"|5
|align = "center"|9
|align = "center"|10
|align = "center"|13
|align = "center"|13
|align = "center"|16
|align = "center"|15
|align = "center"|7
|align = "center"|5
|-
|align = "center"|'''Estrogens'''
|align = "center"|35
|align = "center"|25
|align = "center"|33
|align = "center"|27
|align = "center"|17
|align = "center"|12
|align = "center"|8
|align = "center"|5
|align = "center"|3
|-
|align = "center"|'''SERMs'''
|align = "center"|0
|align = "center"|0
|align = "center"|0
|align = "center"|0
|align = "center"|0
|align = "center"|9
|align = "center"|14
|align = "center"|12
|align = "center"|12
|-
|}
==Clinical Trials==
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|align = "center" bgcolor = "#FFFF99"|'''Trial No.'''
|align = "center" bgcolor = "#FFFF99"|'''Condition'''
|bgcolor = "#FFFF99"|'''Description'''
|align = "center" bgcolor = "#FFFF99"|'''Intervention'''
|align = "center" bgcolor = "#FFFF99"|'''Therapy'''
|align = "center" bgcolor = "#FFFF99"|'''Route of admn'''
|align = "center" bgcolor = "#FFFF99"|'''Sponsors & Collaborators'''
|align = "center" bgcolor = "#FFFF99"|'''Phase'''
|align = "center" bgcolor = "#FFFF99"|'''Date'''
|-
|align = "center"|1
|align = "center"|Postmenopausal Osteoporosis
|[http://clinicaltrials.gov/ct/show/NCT00405392?order=13 Investigate Patient Preference On Dosing In Ibandronate And Risedronate in korean women ]
|align = "center"| Ibandronate
|align = "center"| Drug
|align = "center"|Oral
|align = "center"| GlaxoSmithKline
|align = "center"|Phase IV
|align = "center"|May-07
|-
|align = "center"|2
|align = "center"|Osteoporosis Osteopenia
|[http://clinicaltrials.gov/ct/show/NCT00145977?order=14 Texture Analysis for Postmenopausal Osteoporosis]
|align = "center"|Alendronate
|align = "center"|Drug
|align = "center"|Oral
|align = "center"|University of Chicago
|align = "center"| -
|align = "center"|Mar-07
|-
|align = "center"|3
|align = "center"|Osteoporosis
|align = "center"|[http://clinicaltrials.gov/ct/show/NCT00471237?order=18 A Phase II Study Evaluating SB-751689 in Post-Menopausal Women With Osteoporosis.]
|align = "center"|SB-751689
|align = "center"|Drug
|align = "center"|Oral
|align = "center"| GlaxoSmithKline
|align = "center"|Phase II
|align = "center"|May-07
|-
|align = "center"|4
|align = "center"|Osteoporosis
|[http://clinicaltrials.gov/ct/show/NCT00432692?order=15 Fall prevention program ]
|align = "center"|Procedure
| -
| -
|align = "center"|Sint Maartenskliniek ZonMw: The Netherlands Organisation for Health Research and Development
|align = "center"|
|align = "center"|Apr-07
|-
|align = "center"|5
|align = "center"|Osteoporosis Osteopenia
|[http://clinicaltrials.gov/ct/show/NCT00491920?order=16 High Dosage Vitamin D and Osteoporosis]
|align = "center"|Cholecalciferol
|align = "center"|Drug
|align = "center"|Oral
|align = "center"|University Hospital of North Norway
|align = "center"|Phase IV
|align = "center"|Jun-07
|-
|align = "center"|6
|align = "center"|Osteoporosis
|[http://clinicaltrials.gov/ct/show/NCT00479037?order=19 Effect of PTH(1-84)or Strontium Ranelate on Bone Formation Measured by Bone Markers]
|align = "center"|Parathyronine hormone
|align = "center"|Drug
|align = "center"|Oral
|align = "center"|Nycomed
|align = "center"|Phase IV
|align = "center"|May-07
|-
|align = "center"|7
|align = "center"|Post-Menopausal Osteoporosis
|[http://clinicaltrials.gov/ct/show/NCT00493532?order=20 A Study of Quarterly Intravenous Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis.]
|align = "center"|ibandronate <nowiki>[</nowiki>Bonviva/Boniva<nowiki>]</nowiki>
|align = "center"|Drug
|align = "center"|Intravenous
|align = "center"|Hoffmann-La Roche
|align = "center"|Phase IV
|align = "center"|Jul-07
|-
|align = "center"|8
|align = "center"|Osteoporosis
|[http://clinicaltrials.gov/ct/show/NCT00414973?order=22 A Study for Patients With Osteoporosis]
|align = "center"|1.Salmon Calcitonin 2.Teriparatide
|align = "center"|Drug
|align = "center"|Nose/intravenous
|align = "center"|Eli Lilly and Company
|align = "center"| Phase III
|align = "center"|Jun-07
|-
|align = "center"|9
|align = "center"|Osteoporosis
|[http://clinicaltrials.gov/ct/show/NCT00404820?order=24 Safety/Efficacy of Zoledronic Acid and Alendronate on Bone Metabolism in Post Menopausal Women With Osteoporosis]
|align = "center"|Zoledronic acid and alendronate
|align = "center"|Drug
|align = "center"|Oral
|align = "center"|Novartis
|align = "center"| Phase III
|align = "center"|May-07
|-
|align = "center"|10
|align = "center"|Osteoporosis
|[http://clinicaltrials.gov/ct/show/NCT00439647?order=26 Efficacy in Reducing Fractures and Safety of Zoledronic Acid in Men With Osteoporosis]
|align = "center"|zoledronic acid
|align = "center"|Drug
|align = "center"|Intravenous
|align = "center"|Novartis
|align = "center"| Phase III
|align = "center"|Feb-07
|-
|align = "center"|11
|align = "center"|Osteoporosis
|[http://clinicaltrials.gov/ct/show/NCT00154609?order=27 Davallia Divaricata BL: The Use of Traditional Chinese Native Medicine for Osteoporosis]
|align = "center"|Gu-Sui-Bu (Davallia Divaricata)
|align = "center"|Drug
|align = "center"|
|align = "center"|National Taiwan University Hospital
|align = "center"| Phase I
|align = "center"|Jan-07
|-
|align = "center"|12
|align = "center"|Osteoporosis
|[http://clinicaltrials.gov/ct/show/NCT00489918?order=44 Dose Ranging Study - Macroflux PTH in Postmenopausal Women With Osteoporosis]
|align = "center"|Macroflux PTH
|align = "center"|Drug
|align = "center"|Subcutaneuos
|align = "center"|The Macroflux Corporation
|align = "center"|Phase II
|align = "center"|Jun-07
|-
|align = "center"|13
|align = "center"|Osteoporosis
|[http://clinicaltrials.gov/ct/show/NCT00391404?order=41 Fosamax for Childhood Cancer Survivors]
|align = "center"|Alendronate
|align = "center"|Drug
|align = "center"|Oral
|align = "center"|Chinese University of Hong Kong
|align = "center"| Phase III
|align = "center"|Oct-06
|-
|align = "center"|14
|align = "center"|Osteoporosis
|[http://clinicaltrials.gov/ct/show/NCT00365456?order=40 This study is currently recruiting patients.]
|align = "center"|Parathyroid Hormone (PTH)
|align = "center"|Drug
|align = "center"|Subcutaneuos
|align = "center"| Nycomed
|align = "center"| -
|align = "center"|Feb-07
|-
|align = "center"|15
|align = "center"|Osteoporosis
|[http://clinicaltrials.gov/ct/show/NCT00421343?order=38 This study is currently recruiting patients.]
|align = "center"|Alendronate with cholecalciferol and Os-Cal with extra D
|align = "center"|Drug
|align = "center"|Oral
|align = "center"|National Institute on Aging (NIA),Glaxosmithkline
|align = "center"|Phase III
|align = "center"|May-07
|-
|align = "center"|16
|align = "center"|Primary Osteoporosis
|[http://clinicaltrials.gov/ct/show/NCT00447915?order=32 Phase II/III Clinical Study of R484iv (Ibandronic Acid) for Primary Osteoporosis]
|align = "center"|Ibandronic acid
|align = "center"|Drug
|align = "center"|Oral
|align = "center"| Chugai Pharmaceutical
|align = "center"|Phase III
|align = "center"|Mar-07
|-
|align = "center"|17
|align = "center"|Postmenopausal Osteoporosis, Back pain and Spinal Fracture
|[http://clinicaltrials.gov/ct/show/NCT00343252?order=37 Effect of Teriparatide Compared to Risedronate on Back Pain in Women With a Spine Fracture Caused by Osteoporosis]
|Teriparatide and risedronate
|align = "center"|Drug
|align = "center"|Oral/Subcutaneuos
|align = "center"|Eli Lilly and Company
|align = "center"|Phase III
|align = "center"|Jul-07
|-
|align = "center"|18
|align = "center"|Osteoporosis
|align = "center"|[http://clinicaltrials.gov/ct/show/NCT00493623?order=50 BONDIR Study: A Study of Intravenous Bonviva (Ibandronate) After Recent Vertebral Osteoporotic Fracture in Patients With Osteoporosis.]
|align = "center"|Ibandronate <nowiki>[</nowiki>Bonviva/Boniva<nowiki>]</nowiki>
|align = "center"|Drug
|align = "center"|Intravenous
|align = "center"|Hoffmann-La Roche
|align = "center"|Phase III
|align = "center"|Jul-07
|-
|}

==Intellectual Property==
===Search strategy===
* '''Database/Vendor''': Micropat
* '''Search scope''': US Granted US Applications EP-A EP-B WO JP (bibliographic data only) DE-C,B DE-A DE-T DE-U GB-A FR-A; '''Claims'''
* '''Years''': Issue/Publication Date: >20051231
* '''Search String''': ((Osteoporosis OR (bone Near3 regeneration)) AND (treatment))
* '''Hits''': 1261/982 patents (with/with out family members)
* '''Date of search''': 14th September 2007

===Top players and IPC classes===

[[Image:Top players and IPC.jpeg|center|800 px|]]

===Geographical Distribution and Treatment Approaches===
[[Image:Osteoporosis -geographical.jpeg|center|800 px|]]

===IP activity and Treatment Approaches===
* Decline in the IP activity during 2006 and 2007 is due 18 months publication delay of patent document.
[[Image:Osteoporosis -year approach.jpeg|center|800 px|]]

==Conferences==
[http://www.chinamed.com.cn/icobr2008/html/WelcomeAddress.html International Conference on Osteoporosis and Bone Research to be held on Oct 15-18, 2008 in Beijing, China.]

[http://www.iofbonehealth.org/wco/2008/homepage.html 2008 IOF World Congress on Osteoporosis to be held on December 2-7, 2008 in Bangkok, Thailand]

[http://www.oarsi.org/meetings/07Congress/index.cfm 2007 World Congress on Osteoarthritis, being held December 6 - 9, 2007 at the Marriott Harbor Beach Resort & Spa in fabulous Ft. Lauderdale, Florida!]

File:Product-map.jpg

2007-10-16T10:37:15Z

Rajiv:

File:Product map.jpg

2007-10-16T10:35:45Z

Rajiv:

Oral Diabetes Drugs

2007-10-16T10:34:24Z

Rajiv: /* Product Pathways */

Diabetes is a disease caused by high levels of blood glucose resulting from improper production of insulin or action of insulin.

* '''Type 1''': In this Diabetes, the cells that make the hormone insulin regulate the blood glucose are destroyed by the body immune system. This is also called as juvenile onset diabetes as it occurs mainly in children and young adults. 5%-10% of all the cases of diabetes have Type I diabetes. Clinical trials are being pursued and planned to prevent type I diabetes. This is also called as Insulin Dependent Diabetes Mellitus (IDDM).
* '''Type 2''': In this case, either the cells do not use insulin properly or the body does not produce enough insulin. 90% - 95% of the diabetics have Type 2 diabetes. This type of disease is also called as non-insulin dependent diabetes mellitus (NIDDM) and is mainly observed in people with old age, obese, family history of diabetes, history of gestational diabetes, impaired glucose metabolism, physical inactivity and race/ethnicity.
* '''Gestational Diabetes''': Increase in the levels of blood sugar during pregnancy is called gestational diabetes.

==Incidence and prevalence==
===Incidence===
In year 2004, diabetes ( Both type I and type II ) was diagnosed in 1.4 million adults between the age of 18-79 years (Figure 1). The incidence of diabetes was lower in adults having an age between 18-44 years compared to other groups (Figure 2). From 1997 through 2004, the age adjusted incidence of diagnosed diabetes ( Both type I and type II )increased by 35% among men and 46% among women (Figure 3).

[[Image:Number in thousands vs Year.jpg|left|250 px|thumb|Figure 1. Annual number (in thousands) of new cases of diagnosed diabetes among adults aged 18-79 years, in United States from 1997-2004. [http://www.cdc.gov/diabetes/statistics/incidence/fig1.htm Source]]]

[[Image: Rate per 1000 vs gender.gif|right|250 px|thumb|
Figure 3. Gender based incidence of diagnosed diabetes per 1000 population aged from 18-79 years in U.S. [http://www.cdc.gov/diabetes/statistics/incidence/fig4.htm Source]]]

[[Image: Rate per 1000 vs Year.jpg|center|250 px|thumb|Figure 2. Incidence of diagnosed diabetes per 1000 population aged 18-79 years, by age in U.S from 1997 to 2004. [http://www.cdc.gov/diabetes/statistics/incidence/fig3.htm Source]]].

*The following table attempts to extrapolate the incidence rate for Diabetes( both type I and type II ) to the populations of various countries and regions.[http://cureresearch.com/d/diabetes/stats-country.htm Cure reasearch, Statistics by Country for Diabetes]
{|border="2" cellspacing="0" cellpadding="4" width="86%"
|align = "center" bgcolor = "#FFFF00"|''' S.NO'''
|bgcolor = "#FFFF00"|'''Country/Region'''
|bgcolor = "#FFFF00"|'''Extrapolated incidence'''
|-
|align = "center"|1
| USA
|861,533
|-
|align = "center"|2
|Canada
|95,372
|-
|align = "center"|3
|Europe
|1,474,002
|-
|align = "center"|4
|Asia
|10,063,645
|-
|align = "center"|5
|Africa
|1,290,255
|-
|align = "center"|6
|Middle east
|1,055,809
|-
|align = "center"|7
|Australia and Southern Pacific
|70,138
|-
|}

===Prevalence===
The prevalence of diabetes( Both type I and type II ) in U.S. during the years 1980 to 2005, increased from 5.6 million to 15.8 million (Figure 4). Especially people aged from 65 to 74 had the highest prevalence compared to other age groups (Figure 5). The prevalence of the disease was similar in both men and women till the year 1998 but from 1999, the prevalence of the disease increased highly in men compared to females (Figure 6).

[[Image:Number vs Year.jpg|left|250 px|thumb|Figure 4. Number (millions) of persons with diagnosed diabetes from year 1980 to 2005 in United States. [http://www.cdc.gov/diabetes/statistics/prev/national/figpersons.htm Source]]]

[[Image:Rate_per_100_vs_Age.jpg|right|250 px|thumb|Figure 5. Age dependent Prevalence of diagnosed diabetes in United States from year 1980 to 2005. [http://www.cdc.gov/diabetes/statistics/prev/national/figbyage.htm Source]]]

[[Image:Rate per 100 vs Year.jpg|center|250 px|thumb|Figure 6. Gender dependent Prevalence of diagnosed diabetes in United States from year 1980 to 2005. [http://www.cdc.gov/diabetes/statistics/prev/national/figbysex.htm Source]]].
*The following table attempts to extrapolate the prevalence rate for Diabetes( both type I and type II ) to the populations of various countries and regions.[http://cureresearch.com/d/diabetes/stats-country.htm Cure reasearch, Statistics by Country for Diabetes].
{|border="2" cellspacing="0" cellpadding="4" width="86%"
|align = "center" bgcolor = "#FFFF00"|''' S.NO'''
|bgcolor = "#FFFF00"|'''Country/Region'''
|bgcolor = "#FFFF00"|'''Extrapolated Prevalence'''
|-
|align = "center"|1
| USA
|17,273,847
|-
|align = "center"|2
|Canada
|1,912,227
|-
|align = "center"|3
|Europe
|33,882,009
|-
|align = "center"|4
|Asia
|201,777,550
|-
|align = "center"|5
|Africa
|25,393,535
|-
|align = "center"|6
|Middle east
|21,169,243
|-
|align = "center"|7
|Australia and Southern Pacific
|1,406,291
|-
|}

==Market Overview==
* The Insulin market in 2006 was largely dominated by two players, Novo Nordisk of Denmark and Eli Lilly of USA.
* India and China are emerging as the most potential future markets for insulin delivery devices.
* Growing at a CAGR of 14.09%, global insulin market will reach US$ 14.5 Billion by 2010 from US$ 7.5 Billion in 2005.
* Over 60% of the insulin sold in 2006 was sold in pen devices.
* Insulin pen devices dominate the market in Europe and Japan whereas syringes and pumps dominate the US market.
* There was a big improvement in the global diabetes market for innovation particularly in the field of non-invasive methods of insulin delivery, including inhalable, oral and patch technology. [http://www.marketresearch.com/product/display.asp?productid=1491639&g=1 Source]
* There are 3 key new OAD classes; PPAR agonists, GLP-1 agonists/DPP IV inhibitors, and amlinomimetic agents. High forecasted sales are anticipated in 2011 for the GLP-1 agonist Exenatide LAR and the DPP-IV inhibitor Galvus at $2,902.9m and $1,228.7m, respectively. [http://www.marketresearch.com/product/display.asp?productid=1286835&g=1 Source]

[[Image:Diabetic market data.jpeg|thumb|center|800 px|]]

A. [http://www.globalbusinessinsights.com/content/rbhc0159m.pdf Competitive dynamics of the leading players in the global diabetes market, 2005]
B. [http://www.globalbusinessinsights.com/content/rbhc0159m.pdf Global diabetes market share by geography, 2005]]
C. [http://www.bccresearch.com/editors/RB-158.html Worldwide Diabetes Market, 2000, 2001, 2002 and 2007]
D. [http://www.globalbusinessinsights.com/content/rbhc0126m.PDF Global* market share of leading insulins (%), 1999-2003]

==Product Information==

[[Image:diabetes4.jpg|800 px|center|thumb| Overall categorization of diabetes treatments]]

===Products: Oral Hypoglycemic Agents===
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|bgcolor = "#FFFF00" colspan = "4"|Oral Hypoglycemic Agents
|-
|bgcolor = "#CCFFFF"|'''Drug'''
|bgcolor = "#CCFFFF"|'''Brand'''
|bgcolor = "#CCFFFF"|'''Company'''
|bgcolor = "#CCFFFF"|'''Availability'''
|-
|colspan = "4" | '''Sulfonylureas'''
|-
|'''First Generation'''
| 
| 
| 
|-
|Acetohexomide
|Dymelor
|Eli Lilly
|US, F, G, I, S,UK, J
|-
|Chlorpropamide, Tolazamide
|Diabenase
|Pfizer
|US, F, G, I, S,UK, J
|-
|'''Second Generation'''
| 
| 
| 
|-
|Glyburide (Glibenclamide)
|Diabeta
|Aventis
|US, F, G, I, S,UK, J
|-
|Glyburide (Glibenclamide)
|Micronase
|Pharmacia
|US, F, G, I, S,UK, J
|-
|Glyburide (Glibenclamide)
|Glynase
|Pharmacia
|US, F, G, I, S,UK, J
|-
|Glypizide
|Glucotrol, Glucotrol XL
|Pfizer
|US, F, G, I, S,UK, J
|-
|'''Third Generation'''
| 
| 
| 
|-
|Glimepride
|Amaryl
|Aventis
|US, F, G, I, S,UK, J
|-
|colspan = "4" |'''Meglitnides'''
|-
|Repaglinide
|Prandin
|Novo Nordisk
|US, F, G, I, S,UK, J
|-
|Nateglinide
|Sralix
|Novartis
|US,UK, J
|-
|colspan = "4" |'''Biguanides'''
|-
|Metfromin
|Glucophage, Glucophage XR
|Bristol-Myers Squibb
|US
|-
|Metfromin
| 
| 
| 
|-
|colspan = "4" |'''Thiazolidinediones'''
|-
|Rosiglitazone
|Avandia
|Glaxosmithkline
|US, G, UK
|-
|Pioglitazone
|Actos
|Takeda/ Eli Lilly
|US, UK, G, S, J
|-
|colspan = "4" |'''Alfa-Glucosidase Inhibitors'''
|-
|Acarbose
|Precose
|Bayer
|US, F, G, I, S,UK, J
|-
|Miglitol
|Glyset
|Pharmacia
|US, F, G, S
|-
|Voglibose
|Basen, Volix, Vogseal
|Ranbaxy, Nihon Pharmaceutical Industry Ltd
|I, J
|-
|colspan = "4"|'''Dipeptidyl peptidase-4 (DPP-4) inhibitor'''
|-
|Sitgliptin
|Januvia
|Merck
|US
|-
|}

===Products: Fixed Drug Combinations===
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|align = "center" colspan = "4"|'''Fixed Drug Combinations'''
|-
|bgcolor = "#CCFFFF"|'''Brand Name'''
|bgcolor = "#CCFFFF"|'''Drug 1'''
|bgcolor = "#CCFFFF"|'''Drug 2'''
|bgcolor = "#CCFFFF"|'''Company'''
|-
|Metaglip
|Glipizide
|Metformin
|Bristol-Myers Squibb
|-
|Duetact
|Glimepiride
|Pioglitazone
|Takeda
|-
|Avandaryl
|Glimepiride
|Rosiglitazone
|GlaxoSmithKline
|-
|ACTOSPlusMet
|Pioglitazone
|Metformin
|Takeda
|-
|Avandamet
|Rosiglitazone
|Metformin
|GlaxoSmithKline
|-
|Janumet
|Sitgliptin
|Metformin
|Merck
|-
|}

===Product pipeline===

[[Image:Roche.jpg|thumb|center|600px|]]
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|align = "center" bgcolor = "#FFFF99" colspan = "3" |'''Product Pipeline'''
|-
|align = "center" bgcolor = "#FFCC99"|'''Drug'''
|align = "center" bgcolor = "#FFCC99"|'''Company'''
|align = "center" bgcolor = "#FFCC99"|'''Stage'''

|-
|align = "center" colspan = "3"|'''Dipeptidyl Peptidase IV (DPP-IV) Inhibitor ''':DPP-IV inactivates glucagon-like peptide-1 (GLP-1), an important mediator of blood glucose levels following meals. DPP-IV inhibitors have been clinically shown to provide long term improvement of glucose control without the risk of hypoglycemia, and to improve the function of pancreatic beta cells, the cells responsible for the production of insulin.

|-
|align = "center"|ALS 2-0426
|align = "center"|[http://www.amgen.com/investors/pipe.jsp Alantos Pharmaceuticals, Amgen, Servier]
|align = "center"|1

|-
|align = "center"|PSN9301
|align = "center"|[http://www.osip.com/PSN9301 OSI]
|align = "center"|2

|-
|align = "center"|SYR-322
|align = "center"|[http://findarticles.com/p/articles/mi_m0RSB/is_2006_Jan_21/ai_n16017480 Takeda]
|align = "center"|3

|-
|align = "center"|R1579
|align = "center"|[http://www.roche.com/home/investors/inv_pipeline/inv_pipeline_det.htm?ta=Metabolism&Phase=%25&submit=Show+pipeline Roche]
|align = "center"|1

|-
|align = "center"|vildagliptin (Galvus)
|align = "center"|[http://www.pharma.us.novartis.com/newsroom/pressReleases/releaseDetail.jsp?PRID=1984 novartis]
|align = "center"|NDA submitted in March 2006

|-
|align = "center"|MP-513
|align = "center"|[http://www.m-pharma.co.jp/cgi-bin/pageview.cgi?pass=/e/develop/situation.html Mitsubishi Pharma]
|align = "center"|2

|-
|align = "center"|Gastrin <nowiki>+</nowiki> DPP IV Inhibitor
|align = "center"|[http://www.transitiontherapeutics.com/technology/index.php Transition Therapeutics]
|align = "center"|Preclinical

|-
|align = "center"|Saxagliptin
|align = "center"|[http://www.bms.com/research/content/data/pipeline.html Otsuka Pharmaceutical Co, Bristol-Myers Squibb]
|align = "center"|3

|-
|colspan = "3"|'''Insulin sensitizer'''

|-
|align = "center"|ISIS 113715
|align = "center"|[http://www.isispharm.com/product_pipeline.html Isis]
|align = "center"|3

|-
|align = "center"|NCX 4016 (Nitric Oxide donating derivative of Acetyl Salicylic acid)
|align = "center"|[http://www.nicox.com/update/NCX_4016.html NicOx]
|align = "center"|2

|-
|align = "center"|DG070 inhibitors
|align = "center"|[http://www.develogen.com/en/prod_pipeline.php?hnav=2&tnav=0 Develogen AG]
|align = "center"|Preclinical

|-
|align = "center"|NovoNorm® (repaglinide)/Metformin
|align = "center"|[http://www.novonordisk.com/science/pipeline/rd_pipeline.asp?showid=6 Novo Nordisk]
|align = "center"|3

|-
|colspan = "3"|'''Biguanides'''
|-
|-

|-
|align = "center"|Gastrin <nowiki>+</nowiki> Metformin
|align = "center"|[http://www.transitiontherapeutics.com/technology/index.php Transition Therapeutics]
|align = "center"|1

|-
|colspan = "3"|'''GLP 1 Analogue / Agonists''' GLP 1 Analogues have to be injected subcutaneously, Emisphere is working on an oral analogue

|-
|align = "center"|Abiglutide (716155)
|align = "center"|[http://www.gsk.com/investors/product_pipeline/docs/pipeline.pdf glaxosmithkline]
|align = "center"|2
|-
|align = "center"|TH0318
|align = "center"|[http://www.drugresearcher.com/news/ng.asp?id=58974-new-diabetic-drug Theratechnolgies]
|align = "center"|1

|-
|align = "center"|Liraglutide (NN2211)
|align = "center"|[http://www.novonordisk.com/science/pipeline/rd_pipeline.asp?showid=4 Novo Nordisk]
|align = "center"|3

|-
|align = "center"|R1583
|align = "center"|[http://www.roche.com/home/investors/inv_pipeline/inv_pipeline_det.htm?ta=Metabolism&Phase=%25&submit=Show+pipeline Roche]
|align = "center"|2

|-
|align = "center"|Oral GLP
|align = "center"|[http://www.emisphere.com/product_pipeline.asp Emisphere Technologies]
|align = "center"|1

|-
|align = "center"|PC-DAC™:Exendin-4
|align = "center"|[http://conjuchem.hyphenhealth.com/ ConjuChem]
|align = "center"|2

|-
| 
|align = "center"|[http://www.bms.com/research/content/data/pipeline.html Bristol-Myers Squibb ]
|align = "center"|Exploratory development

|-
|align = "center"|AVE0001A
|align = "center"|[http://en.sanofi-aventis.com/rd/portfolio/p_rd_portfolio_metabo.asp Sanofi Aventis]
|align = "center"|2

|-
|align = "center"|Gastrin <nowiki>+</nowiki>GLP 1 Agonist
|align = "center"|[http://www.transitiontherapeutics.com/technology/index.php Transition Therapeutics]
|align = "center"|2

|-
|colspan = "3"|'''Peroxisome Proliferator-Activated Receptor (PPAR) agonist/analogue'''

|-
|align = "center"|CS-011 (Rivoglitazone)
|align = "center"|Sankyo
|align = "center"|2

|-
|align = "center"|Metaglidasen(MBX 102)
|align = "center"|[http://www.medicalnewstoday.com/articles/26017.php Metabolex]
|align = "center"|2

|-
|align = "center"|MBX-2044
|align = "center"|[http://www.metabolex.com/pipeline.html Metabolex]
|align = "center"|1

|-
|align = "center"|AVE8134
|align = "center"|[http://en.sanofi-aventis.com/rd/portfolio/p_rd_portfolio_metabo.asp Sanofi Aventis]
|align = "center"|2

|-
|align = "center"|AVE0897
|align = "center"|[http://en.sanofi-aventis.com/rd/portfolio/p_rd_portfolio_metabo.asp Sanofi Aventis]
|align = "center"|1

|-
|align = "center"|R1439, aleglitazar
|align = "center"|[http://www.roche.com/home/investors/inv_pipeline/inv_pipeline_det.htm?ta=Metabolism&Phase=%25&submit=Show+pipeline Roche]
|align = "center"|2

|-
|align = "center"|AVE0847
|align = "center"|[http://en.sanofi-aventis.com/rd/portfolio/p_rd_portfolio_metabo.asp Sanofi Aventis]
|align = "center"|2

|-
|align = "center"|SAR351034
|align = "center"|[http://en.sanofi-aventis.com/rd/portfolio/p_rd_portfolio_metabo.asp Sanofi Aventis]
|align = "center"|Preclinical

|-
|align = "center"|376501
|align = "center"|[http://www.gsk.com/investors/pp_pipeline_standard.htm Glaxosmithkline]
|align = "center"|1

|-
|align = "center"|625019
|align = "center"|[http://www.gsk.com/investors/pp_pipeline_standard.htm Glaxosmithkline]
|align = "center"|1

|-
|align = "center"|677954
|align = "center"|[http://www.gsk.com/investors/pp_pipeline_standard.htm Glaxosmithkline]
|align = "center"|2

|-
|align = "center"|Avandia
|align = "center"|[http://www.gsk.com/investors/pp_pipeline_standard.htm Glaxosmithkline]
|align = "center"|2

|-
|align = "center"|Avandia XR
|align = "center"|[http://www.gsk.com/investors/pp_pipeline_standard.htm Glaxosmithkline]
|align = "center"|2

|-
|align = "center"|PPAR Gamma Agonist <nowiki>+</nowiki> simvaststin
|align = "center"|[http://www.gsk.com/investors/pp_pipeline_standard.htm Glaxosmithkline]
|align = "center"|3

|-
|align = "center"|MCC-555, Netoglitazone
|align = "center"|[http://www.m-pharma.co.jp/cgi-bin/pageview.cgi?pass=/e/develop/situation.html Mitsubishi Pharma, Novartis]
|align = "center"| 

|-
|align = "center"|Muraglitzar
|align = "center"|[http://www.drugs.com/nda/muraglitazar_041223.html Bristol-Myers Squibb ]
|align = "center"|3

|-
|align = "center"|R483
|align = "center"|[http://www.roche.com/pages/downloads/investor/pdf/praesentations/irp050504rdd14.pdf Roche]
|align = "center"|2

|-
|align = "center"|PPM-204
|align = "center"|[http://www.wyeth.com/research/pipeline Wyeth], [http://www.invitrogen.com/downloads/Discovery_Inhibitor_Oncogenic_B-RAF.pdf Plexxikon]
|align = "center"|2

|-
|colspan = "3"|'''Oral glucokinase activator (GKA)'''

|-
|align = "center"|PSN010
|align = "center"|[http://www.osip.com/PSN010 OSI]
|align = "center"|1

|-
|align = "center"|R1511
|align = "center"|[http://www.roche.com/home/investors/inv_pipeline/inv_pipeline_det.htm?ta=Metabolism&Phase=%25&submit=Show+pipeline Roche]
|align = "center"|1

|-
|colspan = "3"|'''G protein-coupled Receptor(GPR) 119 Agonist'''

|-
|align = "center"|PSN821
|align = "center"|[http://www.osip.com/PSN010 OSI]
|align = "center"| 

|-
|colspan = "3"|'''Antisense drug for Glucagon Receptor (GCGR)'''

|-
|align = "center"|ISIS 325568
|align = "center"|[http://www.isispharm.com/product_pipeline.html Isis]
|align = "center"|1

|-
|colspan = "3"|'''Antisense drug for Glucocorticoid Receptor (GCCR)'''

|-
|align = "center"|ISIS 377131
|align = "center"|[http://www.isispharm.com/product_pipeline.html Isis]
|align = "center"|Preclinical

|-
|colspan = "3"|''' Sodium Glucose Transporter 2 (SGLT2) inhibitor'''

|-
|align = "center"|AVE2268
|align = "center"|[http://en.sanofi-aventis.com/rd/portfolio/p_rd_portfolio_metabo.asp Sanofi Aventis]
|align = "center"|2

|-
|align = "center"|SAR 7226
|align = "center"|[http://en.sanofi-aventis.com/rd/portfolio/p_rd_portfolio_metabo.asp Sanofi Aventis]
|align = "center"|Preclinical

|-
|align = "center"|189075
|align = "center"|[http://www.gsk.com/investors/product_pipeline/docs/pipeline.pdf Glaxosmithkline]
|align = "center"|2

|-
|align = "center"|869682
|align = "center"|[http://www.gsk.com/investors/product_pipeline/docs/pipeline.pdf Glaxosmithkline]
|align = "center"|2

|-
|colspan = "3"|'''Growth hormone releasing analogue'''

|-
|align = "center"|TH 9507
|align = "center"|[http://www.theratech.com/en/products-therapeutic-peptides/pipeline.php Theratechnolgies]
|align = "center"| 

|-
|colspan = "3"|'''Nitric oxide (NO) blocking agent'''

|-
|align = "center"|NOX-700
|align = "center"|[http://www.medinox.com/news/press.htm Medinox]
|align = "center"|1 staretd in 2002

|-
|colspan = "3"|'''Antibody'''

|-
|align = "center"|TRX4
|align = "center"|[http://www.btgplc.com/PartneredDevelopment/240/TRX4.html BTG]
|align = "center"|2

|-
|colspan = "3"|'''Selective inhibitor of fructose-1, 6-bisphosphatase (FBPase)'''
|-
|align = "center"|CS-917
|align = "center"|[http://www.mbasis.com/pipeline/metabolic_disease.html Sankyo,Metabasis]
|align = "center"|2

|-
|align = "center"|MB07803
|align = "center"|[http://www.mbasis.com/pipeline/index.html metabasis, Daiichi Sankyo]
|align = "center"|2

|-
|colspan = "3"|'''11-beta hydroxysteroid dehydrogenase type 1 (11ß-HSD1) inhibitor'''

|-
|align = "center"|AMG 221
|align = "center"|[http://wwwext.amgen.com/science/pipe_AMG221.html Amgen, Biovitrum]
|align = "center"|1

|-
|colspan = "3"|'''Polypyrimidine tract binding protein (PTB, also named hnRNP) inhibitor'''

|-
|align = "center"| 
|align = "center"|Serono
|align = "center"|1
|-
|colspan = "3"|'''Insulin Like Growth Factor 1'''
|-
|-
|align = "center"|IPLEX (Mecasermin rinfabate)
|align = "center"|Glen Allen
|align = "center"|Orphan Drug Status

|-
|colspan = "3"|'''Newer Meglitinides'''
|-
|-
|align = "center"|Nateglinide with insulin sensitizers
|align = "center"|[http://www.astellas.com/global/about/news/2006/pdf/061130_eg.pdf Astellas pharmas]
|align = "center"|SNDA Filed

|-
|align = "center"|Nateglinide with biguanides
|align = "center"|[http://www.astellas.com/global/about/news/2006/pdf/061130_eg.pdf Astellas pharmas]
|align = "center"|SNDA Filed

|-
|colspan = "3"|'''Islet Regeneration Factors'''
|-
|-
|-
|align = "center"|DG770 (beta cell regeneration factor)
|align = "center"|[http://www.develogen.com/en/prod_pipeline.php?hnav=2&tnav=0 Develogen AG]
|align = "center"|3

|-
|align = "center"|E1 INT (Islet regeneration)
|align = "center"|[http://www.transitiontherapeutics.com/technology/index.php Transition Therapeutics]
|align = "center"|2

|-
|bgcolor = "#FFFF99" colspan = "3"|'''Miscellaneous'''

|-
|align = "center"|AMG 837 (Potentiates Glucose Dependent Insulin Secretion)
|align = "center"|[http://www.amgen.com/science/pipe_amg837.html Amgen]
|align = "center"|1

|-
|align = "center"|MBX 213
|align = "center"|[http://www.metabolex.com/pipeline.html Metabolex]
|align = "center"|1

|-
|align = "center"|R 1499
|align = "center"|[http://www.roche.com/pages/downloads/investor/pdf/praesentations/irp050504rdd14.pdf Roche]
|align = "center"|1

|-
|align = "center"|R1438
|align = "center"|[http://www.roche.com/pages/downloads/investor/pdf/praesentations/irp050504rdd14.pdf Roche]
|align = "center"|2

|-
|align = "center"|R1440
|align = "center"|[http://www.roche.com/pages/downloads/investor/pdf/praesentations/irp050504rdd14.pdf Roche]
|align = "center"|2

|-
|align = "center"|PSN 357
|align = "center"|OSI
|align = "center"|1

|-
|align = "center"|NBI 6024
|align = "center"|Neurocrine Biosciences
|align = "center"|2

|-
|align = "center"|MK 0941
|align = "center"|[http://www.merck.com/finance/pipeline.swf Merck]
|align = "center"|1

|-
|align = "center"|MK 1642
|align = "center"|[http://www.merck.com/finance/pipeline.swf Merck]
|align = "center"|1

|-
|align = "center"|Mk 0533
|align = "center"|[http://www.merck.com/finance/pipeline.swf Merck]
|align = "center"|2

|-
|align = "center"|MK0893
|align = "center"|[http://www.merck.com/finance/pipeline.swf Merck]
|align = "center"|2

|-
|align = "center" bgcolor = "#FFFF99" colspan = "3"|'''Insulins'''

|-
|align = "center"|Oral Insulin
|align = "center"|[http://www.emisphere.com/pc_oi.asp Emisphere Technologies]
|align = "center"|2

|-
|align = "center"|Technosphere
|align = "center"|[http://www.mannkindcorp.com/technosphere_insulin.aspx Mannkind corporation]
|align = "center"|3

|-
|align = "center"|NN344 (Insulin analogue)
|align = "center"|[http://www.novonordisk.com/science/pipeline/rd_pipeline.asp?showid=18 Novo Nordisk]
|align = "center"|1

|-
|align = "center"|NN5401(Insulin analogue)
|align = "center"|[http://www.novonordisk.com/science/pipeline/rd_pipeline.asp?showid=19 Novo Nordisk]
|align = "center"|1

|-
|align = "center"|AERx® iDMS (Insulin Inhalation system)
|align = "center"|[http://www.novonordisk.com/science/pipeline/rd_pipeline.asp?showid=5 Novo Nordisk]
|align = "center"|3

|-
|align = "center"|Inhaled insulin
|align = "center"|Bristol Meyers Squibb
|align = "center"|1

|-
|align = "center"|Inhaled insulin
|align = "center"|[http://investor.lilly.com/pipeline.cfm Eli Lilly]
|align = "center"|2

|-
|align = "center"|Exubera (Inhaled insulin)
|align = "center"|[http://www.pfizer.com/research/cardiovascular_condition.jsp Pfizer]
|align = "center"|4

|-
|align = "center"|Oal Lyn (Inhaled insulin)
|align = "center"|[http://www.generex.com/products/oral-lyn/ http://www.generex.com/products/oral-lyn/]
|align = "center"|Approved in Ecuador

|-
|align = "center"|Nasulin
|align = "center"|[http://www.bentleypharm.com/other/pipeline Bentley]
|align = "center"|2

|}

===Product Pathways===

[[Image:Product_map.jpg|thumb|center|900px| Product]]

[[Image:Product-map.jpg|thumb|center|900px| Product pipeline]]

==Intellectual Property==
===Search strategy===
* '''Database/Vendor:''' Micropat
* '''Search scope:''' US Granted US Applications EP-A EP-B WO JP (bibliographic data only) DE-C,B DE-A DE-T DE-U GB-A FR-A; '''English Title'''
* '''Years:''' '''Issue/Publication Date:''' >20051231
* '''Search String:''' (Diabetes OR diabetic) AND (treatment OR treating)
* '''Hits:''' 618/217 patents (with/with out family members)
* '''Date of search:''' 11 July 2007

===Top players and IPC classes===

[[Image:Diabetes- top players.jpeg|center|800 px|]]

====IPC code definition====

{|border="0" cellspacing="1" width="80%"
|'''A61K'''
|Preparations for medical, dental, or toilet purposes
|-
|'''C07D'''
|Heterocyclic compounds
|-
|'''C07K'''
|Peptides
|-
|'''C12N'''
|Micro-organisms or enzymes; compositions thereof
|-
|'''C12Q'''
|Measuring or testing processes involving enzymes or micro-organisms (immunoassay); compositions or test papers therefor; processes of preparing such compositions; condition-responsive control in microbiological or enzymological processes
|-
|}

===Geographical Distribution and Treatment Approaches===

[[Image:Diabetes -geographical.jpeg|center|800 px|]]

===IP activity and Treatment Approaches===
* Decline in the IP activity during 2005 and 2006 is due 18 months publication delay of patent document.
[[Image:Diabetes -year approach.jpeg|center|800 px|]]

==Clinical Trials==
===Approved/On-going===
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|align = "center" bgcolor = "#FFFF99" colspan = "5"|'''Clinical trials'''
|-
|align = "center"|'''Drug'''
|align = "center"|'''Sponsors'''
|align = "center"|'''Description'''
|align = "center"|'''Phase'''
|align = "center"|'''Date of Start'''
|-
|align = "center" colspan = "5"|'''Oral Drugs'''
|-
|align = "center" colspan = "5"|'''Cannabinoid receptor antagonist'''
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00478595?order=1 Rimonabant]
|align = "justify"|Sanofi-Aventis
|align = "justify"|The primary objective of this study is to assess the efficacy of SR141716 (rimonabant) compared to placebo on change in HbA1c and on relative change in body weight over 52 weeks in obese type 2 diabetic patients on monotherapy inadequately controlled with oral anti-diabetic drug (sulfonylurea or ?-glucosidase inhibitor).
|align = "center"|3
|align = "center"|May-07
|-
|align = "center" colspan = "5"|'''Insulin Sensitisers'''
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00353587?order=24 Metaglidasen]
|align = "justify"|Metabolex
|align = "justify"|
|align = "center"|2, 3
|align = "center"|May-06
|-
|align = "center" colspan = "5"|'''Thioglitazone'''
|-
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00386100?order=1 Rosiglitazone maleate/metformin hydrochloride (AVANDAMET)]
|align = "justify"|GlaxoSmithKline
|align = "justify"|This study will evaluate the longer-term glycemic effect of two medicines approved for initial treatment of type 2 diabetes.
|align = "center"|4
|align = "center"|Oct-06
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00515632?order=8 Balaglitazone]
|align = "justify"|Rheoscience A/S
|align = "justify"|Balaglitazone is a thiazolidinedione derivative that is being developed as an oral anti-diabetic drug to improve blood glucose control in patients with type 2 diabetes. The purpose of this study is to assess if additional treatment with balaglitazone in patients with type 2 diabetes on stable insulin treatment will improve blood glucose control and decrease the daily insulin dose, but with less impact on weight gain and oedema.
|align = "center"|3
|align = "center"|Jul-07
|-
|align = "center" colspan = "5"|'''(DPP-4) inhibitor'''
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00351884?order=18 Vildagliptin]
|align = "justify"|Novartis
|align = "justify"|This is a 24-week study to assess the efficacy on HbA1c of 100 mg vildagliptin once daily as compared to placebo as add-on to metformin in patients with type 2 diabetes inadequately controllled with metformin.
|align = "center"|3
|align = "center"|May-06
|-
|align = "center" colspan = "5"|'''Insulin'''
|-
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00419562?order=1 Oral Insulin]
|align = "justify"|NIDDK, NICHD, NIAID, NICR, ADA, JDRF
|align = "justify"|N/A
|align = "center"|3
|align = "center"|Feb-07
|-
|align = "center" colspan = "5"|'''Potassium Channel Blocker'''
|-
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00131755?order=1 Diazoxide]
|align = "justify"|Grill, Valdemar, M.D.
|align = "justify"|The purpose of this study is to find out if Diazoxide can partly retain insulin production in newly diagnosed type 1 diabetes patients.
|align = "center"|4
|align = "center"|Feb-05
|-
|align = "center" colspan = "5"|'''Nutritional Agents'''
|-
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00117026?order=1 Benfotiamine (Vitamin B1)]
|align = "justify"|University Hospital, Aker, The Research Council of Norway
|align = "justify"|N/A
|align = "center"|1, 2
|align = "center"|Aug-05
|-
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00333554?order=1 Docosahexaenoic acid (DHA)]
|align = "justify"|NIDDK
|align = "justify"|N/A
|align = "center"|2
|align = "center"| June 2006
|-
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00400491?order=1 Vitamin D]
|align = "justify"|University of Tromso
|align = "justify"|The purpose of the study is to evaluate if supplementation with vitamin D in a dose of 40.000 IU per week will result in improved metablic control in patients with type 2 diabetes.
|align = "center"|2
|align = "center"|Jun-06
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00351234?order=25 Carnitine Supplementation]
|align = "justify"|Children<nowiki>’</nowiki>s Mercy Hospital Kansas City,Sigma Tau Pharmaceuticals, Inc, Minimed Pharmaceuticals, Pharmacia/Upjohn Career Development Award
|align = "justify"|The purpose of this study is to determine whether type I diabetics with carnitine deficiency exhibit increased numbers of hypoglycemic (low blood sugars) events and if unrecognized hypoglycemia occurs during continuous 72-hour glucose monitoring. If they are determined to have unrecognized hypoglycemia, then oral carnitine supplementation will be given to those subjects and they will be reassessed for the number of hypoglycemic events in a 72-hour glucose monitoring.
|align = "center"|
|align = "center"|Oct-04
|-
|align = "center" colspan = "5"|'''Antiinflammatory'''
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00339833?order=63 Salsalate]
|align = "justify"|NIDDK,National Institutes of Health Clinical Center
|align = "justify"|This study, conducted at the Phoenix Indian Medical Center, Phoenix, Arizona, will determine whether reducing subclinical inflammation lessens insulin resistance in healthy, obese volunteers.
|align = "center"|4
|align = "center"|Mar-03
|-
|align = "center" colspan = "5"|'''Angiotensin (AT 2) Antagonist/blocker'''
|-
|align = "justify"| Olmesartan
|align = "justify"|Daiichi Sankyo Inc
|align = "justify"|N/A
|align = "center"|3
|align = "center"|Oct-04
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00422487?order=35 MBX-2044]
|align = "justify"|Metabolex
|align = "justify"|The purpose of this study is to collect important information regarding the glucose-lowering efficacy of MBX-2044 and the safety of MBX-2044 (especially weight gain and edema) in diabetics. It will also provide important information about the appropriate doses to be used in subsequent longer-term studies to evaluate the safety and efficacy of MBX-2044 alone and in combination with other anti-diabetic agents.
|align = "center"|2
|align = "center"|Oct-06
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00473525?order=39 PF-00734200]
|align = "justify"|Pfizer
|align = "justify"|The purpose of this Phase 2a study is to evaluate the efficacy, safety and tolerability, of multiple parallel doses of PF-00734200 following oral administration to adult human subjects with T2DM who currently are on a stable dose of metformin.
|align = "center"|2
|align = "center"|Jun-07
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00391196?order=41 CP-945,598]
|align = "justify"|Pfizer
|align = "justify"|The purpose of this study is to determine if CP-945,598 is effective in the treatment of obesity in type 2 diabetic patients
|align = "center"|3
|align = "center"|Nov-06
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00147745?order=46 WelChol® (colesevelam)]
|align = "justify"|Daiichi Sankyo Inc
|align = "justify"|This study is designed to assess the potential mechanism of action by which WelChol® (colesevelam) may improve blood glucose control in patients with type 2 diabetes
|align = "center"|2
|align = "center"|May-05
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00461006?order=61 Aleglitazar and Actos®]
|align = "justify"|Hoffmann-La Roche
|align = "justify"|This study will compare the effects of aleglitazar and Actos®, added to preexisting oral antihyperglycemic therapy and/or diet and exercise, on renal function in patients with type 2 diabetes, and normal or mildly impaired renal function.
|align = "center"|2
|align = "center"| June 2007
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00328172?order=67 BI 1356 BS]
|align = "justify"|Boehringer Ingelheim Pharmaceuticals
|align = "justify"|The objective of this monotherapy study is to investigate the efficacy, safety, and tolerability of 3 doses of BI 1356 BS compared to placebo over 12 weeks of treatment in patients with type 2 diabetes and insufficient control of thier blood glucose. In addition, there will be an open-label treatment arm with metformin. The hypothesis of the trial is that the test drug, BI 1356 BS will lead to better control of blood glucose compared to placebo after 12 weeks of treatment.
|align = "center"|2
|align = "center"|May-06
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00357370?order=84 BMS-512148]
|align = "justify"|Bristol-Myers Squibb
|align = "justify"|The purpose of this clinical research study is to learn if BMS-512148, added to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone), can help reduce the blood sugar levels compared to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone) alone, in subjects with type 2 diabetes.
|align = "center"|2, 3
|align = "center"| October 2006
|-
|align = "center" colspan = "5"|'''Parenteral routes'''
|-
|align = "center" colspan = "5"|'''Insulins'''
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00349986?order=3 Insuline glargine]
|align = "justify"|Sanofi-Aventis
|align = "justify"|Purpose ogf this study is to determine rhe first dose and titration of basal insulin
|align = "center"|4
|align = "center"|May-06
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00360698?order=2 Basal Insulin Plus Insulin Glulisine]
|align = "justify"|Sanofi-Aventis
|align = "justify"|To evaluate the efficacy of a single injection of glulisine before the main meal added to insulin glargine plus oral antidiabetic drugs (OADs) compared to insulin glargine plus OADs in Type 2 diabetic patients poorly controlled with basal insulin plus OADs.
|align = "center"|4
|align = "center"|Jul-06
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00282971?order=10 Inhaled Insulin (Exubera)]
|align = "justify"|Pfizer
|align = "justify"|To assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes who are not well controlled on 2 or more oral anti-diabetic agents
|align = "center"|3
|align = "center"|Mar-06
|-
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00325364?order=1 Insulin Inhalation Powder]
|align = "justify"|Eli Lilly and Company
|align = "justify"|This is a phase 3, open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected pre-meal insulin in non-smoking patients with type 2 diabetes. Patients will be treated for 24 months with a 2-month follow-up period.
|align = "center"|3
|align = "center"|Apr-06
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00455858?order=51 Levemir]
|align = "justify"|Novo Nordisk
|align = "justify"|This trial aims for a comparison of the effect on glycaemic control in subjects with type 2 diabetes under both established Western algorithm and Korean practical algorithm, given in combination with oral diabetic drug(s)
|align = "center"|4
|align = "center"|Aug-07
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00228878?order=69 Pulsatile IV Insulin]
|align = "justify"|Florida Atlantic University
|align = "justify"|The purpose of this study is to determine if restoring normal metabolic function in patients with either type I or type II diabetes can improve the impact of the consequences of diabetic complications on the overall quality of life of diabetic patients. Patients are treated once a week with pulsatile intravenous insulin therapy mimicking normal insulin secretion.
|align = "center"|2, 3
|align = "center"|Mar-03
|-
|align = "center" colspan = "5"|'''Incretin Minetic'''
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00360334?order=9 Exenatide With Basal Insulin]
|align = "justify"|Amylin Pharmaceuticals, Eli Lilly
|align = "justify"|This is a phase 3 trial designed to compare the effects of twice daily exenatide plus oral antidiabetic agents (OADs) and once-daily insulin glargine plus OADs with respect to glycemic control, as measured by hemoglobin A1c, with minimum weight gain, in patients with uncontrolled type 2 diabetes on OADs.
|align = "center"|3
|align = "center"|Jun-06
|-
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00456300?order=1 Exenatide]
|align = "justify"|Baylor College of Medicine, NIH
|align = "justify"|The purpose of this study is to see if giving exenatide and insulin before a meal would lower blood sugars after the meal.
|align = "center"|4
|align = "center"|Mar-07
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00434954?order=11 Exenatide Plus Metformin vs. Insulin Aspart Plus Metformin]
|align = "justify"|Amylin Pharmaceuticals, Eli Lilly
|align = "justify"|This study in Germany is designed to compare the effects of twice-daily exenatide plus metformin and twice-daily premixed human insulin aspart plus metformin with respect to glycemic control, as measured by HbA1c, combined with the percentage of patients with at least one treatment-emergent hypoglycemic episode. Patients will be treated with study therapy for approximately 26 weeks.
|align = "center"|3
|align = "center"|Feb-07
|-
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00451113?order=1 Sitigliptin]
|align = "justify"|Merck Frosst Canada Ltd, University of British Columbia
|align = "justify"|
|align = "center"|2
|align = "center"|Nov-06
|-
|align = "center" colspan = "5"|'''Antibodies'''
|-
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00129259?order=1 hOKT3gamma1 (Ala-Ala)]
|align = "justify"|NIAID
|align = "justify"|hOKT3gamma1 (Ala-Ala) is a man-made antibody that is commonly used to prevent organ rejection. The purpose of this study is determine whether hOKT3gamma1 (Ala-Ala) can halt the progression of newly diagnosed type 1 diabetes.
|align = "center"|2
|align = "center"|Sep-05
|-
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00279305?order=1 Anti-CD20 (rituximab)]
|align = "justify"|NIDDK, NICHD, NIAID, NICR, ADA, JDRF
|align = "justify"|This study will investigate the use of rituximab to see if it can help lower the number of immune B cells thereby preventing the destruction of any remaining insulin producing beta cells that remain at diagnosis.
|align = "center"|2, 3
|align = "center"|Dec-06
|-
|align = "center" colspan = "5"|'''Surgical'''
|-
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00303134?order=1 Islet Cell Transplants]
|align = "justify"|Weill Medical College of Cornell University
|align = "justify"|
|align = "center"|1
|align = "center"|Aug-03
|-
|}

==Conferences==
* [http://www.keystonesymposia.org/Meetings/ViewMeetings.cfm?MeetingID=922 Diabetes Mellitus, Insulin Action and Resistance] at Breckenridge, Colorado from January 22 - 27, 2008
* [http://www.diabetes.org.uk/Professionals/Conferences_and_events/Annual-Professional-Conference-2008/ Diabetes UK Annual Professional Conference 2008] at Glasgow from 05 Mar 2008 09:00 to 07 Mar 2008 17:00
* [http://www.conferencealerts.com/seeconf.mv?q=ca13a3h0 7th International Diabetes Federation Western Pacific Region Congress] at Wellington, New Zealand on 30 Mar 2008.
* [http://debussy.hon.ch/cgi-bin/confevent?aff2+CONF07692+Diabetes_Mellitus 1st International Conference on Advanced Technologies & Treatments for Diabetes] at Czech Republic during 27 Feb to 01 Mar 2008.
* [http://www.goingtomeet.com/conventions/details/5301 Discovery Strategies Conference: Modeling Human Metabolic Syndrome and Type 2 Diabetes in Rodents] at Us during Aug-05-2007.
* [http://www.goingtomeet.com/conventions/details/15113 7th International Conference for Clinical Endocrinology,Diabetes and Infertility] at Egypt during Sep-06-2007.
* [http://www.diabetes.ca/section_professionals/confindex.asp CDA/CSEM Professional Conference and Annual Meetings] at British Columbia during October 24-27, 2007.

===Conference Update: [http://www.diabetes.org/home.jsp American Diabetic Association 2007] ===
==== Conference highlights for Oral Hypoglycemic Agents ====

# [[Oral_Diabetes_Drugs#Products:_Oral_Hypoglycemic_Agents|Oral hypoglecemic agents]] and their role in diabetes treatment. The focus was the recent meta analysis published in [http://content.nejm.org/cgi/content/full/356/24/2457?ijkey=9288cc5edfcb35c1e7f1bd5d974d1169d64cea0b NEJM], showing increase CV mortality with Rosiglitazone. The panel consensus was that while awaiting more safety data, for now those patients who are tolerating Rosiglitazone should continue taking them, whereas newly diagnosed patients should try alternative treatment. Also all PPAR agonists should be treated as distinct entities rather than having class effect.
# 12 different [[Oral_Diabetes_Drugs#Products:_Oral_Hypoglycemic_Agents| diabetes products]] are in various stages of development, and there were about 55 abstracts talking about DPP–IV inhibitors. They are especially useful for:
#* The elderly
#* Those with renal insufficiency
#* Heart failure patients
#[http://www.amylin.com/pipeline/symlin.cfm Amyline] analogue (Pramlinitide) was combined with Insulin for treatment of Type 2 DM and results were favorable.
# Continuous glucose monitoring using implanted glucose sensors is a step forward in evolving technology. Yet it is still very expensive and best for highly trained patients on intensive insulin therapy.

Oral Diabetes Drugs

2007-10-16T10:33:50Z

Rajiv: /* Product pipeline */

Diabetes is a disease caused by high levels of blood glucose resulting from improper production of insulin or action of insulin.

* '''Type 1''': In this Diabetes, the cells that make the hormone insulin regulate the blood glucose are destroyed by the body immune system. This is also called as juvenile onset diabetes as it occurs mainly in children and young adults. 5%-10% of all the cases of diabetes have Type I diabetes. Clinical trials are being pursued and planned to prevent type I diabetes. This is also called as Insulin Dependent Diabetes Mellitus (IDDM).
* '''Type 2''': In this case, either the cells do not use insulin properly or the body does not produce enough insulin. 90% - 95% of the diabetics have Type 2 diabetes. This type of disease is also called as non-insulin dependent diabetes mellitus (NIDDM) and is mainly observed in people with old age, obese, family history of diabetes, history of gestational diabetes, impaired glucose metabolism, physical inactivity and race/ethnicity.
* '''Gestational Diabetes''': Increase in the levels of blood sugar during pregnancy is called gestational diabetes.

==Incidence and prevalence==
===Incidence===
In year 2004, diabetes ( Both type I and type II ) was diagnosed in 1.4 million adults between the age of 18-79 years (Figure 1). The incidence of diabetes was lower in adults having an age between 18-44 years compared to other groups (Figure 2). From 1997 through 2004, the age adjusted incidence of diagnosed diabetes ( Both type I and type II )increased by 35% among men and 46% among women (Figure 3).

[[Image:Number in thousands vs Year.jpg|left|250 px|thumb|Figure 1. Annual number (in thousands) of new cases of diagnosed diabetes among adults aged 18-79 years, in United States from 1997-2004. [http://www.cdc.gov/diabetes/statistics/incidence/fig1.htm Source]]]

[[Image: Rate per 1000 vs gender.gif|right|250 px|thumb|
Figure 3. Gender based incidence of diagnosed diabetes per 1000 population aged from 18-79 years in U.S. [http://www.cdc.gov/diabetes/statistics/incidence/fig4.htm Source]]]

[[Image: Rate per 1000 vs Year.jpg|center|250 px|thumb|Figure 2. Incidence of diagnosed diabetes per 1000 population aged 18-79 years, by age in U.S from 1997 to 2004. [http://www.cdc.gov/diabetes/statistics/incidence/fig3.htm Source]]].

*The following table attempts to extrapolate the incidence rate for Diabetes( both type I and type II ) to the populations of various countries and regions.[http://cureresearch.com/d/diabetes/stats-country.htm Cure reasearch, Statistics by Country for Diabetes]
{|border="2" cellspacing="0" cellpadding="4" width="86%"
|align = "center" bgcolor = "#FFFF00"|''' S.NO'''
|bgcolor = "#FFFF00"|'''Country/Region'''
|bgcolor = "#FFFF00"|'''Extrapolated incidence'''
|-
|align = "center"|1
| USA
|861,533
|-
|align = "center"|2
|Canada
|95,372
|-
|align = "center"|3
|Europe
|1,474,002
|-
|align = "center"|4
|Asia
|10,063,645
|-
|align = "center"|5
|Africa
|1,290,255
|-
|align = "center"|6
|Middle east
|1,055,809
|-
|align = "center"|7
|Australia and Southern Pacific
|70,138
|-
|}

===Prevalence===
The prevalence of diabetes( Both type I and type II ) in U.S. during the years 1980 to 2005, increased from 5.6 million to 15.8 million (Figure 4). Especially people aged from 65 to 74 had the highest prevalence compared to other age groups (Figure 5). The prevalence of the disease was similar in both men and women till the year 1998 but from 1999, the prevalence of the disease increased highly in men compared to females (Figure 6).

[[Image:Number vs Year.jpg|left|250 px|thumb|Figure 4. Number (millions) of persons with diagnosed diabetes from year 1980 to 2005 in United States. [http://www.cdc.gov/diabetes/statistics/prev/national/figpersons.htm Source]]]

[[Image:Rate_per_100_vs_Age.jpg|right|250 px|thumb|Figure 5. Age dependent Prevalence of diagnosed diabetes in United States from year 1980 to 2005. [http://www.cdc.gov/diabetes/statistics/prev/national/figbyage.htm Source]]]

[[Image:Rate per 100 vs Year.jpg|center|250 px|thumb|Figure 6. Gender dependent Prevalence of diagnosed diabetes in United States from year 1980 to 2005. [http://www.cdc.gov/diabetes/statistics/prev/national/figbysex.htm Source]]].
*The following table attempts to extrapolate the prevalence rate for Diabetes( both type I and type II ) to the populations of various countries and regions.[http://cureresearch.com/d/diabetes/stats-country.htm Cure reasearch, Statistics by Country for Diabetes].
{|border="2" cellspacing="0" cellpadding="4" width="86%"
|align = "center" bgcolor = "#FFFF00"|''' S.NO'''
|bgcolor = "#FFFF00"|'''Country/Region'''
|bgcolor = "#FFFF00"|'''Extrapolated Prevalence'''
|-
|align = "center"|1
| USA
|17,273,847
|-
|align = "center"|2
|Canada
|1,912,227
|-
|align = "center"|3
|Europe
|33,882,009
|-
|align = "center"|4
|Asia
|201,777,550
|-
|align = "center"|5
|Africa
|25,393,535
|-
|align = "center"|6
|Middle east
|21,169,243
|-
|align = "center"|7
|Australia and Southern Pacific
|1,406,291
|-
|}

==Market Overview==
* The Insulin market in 2006 was largely dominated by two players, Novo Nordisk of Denmark and Eli Lilly of USA.
* India and China are emerging as the most potential future markets for insulin delivery devices.
* Growing at a CAGR of 14.09%, global insulin market will reach US$ 14.5 Billion by 2010 from US$ 7.5 Billion in 2005.
* Over 60% of the insulin sold in 2006 was sold in pen devices.
* Insulin pen devices dominate the market in Europe and Japan whereas syringes and pumps dominate the US market.
* There was a big improvement in the global diabetes market for innovation particularly in the field of non-invasive methods of insulin delivery, including inhalable, oral and patch technology. [http://www.marketresearch.com/product/display.asp?productid=1491639&g=1 Source]
* There are 3 key new OAD classes; PPAR agonists, GLP-1 agonists/DPP IV inhibitors, and amlinomimetic agents. High forecasted sales are anticipated in 2011 for the GLP-1 agonist Exenatide LAR and the DPP-IV inhibitor Galvus at $2,902.9m and $1,228.7m, respectively. [http://www.marketresearch.com/product/display.asp?productid=1286835&g=1 Source]

[[Image:Diabetic market data.jpeg|thumb|center|800 px|]]

A. [http://www.globalbusinessinsights.com/content/rbhc0159m.pdf Competitive dynamics of the leading players in the global diabetes market, 2005]
B. [http://www.globalbusinessinsights.com/content/rbhc0159m.pdf Global diabetes market share by geography, 2005]]
C. [http://www.bccresearch.com/editors/RB-158.html Worldwide Diabetes Market, 2000, 2001, 2002 and 2007]
D. [http://www.globalbusinessinsights.com/content/rbhc0126m.PDF Global* market share of leading insulins (%), 1999-2003]

==Product Information==

[[Image:diabetes4.jpg|800 px|center|thumb| Overall categorization of diabetes treatments]]

===Products: Oral Hypoglycemic Agents===
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|bgcolor = "#FFFF00" colspan = "4"|Oral Hypoglycemic Agents
|-
|bgcolor = "#CCFFFF"|'''Drug'''
|bgcolor = "#CCFFFF"|'''Brand'''
|bgcolor = "#CCFFFF"|'''Company'''
|bgcolor = "#CCFFFF"|'''Availability'''
|-
|colspan = "4" | '''Sulfonylureas'''
|-
|'''First Generation'''
| 
| 
| 
|-
|Acetohexomide
|Dymelor
|Eli Lilly
|US, F, G, I, S,UK, J
|-
|Chlorpropamide, Tolazamide
|Diabenase
|Pfizer
|US, F, G, I, S,UK, J
|-
|'''Second Generation'''
| 
| 
| 
|-
|Glyburide (Glibenclamide)
|Diabeta
|Aventis
|US, F, G, I, S,UK, J
|-
|Glyburide (Glibenclamide)
|Micronase
|Pharmacia
|US, F, G, I, S,UK, J
|-
|Glyburide (Glibenclamide)
|Glynase
|Pharmacia
|US, F, G, I, S,UK, J
|-
|Glypizide
|Glucotrol, Glucotrol XL
|Pfizer
|US, F, G, I, S,UK, J
|-
|'''Third Generation'''
| 
| 
| 
|-
|Glimepride
|Amaryl
|Aventis
|US, F, G, I, S,UK, J
|-
|colspan = "4" |'''Meglitnides'''
|-
|Repaglinide
|Prandin
|Novo Nordisk
|US, F, G, I, S,UK, J
|-
|Nateglinide
|Sralix
|Novartis
|US,UK, J
|-
|colspan = "4" |'''Biguanides'''
|-
|Metfromin
|Glucophage, Glucophage XR
|Bristol-Myers Squibb
|US
|-
|Metfromin
| 
| 
| 
|-
|colspan = "4" |'''Thiazolidinediones'''
|-
|Rosiglitazone
|Avandia
|Glaxosmithkline
|US, G, UK
|-
|Pioglitazone
|Actos
|Takeda/ Eli Lilly
|US, UK, G, S, J
|-
|colspan = "4" |'''Alfa-Glucosidase Inhibitors'''
|-
|Acarbose
|Precose
|Bayer
|US, F, G, I, S,UK, J
|-
|Miglitol
|Glyset
|Pharmacia
|US, F, G, S
|-
|Voglibose
|Basen, Volix, Vogseal
|Ranbaxy, Nihon Pharmaceutical Industry Ltd
|I, J
|-
|colspan = "4"|'''Dipeptidyl peptidase-4 (DPP-4) inhibitor'''
|-
|Sitgliptin
|Januvia
|Merck
|US
|-
|}

===Products: Fixed Drug Combinations===
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|align = "center" colspan = "4"|'''Fixed Drug Combinations'''
|-
|bgcolor = "#CCFFFF"|'''Brand Name'''
|bgcolor = "#CCFFFF"|'''Drug 1'''
|bgcolor = "#CCFFFF"|'''Drug 2'''
|bgcolor = "#CCFFFF"|'''Company'''
|-
|Metaglip
|Glipizide
|Metformin
|Bristol-Myers Squibb
|-
|Duetact
|Glimepiride
|Pioglitazone
|Takeda
|-
|Avandaryl
|Glimepiride
|Rosiglitazone
|GlaxoSmithKline
|-
|ACTOSPlusMet
|Pioglitazone
|Metformin
|Takeda
|-
|Avandamet
|Rosiglitazone
|Metformin
|GlaxoSmithKline
|-
|Janumet
|Sitgliptin
|Metformin
|Merck
|-
|}

===Product pipeline===

[[Image:Roche.jpg|thumb|center|600px|]]
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|align = "center" bgcolor = "#FFFF99" colspan = "3" |'''Product Pipeline'''
|-
|align = "center" bgcolor = "#FFCC99"|'''Drug'''
|align = "center" bgcolor = "#FFCC99"|'''Company'''
|align = "center" bgcolor = "#FFCC99"|'''Stage'''

|-
|align = "center" colspan = "3"|'''Dipeptidyl Peptidase IV (DPP-IV) Inhibitor ''':DPP-IV inactivates glucagon-like peptide-1 (GLP-1), an important mediator of blood glucose levels following meals. DPP-IV inhibitors have been clinically shown to provide long term improvement of glucose control without the risk of hypoglycemia, and to improve the function of pancreatic beta cells, the cells responsible for the production of insulin.

|-
|align = "center"|ALS 2-0426
|align = "center"|[http://www.amgen.com/investors/pipe.jsp Alantos Pharmaceuticals, Amgen, Servier]
|align = "center"|1

|-
|align = "center"|PSN9301
|align = "center"|[http://www.osip.com/PSN9301 OSI]
|align = "center"|2

|-
|align = "center"|SYR-322
|align = "center"|[http://findarticles.com/p/articles/mi_m0RSB/is_2006_Jan_21/ai_n16017480 Takeda]
|align = "center"|3

|-
|align = "center"|R1579
|align = "center"|[http://www.roche.com/home/investors/inv_pipeline/inv_pipeline_det.htm?ta=Metabolism&Phase=%25&submit=Show+pipeline Roche]
|align = "center"|1

|-
|align = "center"|vildagliptin (Galvus)
|align = "center"|[http://www.pharma.us.novartis.com/newsroom/pressReleases/releaseDetail.jsp?PRID=1984 novartis]
|align = "center"|NDA submitted in March 2006

|-
|align = "center"|MP-513
|align = "center"|[http://www.m-pharma.co.jp/cgi-bin/pageview.cgi?pass=/e/develop/situation.html Mitsubishi Pharma]
|align = "center"|2

|-
|align = "center"|Gastrin <nowiki>+</nowiki> DPP IV Inhibitor
|align = "center"|[http://www.transitiontherapeutics.com/technology/index.php Transition Therapeutics]
|align = "center"|Preclinical

|-
|align = "center"|Saxagliptin
|align = "center"|[http://www.bms.com/research/content/data/pipeline.html Otsuka Pharmaceutical Co, Bristol-Myers Squibb]
|align = "center"|3

|-
|colspan = "3"|'''Insulin sensitizer'''

|-
|align = "center"|ISIS 113715
|align = "center"|[http://www.isispharm.com/product_pipeline.html Isis]
|align = "center"|3

|-
|align = "center"|NCX 4016 (Nitric Oxide donating derivative of Acetyl Salicylic acid)
|align = "center"|[http://www.nicox.com/update/NCX_4016.html NicOx]
|align = "center"|2

|-
|align = "center"|DG070 inhibitors
|align = "center"|[http://www.develogen.com/en/prod_pipeline.php?hnav=2&tnav=0 Develogen AG]
|align = "center"|Preclinical

|-
|align = "center"|NovoNorm® (repaglinide)/Metformin
|align = "center"|[http://www.novonordisk.com/science/pipeline/rd_pipeline.asp?showid=6 Novo Nordisk]
|align = "center"|3

|-
|colspan = "3"|'''Biguanides'''
|-
|-

|-
|align = "center"|Gastrin <nowiki>+</nowiki> Metformin
|align = "center"|[http://www.transitiontherapeutics.com/technology/index.php Transition Therapeutics]
|align = "center"|1

|-
|colspan = "3"|'''GLP 1 Analogue / Agonists''' GLP 1 Analogues have to be injected subcutaneously, Emisphere is working on an oral analogue

|-
|align = "center"|Abiglutide (716155)
|align = "center"|[http://www.gsk.com/investors/product_pipeline/docs/pipeline.pdf glaxosmithkline]
|align = "center"|2
|-
|align = "center"|TH0318
|align = "center"|[http://www.drugresearcher.com/news/ng.asp?id=58974-new-diabetic-drug Theratechnolgies]
|align = "center"|1

|-
|align = "center"|Liraglutide (NN2211)
|align = "center"|[http://www.novonordisk.com/science/pipeline/rd_pipeline.asp?showid=4 Novo Nordisk]
|align = "center"|3

|-
|align = "center"|R1583
|align = "center"|[http://www.roche.com/home/investors/inv_pipeline/inv_pipeline_det.htm?ta=Metabolism&Phase=%25&submit=Show+pipeline Roche]
|align = "center"|2

|-
|align = "center"|Oral GLP
|align = "center"|[http://www.emisphere.com/product_pipeline.asp Emisphere Technologies]
|align = "center"|1

|-
|align = "center"|PC-DAC™:Exendin-4
|align = "center"|[http://conjuchem.hyphenhealth.com/ ConjuChem]
|align = "center"|2

|-
| 
|align = "center"|[http://www.bms.com/research/content/data/pipeline.html Bristol-Myers Squibb ]
|align = "center"|Exploratory development

|-
|align = "center"|AVE0001A
|align = "center"|[http://en.sanofi-aventis.com/rd/portfolio/p_rd_portfolio_metabo.asp Sanofi Aventis]
|align = "center"|2

|-
|align = "center"|Gastrin <nowiki>+</nowiki>GLP 1 Agonist
|align = "center"|[http://www.transitiontherapeutics.com/technology/index.php Transition Therapeutics]
|align = "center"|2

|-
|colspan = "3"|'''Peroxisome Proliferator-Activated Receptor (PPAR) agonist/analogue'''

|-
|align = "center"|CS-011 (Rivoglitazone)
|align = "center"|Sankyo
|align = "center"|2

|-
|align = "center"|Metaglidasen(MBX 102)
|align = "center"|[http://www.medicalnewstoday.com/articles/26017.php Metabolex]
|align = "center"|2

|-
|align = "center"|MBX-2044
|align = "center"|[http://www.metabolex.com/pipeline.html Metabolex]
|align = "center"|1

|-
|align = "center"|AVE8134
|align = "center"|[http://en.sanofi-aventis.com/rd/portfolio/p_rd_portfolio_metabo.asp Sanofi Aventis]
|align = "center"|2

|-
|align = "center"|AVE0897
|align = "center"|[http://en.sanofi-aventis.com/rd/portfolio/p_rd_portfolio_metabo.asp Sanofi Aventis]
|align = "center"|1

|-
|align = "center"|R1439, aleglitazar
|align = "center"|[http://www.roche.com/home/investors/inv_pipeline/inv_pipeline_det.htm?ta=Metabolism&Phase=%25&submit=Show+pipeline Roche]
|align = "center"|2

|-
|align = "center"|AVE0847
|align = "center"|[http://en.sanofi-aventis.com/rd/portfolio/p_rd_portfolio_metabo.asp Sanofi Aventis]
|align = "center"|2

|-
|align = "center"|SAR351034
|align = "center"|[http://en.sanofi-aventis.com/rd/portfolio/p_rd_portfolio_metabo.asp Sanofi Aventis]
|align = "center"|Preclinical

|-
|align = "center"|376501
|align = "center"|[http://www.gsk.com/investors/pp_pipeline_standard.htm Glaxosmithkline]
|align = "center"|1

|-
|align = "center"|625019
|align = "center"|[http://www.gsk.com/investors/pp_pipeline_standard.htm Glaxosmithkline]
|align = "center"|1

|-
|align = "center"|677954
|align = "center"|[http://www.gsk.com/investors/pp_pipeline_standard.htm Glaxosmithkline]
|align = "center"|2

|-
|align = "center"|Avandia
|align = "center"|[http://www.gsk.com/investors/pp_pipeline_standard.htm Glaxosmithkline]
|align = "center"|2

|-
|align = "center"|Avandia XR
|align = "center"|[http://www.gsk.com/investors/pp_pipeline_standard.htm Glaxosmithkline]
|align = "center"|2

|-
|align = "center"|PPAR Gamma Agonist <nowiki>+</nowiki> simvaststin
|align = "center"|[http://www.gsk.com/investors/pp_pipeline_standard.htm Glaxosmithkline]
|align = "center"|3

|-
|align = "center"|MCC-555, Netoglitazone
|align = "center"|[http://www.m-pharma.co.jp/cgi-bin/pageview.cgi?pass=/e/develop/situation.html Mitsubishi Pharma, Novartis]
|align = "center"| 

|-
|align = "center"|Muraglitzar
|align = "center"|[http://www.drugs.com/nda/muraglitazar_041223.html Bristol-Myers Squibb ]
|align = "center"|3

|-
|align = "center"|R483
|align = "center"|[http://www.roche.com/pages/downloads/investor/pdf/praesentations/irp050504rdd14.pdf Roche]
|align = "center"|2

|-
|align = "center"|PPM-204
|align = "center"|[http://www.wyeth.com/research/pipeline Wyeth], [http://www.invitrogen.com/downloads/Discovery_Inhibitor_Oncogenic_B-RAF.pdf Plexxikon]
|align = "center"|2

|-
|colspan = "3"|'''Oral glucokinase activator (GKA)'''

|-
|align = "center"|PSN010
|align = "center"|[http://www.osip.com/PSN010 OSI]
|align = "center"|1

|-
|align = "center"|R1511
|align = "center"|[http://www.roche.com/home/investors/inv_pipeline/inv_pipeline_det.htm?ta=Metabolism&Phase=%25&submit=Show+pipeline Roche]
|align = "center"|1

|-
|colspan = "3"|'''G protein-coupled Receptor(GPR) 119 Agonist'''

|-
|align = "center"|PSN821
|align = "center"|[http://www.osip.com/PSN010 OSI]
|align = "center"| 

|-
|colspan = "3"|'''Antisense drug for Glucagon Receptor (GCGR)'''

|-
|align = "center"|ISIS 325568
|align = "center"|[http://www.isispharm.com/product_pipeline.html Isis]
|align = "center"|1

|-
|colspan = "3"|'''Antisense drug for Glucocorticoid Receptor (GCCR)'''

|-
|align = "center"|ISIS 377131
|align = "center"|[http://www.isispharm.com/product_pipeline.html Isis]
|align = "center"|Preclinical

|-
|colspan = "3"|''' Sodium Glucose Transporter 2 (SGLT2) inhibitor'''

|-
|align = "center"|AVE2268
|align = "center"|[http://en.sanofi-aventis.com/rd/portfolio/p_rd_portfolio_metabo.asp Sanofi Aventis]
|align = "center"|2

|-
|align = "center"|SAR 7226
|align = "center"|[http://en.sanofi-aventis.com/rd/portfolio/p_rd_portfolio_metabo.asp Sanofi Aventis]
|align = "center"|Preclinical

|-
|align = "center"|189075
|align = "center"|[http://www.gsk.com/investors/product_pipeline/docs/pipeline.pdf Glaxosmithkline]
|align = "center"|2

|-
|align = "center"|869682
|align = "center"|[http://www.gsk.com/investors/product_pipeline/docs/pipeline.pdf Glaxosmithkline]
|align = "center"|2

|-
|colspan = "3"|'''Growth hormone releasing analogue'''

|-
|align = "center"|TH 9507
|align = "center"|[http://www.theratech.com/en/products-therapeutic-peptides/pipeline.php Theratechnolgies]
|align = "center"| 

|-
|colspan = "3"|'''Nitric oxide (NO) blocking agent'''

|-
|align = "center"|NOX-700
|align = "center"|[http://www.medinox.com/news/press.htm Medinox]
|align = "center"|1 staretd in 2002

|-
|colspan = "3"|'''Antibody'''

|-
|align = "center"|TRX4
|align = "center"|[http://www.btgplc.com/PartneredDevelopment/240/TRX4.html BTG]
|align = "center"|2

|-
|colspan = "3"|'''Selective inhibitor of fructose-1, 6-bisphosphatase (FBPase)'''
|-
|align = "center"|CS-917
|align = "center"|[http://www.mbasis.com/pipeline/metabolic_disease.html Sankyo,Metabasis]
|align = "center"|2

|-
|align = "center"|MB07803
|align = "center"|[http://www.mbasis.com/pipeline/index.html metabasis, Daiichi Sankyo]
|align = "center"|2

|-
|colspan = "3"|'''11-beta hydroxysteroid dehydrogenase type 1 (11ß-HSD1) inhibitor'''

|-
|align = "center"|AMG 221
|align = "center"|[http://wwwext.amgen.com/science/pipe_AMG221.html Amgen, Biovitrum]
|align = "center"|1

|-
|colspan = "3"|'''Polypyrimidine tract binding protein (PTB, also named hnRNP) inhibitor'''

|-
|align = "center"| 
|align = "center"|Serono
|align = "center"|1
|-
|colspan = "3"|'''Insulin Like Growth Factor 1'''
|-
|-
|align = "center"|IPLEX (Mecasermin rinfabate)
|align = "center"|Glen Allen
|align = "center"|Orphan Drug Status

|-
|colspan = "3"|'''Newer Meglitinides'''
|-
|-
|align = "center"|Nateglinide with insulin sensitizers
|align = "center"|[http://www.astellas.com/global/about/news/2006/pdf/061130_eg.pdf Astellas pharmas]
|align = "center"|SNDA Filed

|-
|align = "center"|Nateglinide with biguanides
|align = "center"|[http://www.astellas.com/global/about/news/2006/pdf/061130_eg.pdf Astellas pharmas]
|align = "center"|SNDA Filed

|-
|colspan = "3"|'''Islet Regeneration Factors'''
|-
|-
|-
|align = "center"|DG770 (beta cell regeneration factor)
|align = "center"|[http://www.develogen.com/en/prod_pipeline.php?hnav=2&tnav=0 Develogen AG]
|align = "center"|3

|-
|align = "center"|E1 INT (Islet regeneration)
|align = "center"|[http://www.transitiontherapeutics.com/technology/index.php Transition Therapeutics]
|align = "center"|2

|-
|bgcolor = "#FFFF99" colspan = "3"|'''Miscellaneous'''

|-
|align = "center"|AMG 837 (Potentiates Glucose Dependent Insulin Secretion)
|align = "center"|[http://www.amgen.com/science/pipe_amg837.html Amgen]
|align = "center"|1

|-
|align = "center"|MBX 213
|align = "center"|[http://www.metabolex.com/pipeline.html Metabolex]
|align = "center"|1

|-
|align = "center"|R 1499
|align = "center"|[http://www.roche.com/pages/downloads/investor/pdf/praesentations/irp050504rdd14.pdf Roche]
|align = "center"|1

|-
|align = "center"|R1438
|align = "center"|[http://www.roche.com/pages/downloads/investor/pdf/praesentations/irp050504rdd14.pdf Roche]
|align = "center"|2

|-
|align = "center"|R1440
|align = "center"|[http://www.roche.com/pages/downloads/investor/pdf/praesentations/irp050504rdd14.pdf Roche]
|align = "center"|2

|-
|align = "center"|PSN 357
|align = "center"|OSI
|align = "center"|1

|-
|align = "center"|NBI 6024
|align = "center"|Neurocrine Biosciences
|align = "center"|2

|-
|align = "center"|MK 0941
|align = "center"|[http://www.merck.com/finance/pipeline.swf Merck]
|align = "center"|1

|-
|align = "center"|MK 1642
|align = "center"|[http://www.merck.com/finance/pipeline.swf Merck]
|align = "center"|1

|-
|align = "center"|Mk 0533
|align = "center"|[http://www.merck.com/finance/pipeline.swf Merck]
|align = "center"|2

|-
|align = "center"|MK0893
|align = "center"|[http://www.merck.com/finance/pipeline.swf Merck]
|align = "center"|2

|-
|align = "center" bgcolor = "#FFFF99" colspan = "3"|'''Insulins'''

|-
|align = "center"|Oral Insulin
|align = "center"|[http://www.emisphere.com/pc_oi.asp Emisphere Technologies]
|align = "center"|2

|-
|align = "center"|Technosphere
|align = "center"|[http://www.mannkindcorp.com/technosphere_insulin.aspx Mannkind corporation]
|align = "center"|3

|-
|align = "center"|NN344 (Insulin analogue)
|align = "center"|[http://www.novonordisk.com/science/pipeline/rd_pipeline.asp?showid=18 Novo Nordisk]
|align = "center"|1

|-
|align = "center"|NN5401(Insulin analogue)
|align = "center"|[http://www.novonordisk.com/science/pipeline/rd_pipeline.asp?showid=19 Novo Nordisk]
|align = "center"|1

|-
|align = "center"|AERx® iDMS (Insulin Inhalation system)
|align = "center"|[http://www.novonordisk.com/science/pipeline/rd_pipeline.asp?showid=5 Novo Nordisk]
|align = "center"|3

|-
|align = "center"|Inhaled insulin
|align = "center"|Bristol Meyers Squibb
|align = "center"|1

|-
|align = "center"|Inhaled insulin
|align = "center"|[http://investor.lilly.com/pipeline.cfm Eli Lilly]
|align = "center"|2

|-
|align = "center"|Exubera (Inhaled insulin)
|align = "center"|[http://www.pfizer.com/research/cardiovascular_condition.jsp Pfizer]
|align = "center"|4

|-
|align = "center"|Oal Lyn (Inhaled insulin)
|align = "center"|[http://www.generex.com/products/oral-lyn/ http://www.generex.com/products/oral-lyn/]
|align = "center"|Approved in Ecuador

|-
|align = "center"|Nasulin
|align = "center"|[http://www.bentleypharm.com/other/pipeline Bentley]
|align = "center"|2

|}

===Product Pathways===

==Intellectual Property==
===Search strategy===
* '''Database/Vendor:''' Micropat
* '''Search scope:''' US Granted US Applications EP-A EP-B WO JP (bibliographic data only) DE-C,B DE-A DE-T DE-U GB-A FR-A; '''English Title'''
* '''Years:''' '''Issue/Publication Date:''' >20051231
* '''Search String:''' (Diabetes OR diabetic) AND (treatment OR treating)
* '''Hits:''' 618/217 patents (with/with out family members)
* '''Date of search:''' 11 July 2007

===Top players and IPC classes===

[[Image:Diabetes- top players.jpeg|center|800 px|]]

====IPC code definition====

{|border="0" cellspacing="1" width="80%"
|'''A61K'''
|Preparations for medical, dental, or toilet purposes
|-
|'''C07D'''
|Heterocyclic compounds
|-
|'''C07K'''
|Peptides
|-
|'''C12N'''
|Micro-organisms or enzymes; compositions thereof
|-
|'''C12Q'''
|Measuring or testing processes involving enzymes or micro-organisms (immunoassay); compositions or test papers therefor; processes of preparing such compositions; condition-responsive control in microbiological or enzymological processes
|-
|}

===Geographical Distribution and Treatment Approaches===

[[Image:Diabetes -geographical.jpeg|center|800 px|]]

===IP activity and Treatment Approaches===
* Decline in the IP activity during 2005 and 2006 is due 18 months publication delay of patent document.
[[Image:Diabetes -year approach.jpeg|center|800 px|]]

==Clinical Trials==
===Approved/On-going===
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|align = "center" bgcolor = "#FFFF99" colspan = "5"|'''Clinical trials'''
|-
|align = "center"|'''Drug'''
|align = "center"|'''Sponsors'''
|align = "center"|'''Description'''
|align = "center"|'''Phase'''
|align = "center"|'''Date of Start'''
|-
|align = "center" colspan = "5"|'''Oral Drugs'''
|-
|align = "center" colspan = "5"|'''Cannabinoid receptor antagonist'''
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00478595?order=1 Rimonabant]
|align = "justify"|Sanofi-Aventis
|align = "justify"|The primary objective of this study is to assess the efficacy of SR141716 (rimonabant) compared to placebo on change in HbA1c and on relative change in body weight over 52 weeks in obese type 2 diabetic patients on monotherapy inadequately controlled with oral anti-diabetic drug (sulfonylurea or ?-glucosidase inhibitor).
|align = "center"|3
|align = "center"|May-07
|-
|align = "center" colspan = "5"|'''Insulin Sensitisers'''
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00353587?order=24 Metaglidasen]
|align = "justify"|Metabolex
|align = "justify"|
|align = "center"|2, 3
|align = "center"|May-06
|-
|align = "center" colspan = "5"|'''Thioglitazone'''
|-
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00386100?order=1 Rosiglitazone maleate/metformin hydrochloride (AVANDAMET)]
|align = "justify"|GlaxoSmithKline
|align = "justify"|This study will evaluate the longer-term glycemic effect of two medicines approved for initial treatment of type 2 diabetes.
|align = "center"|4
|align = "center"|Oct-06
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00515632?order=8 Balaglitazone]
|align = "justify"|Rheoscience A/S
|align = "justify"|Balaglitazone is a thiazolidinedione derivative that is being developed as an oral anti-diabetic drug to improve blood glucose control in patients with type 2 diabetes. The purpose of this study is to assess if additional treatment with balaglitazone in patients with type 2 diabetes on stable insulin treatment will improve blood glucose control and decrease the daily insulin dose, but with less impact on weight gain and oedema.
|align = "center"|3
|align = "center"|Jul-07
|-
|align = "center" colspan = "5"|'''(DPP-4) inhibitor'''
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00351884?order=18 Vildagliptin]
|align = "justify"|Novartis
|align = "justify"|This is a 24-week study to assess the efficacy on HbA1c of 100 mg vildagliptin once daily as compared to placebo as add-on to metformin in patients with type 2 diabetes inadequately controllled with metformin.
|align = "center"|3
|align = "center"|May-06
|-
|align = "center" colspan = "5"|'''Insulin'''
|-
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00419562?order=1 Oral Insulin]
|align = "justify"|NIDDK, NICHD, NIAID, NICR, ADA, JDRF
|align = "justify"|N/A
|align = "center"|3
|align = "center"|Feb-07
|-
|align = "center" colspan = "5"|'''Potassium Channel Blocker'''
|-
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00131755?order=1 Diazoxide]
|align = "justify"|Grill, Valdemar, M.D.
|align = "justify"|The purpose of this study is to find out if Diazoxide can partly retain insulin production in newly diagnosed type 1 diabetes patients.
|align = "center"|4
|align = "center"|Feb-05
|-
|align = "center" colspan = "5"|'''Nutritional Agents'''
|-
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00117026?order=1 Benfotiamine (Vitamin B1)]
|align = "justify"|University Hospital, Aker, The Research Council of Norway
|align = "justify"|N/A
|align = "center"|1, 2
|align = "center"|Aug-05
|-
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00333554?order=1 Docosahexaenoic acid (DHA)]
|align = "justify"|NIDDK
|align = "justify"|N/A
|align = "center"|2
|align = "center"| June 2006
|-
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00400491?order=1 Vitamin D]
|align = "justify"|University of Tromso
|align = "justify"|The purpose of the study is to evaluate if supplementation with vitamin D in a dose of 40.000 IU per week will result in improved metablic control in patients with type 2 diabetes.
|align = "center"|2
|align = "center"|Jun-06
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00351234?order=25 Carnitine Supplementation]
|align = "justify"|Children<nowiki>’</nowiki>s Mercy Hospital Kansas City,Sigma Tau Pharmaceuticals, Inc, Minimed Pharmaceuticals, Pharmacia/Upjohn Career Development Award
|align = "justify"|The purpose of this study is to determine whether type I diabetics with carnitine deficiency exhibit increased numbers of hypoglycemic (low blood sugars) events and if unrecognized hypoglycemia occurs during continuous 72-hour glucose monitoring. If they are determined to have unrecognized hypoglycemia, then oral carnitine supplementation will be given to those subjects and they will be reassessed for the number of hypoglycemic events in a 72-hour glucose monitoring.
|align = "center"|
|align = "center"|Oct-04
|-
|align = "center" colspan = "5"|'''Antiinflammatory'''
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00339833?order=63 Salsalate]
|align = "justify"|NIDDK,National Institutes of Health Clinical Center
|align = "justify"|This study, conducted at the Phoenix Indian Medical Center, Phoenix, Arizona, will determine whether reducing subclinical inflammation lessens insulin resistance in healthy, obese volunteers.
|align = "center"|4
|align = "center"|Mar-03
|-
|align = "center" colspan = "5"|'''Angiotensin (AT 2) Antagonist/blocker'''
|-
|align = "justify"| Olmesartan
|align = "justify"|Daiichi Sankyo Inc
|align = "justify"|N/A
|align = "center"|3
|align = "center"|Oct-04
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00422487?order=35 MBX-2044]
|align = "justify"|Metabolex
|align = "justify"|The purpose of this study is to collect important information regarding the glucose-lowering efficacy of MBX-2044 and the safety of MBX-2044 (especially weight gain and edema) in diabetics. It will also provide important information about the appropriate doses to be used in subsequent longer-term studies to evaluate the safety and efficacy of MBX-2044 alone and in combination with other anti-diabetic agents.
|align = "center"|2
|align = "center"|Oct-06
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00473525?order=39 PF-00734200]
|align = "justify"|Pfizer
|align = "justify"|The purpose of this Phase 2a study is to evaluate the efficacy, safety and tolerability, of multiple parallel doses of PF-00734200 following oral administration to adult human subjects with T2DM who currently are on a stable dose of metformin.
|align = "center"|2
|align = "center"|Jun-07
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00391196?order=41 CP-945,598]
|align = "justify"|Pfizer
|align = "justify"|The purpose of this study is to determine if CP-945,598 is effective in the treatment of obesity in type 2 diabetic patients
|align = "center"|3
|align = "center"|Nov-06
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00147745?order=46 WelChol® (colesevelam)]
|align = "justify"|Daiichi Sankyo Inc
|align = "justify"|This study is designed to assess the potential mechanism of action by which WelChol® (colesevelam) may improve blood glucose control in patients with type 2 diabetes
|align = "center"|2
|align = "center"|May-05
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00461006?order=61 Aleglitazar and Actos®]
|align = "justify"|Hoffmann-La Roche
|align = "justify"|This study will compare the effects of aleglitazar and Actos®, added to preexisting oral antihyperglycemic therapy and/or diet and exercise, on renal function in patients with type 2 diabetes, and normal or mildly impaired renal function.
|align = "center"|2
|align = "center"| June 2007
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00328172?order=67 BI 1356 BS]
|align = "justify"|Boehringer Ingelheim Pharmaceuticals
|align = "justify"|The objective of this monotherapy study is to investigate the efficacy, safety, and tolerability of 3 doses of BI 1356 BS compared to placebo over 12 weeks of treatment in patients with type 2 diabetes and insufficient control of thier blood glucose. In addition, there will be an open-label treatment arm with metformin. The hypothesis of the trial is that the test drug, BI 1356 BS will lead to better control of blood glucose compared to placebo after 12 weeks of treatment.
|align = "center"|2
|align = "center"|May-06
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00357370?order=84 BMS-512148]
|align = "justify"|Bristol-Myers Squibb
|align = "justify"|The purpose of this clinical research study is to learn if BMS-512148, added to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone), can help reduce the blood sugar levels compared to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone) alone, in subjects with type 2 diabetes.
|align = "center"|2, 3
|align = "center"| October 2006
|-
|align = "center" colspan = "5"|'''Parenteral routes'''
|-
|align = "center" colspan = "5"|'''Insulins'''
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00349986?order=3 Insuline glargine]
|align = "justify"|Sanofi-Aventis
|align = "justify"|Purpose ogf this study is to determine rhe first dose and titration of basal insulin
|align = "center"|4
|align = "center"|May-06
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00360698?order=2 Basal Insulin Plus Insulin Glulisine]
|align = "justify"|Sanofi-Aventis
|align = "justify"|To evaluate the efficacy of a single injection of glulisine before the main meal added to insulin glargine plus oral antidiabetic drugs (OADs) compared to insulin glargine plus OADs in Type 2 diabetic patients poorly controlled with basal insulin plus OADs.
|align = "center"|4
|align = "center"|Jul-06
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00282971?order=10 Inhaled Insulin (Exubera)]
|align = "justify"|Pfizer
|align = "justify"|To assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes who are not well controlled on 2 or more oral anti-diabetic agents
|align = "center"|3
|align = "center"|Mar-06
|-
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00325364?order=1 Insulin Inhalation Powder]
|align = "justify"|Eli Lilly and Company
|align = "justify"|This is a phase 3, open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected pre-meal insulin in non-smoking patients with type 2 diabetes. Patients will be treated for 24 months with a 2-month follow-up period.
|align = "center"|3
|align = "center"|Apr-06
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00455858?order=51 Levemir]
|align = "justify"|Novo Nordisk
|align = "justify"|This trial aims for a comparison of the effect on glycaemic control in subjects with type 2 diabetes under both established Western algorithm and Korean practical algorithm, given in combination with oral diabetic drug(s)
|align = "center"|4
|align = "center"|Aug-07
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00228878?order=69 Pulsatile IV Insulin]
|align = "justify"|Florida Atlantic University
|align = "justify"|The purpose of this study is to determine if restoring normal metabolic function in patients with either type I or type II diabetes can improve the impact of the consequences of diabetic complications on the overall quality of life of diabetic patients. Patients are treated once a week with pulsatile intravenous insulin therapy mimicking normal insulin secretion.
|align = "center"|2, 3
|align = "center"|Mar-03
|-
|align = "center" colspan = "5"|'''Incretin Minetic'''
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00360334?order=9 Exenatide With Basal Insulin]
|align = "justify"|Amylin Pharmaceuticals, Eli Lilly
|align = "justify"|This is a phase 3 trial designed to compare the effects of twice daily exenatide plus oral antidiabetic agents (OADs) and once-daily insulin glargine plus OADs with respect to glycemic control, as measured by hemoglobin A1c, with minimum weight gain, in patients with uncontrolled type 2 diabetes on OADs.
|align = "center"|3
|align = "center"|Jun-06
|-
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00456300?order=1 Exenatide]
|align = "justify"|Baylor College of Medicine, NIH
|align = "justify"|The purpose of this study is to see if giving exenatide and insulin before a meal would lower blood sugars after the meal.
|align = "center"|4
|align = "center"|Mar-07
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00434954?order=11 Exenatide Plus Metformin vs. Insulin Aspart Plus Metformin]
|align = "justify"|Amylin Pharmaceuticals, Eli Lilly
|align = "justify"|This study in Germany is designed to compare the effects of twice-daily exenatide plus metformin and twice-daily premixed human insulin aspart plus metformin with respect to glycemic control, as measured by HbA1c, combined with the percentage of patients with at least one treatment-emergent hypoglycemic episode. Patients will be treated with study therapy for approximately 26 weeks.
|align = "center"|3
|align = "center"|Feb-07
|-
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00451113?order=1 Sitigliptin]
|align = "justify"|Merck Frosst Canada Ltd, University of British Columbia
|align = "justify"|
|align = "center"|2
|align = "center"|Nov-06
|-
|align = "center" colspan = "5"|'''Antibodies'''
|-
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00129259?order=1 hOKT3gamma1 (Ala-Ala)]
|align = "justify"|NIAID
|align = "justify"|hOKT3gamma1 (Ala-Ala) is a man-made antibody that is commonly used to prevent organ rejection. The purpose of this study is determine whether hOKT3gamma1 (Ala-Ala) can halt the progression of newly diagnosed type 1 diabetes.
|align = "center"|2
|align = "center"|Sep-05
|-
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00279305?order=1 Anti-CD20 (rituximab)]
|align = "justify"|NIDDK, NICHD, NIAID, NICR, ADA, JDRF
|align = "justify"|This study will investigate the use of rituximab to see if it can help lower the number of immune B cells thereby preventing the destruction of any remaining insulin producing beta cells that remain at diagnosis.
|align = "center"|2, 3
|align = "center"|Dec-06
|-
|align = "center" colspan = "5"|'''Surgical'''
|-
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00303134?order=1 Islet Cell Transplants]
|align = "justify"|Weill Medical College of Cornell University
|align = "justify"|
|align = "center"|1
|align = "center"|Aug-03
|-
|}

==Conferences==
* [http://www.keystonesymposia.org/Meetings/ViewMeetings.cfm?MeetingID=922 Diabetes Mellitus, Insulin Action and Resistance] at Breckenridge, Colorado from January 22 - 27, 2008
* [http://www.diabetes.org.uk/Professionals/Conferences_and_events/Annual-Professional-Conference-2008/ Diabetes UK Annual Professional Conference 2008] at Glasgow from 05 Mar 2008 09:00 to 07 Mar 2008 17:00
* [http://www.conferencealerts.com/seeconf.mv?q=ca13a3h0 7th International Diabetes Federation Western Pacific Region Congress] at Wellington, New Zealand on 30 Mar 2008.
* [http://debussy.hon.ch/cgi-bin/confevent?aff2+CONF07692+Diabetes_Mellitus 1st International Conference on Advanced Technologies & Treatments for Diabetes] at Czech Republic during 27 Feb to 01 Mar 2008.
* [http://www.goingtomeet.com/conventions/details/5301 Discovery Strategies Conference: Modeling Human Metabolic Syndrome and Type 2 Diabetes in Rodents] at Us during Aug-05-2007.
* [http://www.goingtomeet.com/conventions/details/15113 7th International Conference for Clinical Endocrinology,Diabetes and Infertility] at Egypt during Sep-06-2007.
* [http://www.diabetes.ca/section_professionals/confindex.asp CDA/CSEM Professional Conference and Annual Meetings] at British Columbia during October 24-27, 2007.

===Conference Update: [http://www.diabetes.org/home.jsp American Diabetic Association 2007] ===
==== Conference highlights for Oral Hypoglycemic Agents ====

# [[Oral_Diabetes_Drugs#Products:_Oral_Hypoglycemic_Agents|Oral hypoglecemic agents]] and their role in diabetes treatment. The focus was the recent meta analysis published in [http://content.nejm.org/cgi/content/full/356/24/2457?ijkey=9288cc5edfcb35c1e7f1bd5d974d1169d64cea0b NEJM], showing increase CV mortality with Rosiglitazone. The panel consensus was that while awaiting more safety data, for now those patients who are tolerating Rosiglitazone should continue taking them, whereas newly diagnosed patients should try alternative treatment. Also all PPAR agonists should be treated as distinct entities rather than having class effect.
# 12 different [[Oral_Diabetes_Drugs#Products:_Oral_Hypoglycemic_Agents| diabetes products]] are in various stages of development, and there were about 55 abstracts talking about DPP–IV inhibitors. They are especially useful for:
#* The elderly
#* Those with renal insufficiency
#* Heart failure patients
#[http://www.amylin.com/pipeline/symlin.cfm Amyline] analogue (Pramlinitide) was combined with Insulin for treatment of Type 2 DM and results were favorable.
# Continuous glucose monitoring using implanted glucose sensors is a step forward in evolving technology. Yet it is still very expensive and best for highly trained patients on intensive insulin therapy.

File:Roche.jpg

2007-10-16T10:32:04Z

Rajiv:

Oral Diabetes Drugs

2007-10-16T10:28:29Z

Rajiv: /* Product pipeline */

Diabetes is a disease caused by high levels of blood glucose resulting from improper production of insulin or action of insulin.

* '''Type 1''': In this Diabetes, the cells that make the hormone insulin regulate the blood glucose are destroyed by the body immune system. This is also called as juvenile onset diabetes as it occurs mainly in children and young adults. 5%-10% of all the cases of diabetes have Type I diabetes. Clinical trials are being pursued and planned to prevent type I diabetes. This is also called as Insulin Dependent Diabetes Mellitus (IDDM).
* '''Type 2''': In this case, either the cells do not use insulin properly or the body does not produce enough insulin. 90% - 95% of the diabetics have Type 2 diabetes. This type of disease is also called as non-insulin dependent diabetes mellitus (NIDDM) and is mainly observed in people with old age, obese, family history of diabetes, history of gestational diabetes, impaired glucose metabolism, physical inactivity and race/ethnicity.
* '''Gestational Diabetes''': Increase in the levels of blood sugar during pregnancy is called gestational diabetes.

==Incidence and prevalence==
===Incidence===
In year 2004, diabetes ( Both type I and type II ) was diagnosed in 1.4 million adults between the age of 18-79 years (Figure 1). The incidence of diabetes was lower in adults having an age between 18-44 years compared to other groups (Figure 2). From 1997 through 2004, the age adjusted incidence of diagnosed diabetes ( Both type I and type II )increased by 35% among men and 46% among women (Figure 3).

[[Image:Number in thousands vs Year.jpg|left|250 px|thumb|Figure 1. Annual number (in thousands) of new cases of diagnosed diabetes among adults aged 18-79 years, in United States from 1997-2004. [http://www.cdc.gov/diabetes/statistics/incidence/fig1.htm Source]]]

[[Image: Rate per 1000 vs gender.gif|right|250 px|thumb|
Figure 3. Gender based incidence of diagnosed diabetes per 1000 population aged from 18-79 years in U.S. [http://www.cdc.gov/diabetes/statistics/incidence/fig4.htm Source]]]

[[Image: Rate per 1000 vs Year.jpg|center|250 px|thumb|Figure 2. Incidence of diagnosed diabetes per 1000 population aged 18-79 years, by age in U.S from 1997 to 2004. [http://www.cdc.gov/diabetes/statistics/incidence/fig3.htm Source]]].

*The following table attempts to extrapolate the incidence rate for Diabetes( both type I and type II ) to the populations of various countries and regions.[http://cureresearch.com/d/diabetes/stats-country.htm Cure reasearch, Statistics by Country for Diabetes]
{|border="2" cellspacing="0" cellpadding="4" width="86%"
|align = "center" bgcolor = "#FFFF00"|''' S.NO'''
|bgcolor = "#FFFF00"|'''Country/Region'''
|bgcolor = "#FFFF00"|'''Extrapolated incidence'''
|-
|align = "center"|1
| USA
|861,533
|-
|align = "center"|2
|Canada
|95,372
|-
|align = "center"|3
|Europe
|1,474,002
|-
|align = "center"|4
|Asia
|10,063,645
|-
|align = "center"|5
|Africa
|1,290,255
|-
|align = "center"|6
|Middle east
|1,055,809
|-
|align = "center"|7
|Australia and Southern Pacific
|70,138
|-
|}

===Prevalence===
The prevalence of diabetes( Both type I and type II ) in U.S. during the years 1980 to 2005, increased from 5.6 million to 15.8 million (Figure 4). Especially people aged from 65 to 74 had the highest prevalence compared to other age groups (Figure 5). The prevalence of the disease was similar in both men and women till the year 1998 but from 1999, the prevalence of the disease increased highly in men compared to females (Figure 6).

[[Image:Number vs Year.jpg|left|250 px|thumb|Figure 4. Number (millions) of persons with diagnosed diabetes from year 1980 to 2005 in United States. [http://www.cdc.gov/diabetes/statistics/prev/national/figpersons.htm Source]]]

[[Image:Rate_per_100_vs_Age.jpg|right|250 px|thumb|Figure 5. Age dependent Prevalence of diagnosed diabetes in United States from year 1980 to 2005. [http://www.cdc.gov/diabetes/statistics/prev/national/figbyage.htm Source]]]

[[Image:Rate per 100 vs Year.jpg|center|250 px|thumb|Figure 6. Gender dependent Prevalence of diagnosed diabetes in United States from year 1980 to 2005. [http://www.cdc.gov/diabetes/statistics/prev/national/figbysex.htm Source]]].
*The following table attempts to extrapolate the prevalence rate for Diabetes( both type I and type II ) to the populations of various countries and regions.[http://cureresearch.com/d/diabetes/stats-country.htm Cure reasearch, Statistics by Country for Diabetes].
{|border="2" cellspacing="0" cellpadding="4" width="86%"
|align = "center" bgcolor = "#FFFF00"|''' S.NO'''
|bgcolor = "#FFFF00"|'''Country/Region'''
|bgcolor = "#FFFF00"|'''Extrapolated Prevalence'''
|-
|align = "center"|1
| USA
|17,273,847
|-
|align = "center"|2
|Canada
|1,912,227
|-
|align = "center"|3
|Europe
|33,882,009
|-
|align = "center"|4
|Asia
|201,777,550
|-
|align = "center"|5
|Africa
|25,393,535
|-
|align = "center"|6
|Middle east
|21,169,243
|-
|align = "center"|7
|Australia and Southern Pacific
|1,406,291
|-
|}

==Market Overview==
* The Insulin market in 2006 was largely dominated by two players, Novo Nordisk of Denmark and Eli Lilly of USA.
* India and China are emerging as the most potential future markets for insulin delivery devices.
* Growing at a CAGR of 14.09%, global insulin market will reach US$ 14.5 Billion by 2010 from US$ 7.5 Billion in 2005.
* Over 60% of the insulin sold in 2006 was sold in pen devices.
* Insulin pen devices dominate the market in Europe and Japan whereas syringes and pumps dominate the US market.
* There was a big improvement in the global diabetes market for innovation particularly in the field of non-invasive methods of insulin delivery, including inhalable, oral and patch technology. [http://www.marketresearch.com/product/display.asp?productid=1491639&g=1 Source]
* There are 3 key new OAD classes; PPAR agonists, GLP-1 agonists/DPP IV inhibitors, and amlinomimetic agents. High forecasted sales are anticipated in 2011 for the GLP-1 agonist Exenatide LAR and the DPP-IV inhibitor Galvus at $2,902.9m and $1,228.7m, respectively. [http://www.marketresearch.com/product/display.asp?productid=1286835&g=1 Source]

[[Image:Diabetic market data.jpeg|thumb|center|800 px|]]

A. [http://www.globalbusinessinsights.com/content/rbhc0159m.pdf Competitive dynamics of the leading players in the global diabetes market, 2005]
B. [http://www.globalbusinessinsights.com/content/rbhc0159m.pdf Global diabetes market share by geography, 2005]]
C. [http://www.bccresearch.com/editors/RB-158.html Worldwide Diabetes Market, 2000, 2001, 2002 and 2007]
D. [http://www.globalbusinessinsights.com/content/rbhc0126m.PDF Global* market share of leading insulins (%), 1999-2003]

==Product Information==

[[Image:diabetes4.jpg|800 px|center|thumb| Overall categorization of diabetes treatments]]

===Products: Oral Hypoglycemic Agents===
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|bgcolor = "#FFFF00" colspan = "4"|Oral Hypoglycemic Agents
|-
|bgcolor = "#CCFFFF"|'''Drug'''
|bgcolor = "#CCFFFF"|'''Brand'''
|bgcolor = "#CCFFFF"|'''Company'''
|bgcolor = "#CCFFFF"|'''Availability'''
|-
|colspan = "4" | '''Sulfonylureas'''
|-
|'''First Generation'''
| 
| 
| 
|-
|Acetohexomide
|Dymelor
|Eli Lilly
|US, F, G, I, S,UK, J
|-
|Chlorpropamide, Tolazamide
|Diabenase
|Pfizer
|US, F, G, I, S,UK, J
|-
|'''Second Generation'''
| 
| 
| 
|-
|Glyburide (Glibenclamide)
|Diabeta
|Aventis
|US, F, G, I, S,UK, J
|-
|Glyburide (Glibenclamide)
|Micronase
|Pharmacia
|US, F, G, I, S,UK, J
|-
|Glyburide (Glibenclamide)
|Glynase
|Pharmacia
|US, F, G, I, S,UK, J
|-
|Glypizide
|Glucotrol, Glucotrol XL
|Pfizer
|US, F, G, I, S,UK, J
|-
|'''Third Generation'''
| 
| 
| 
|-
|Glimepride
|Amaryl
|Aventis
|US, F, G, I, S,UK, J
|-
|colspan = "4" |'''Meglitnides'''
|-
|Repaglinide
|Prandin
|Novo Nordisk
|US, F, G, I, S,UK, J
|-
|Nateglinide
|Sralix
|Novartis
|US,UK, J
|-
|colspan = "4" |'''Biguanides'''
|-
|Metfromin
|Glucophage, Glucophage XR
|Bristol-Myers Squibb
|US
|-
|Metfromin
| 
| 
| 
|-
|colspan = "4" |'''Thiazolidinediones'''
|-
|Rosiglitazone
|Avandia
|Glaxosmithkline
|US, G, UK
|-
|Pioglitazone
|Actos
|Takeda/ Eli Lilly
|US, UK, G, S, J
|-
|colspan = "4" |'''Alfa-Glucosidase Inhibitors'''
|-
|Acarbose
|Precose
|Bayer
|US, F, G, I, S,UK, J
|-
|Miglitol
|Glyset
|Pharmacia
|US, F, G, S
|-
|Voglibose
|Basen, Volix, Vogseal
|Ranbaxy, Nihon Pharmaceutical Industry Ltd
|I, J
|-
|colspan = "4"|'''Dipeptidyl peptidase-4 (DPP-4) inhibitor'''
|-
|Sitgliptin
|Januvia
|Merck
|US
|-
|}

===Products: Fixed Drug Combinations===
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|align = "center" colspan = "4"|'''Fixed Drug Combinations'''
|-
|bgcolor = "#CCFFFF"|'''Brand Name'''
|bgcolor = "#CCFFFF"|'''Drug 1'''
|bgcolor = "#CCFFFF"|'''Drug 2'''
|bgcolor = "#CCFFFF"|'''Company'''
|-
|Metaglip
|Glipizide
|Metformin
|Bristol-Myers Squibb
|-
|Duetact
|Glimepiride
|Pioglitazone
|Takeda
|-
|Avandaryl
|Glimepiride
|Rosiglitazone
|GlaxoSmithKline
|-
|ACTOSPlusMet
|Pioglitazone
|Metformin
|Takeda
|-
|Avandamet
|Rosiglitazone
|Metformin
|GlaxoSmithKline
|-
|Janumet
|Sitgliptin
|Metformin
|Merck
|-
|}

===Product pipeline===

[[Image:Roche.jpg|thumb|center|600px|]]
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|align = "center" bgcolor = "#FFFF99" colspan = "3" |'''Product Pipeline'''
|-
|align = "center" bgcolor = "#FFCC99"|'''Drug'''
|align = "center" bgcolor = "#FFCC99"|'''Company'''
|align = "center" bgcolor = "#FFCC99"|'''Stage'''

|-
|align = "center" colspan = "3"|'''Dipeptidyl Peptidase IV (DPP-IV) Inhibitor ''':DPP-IV inactivates glucagon-like peptide-1 (GLP-1), an important mediator of blood glucose levels following meals. DPP-IV inhibitors have been clinically shown to provide long term improvement of glucose control without the risk of hypoglycemia, and to improve the function of pancreatic beta cells, the cells responsible for the production of insulin.

|-
|align = "center"|ALS 2-0426
|align = "center"|[http://www.amgen.com/investors/pipe.jsp Alantos Pharmaceuticals, Amgen, Servier]
|align = "center"|1

|-
|align = "center"|PSN9301
|align = "center"|[http://www.osip.com/PSN9301 OSI]
|align = "center"|2

|-
|align = "center"|SYR-322
|align = "center"|[http://findarticles.com/p/articles/mi_m0RSB/is_2006_Jan_21/ai_n16017480 Takeda]
|align = "center"|3

|-
|align = "center"|R1579
|align = "center"|[http://www.roche.com/home/investors/inv_pipeline/inv_pipeline_det.htm?ta=Metabolism&Phase=%25&submit=Show+pipeline Roche]
|align = "center"|1

|-
|align = "center"|vildagliptin (Galvus)
|align = "center"|[http://www.pharma.us.novartis.com/newsroom/pressReleases/releaseDetail.jsp?PRID=1984 novartis]
|align = "center"|NDA submitted in March 2006

|-
|align = "center"|MP-513
|align = "center"|[http://www.m-pharma.co.jp/cgi-bin/pageview.cgi?pass=/e/develop/situation.html Mitsubishi Pharma]
|align = "center"|2

|-
|align = "center"|Gastrin <nowiki>+</nowiki> DPP IV Inhibitor
|align = "center"|[http://www.transitiontherapeutics.com/technology/index.php Transition Therapeutics]
|align = "center"|Preclinical

|-
|align = "center"|Saxagliptin
|align = "center"|[http://www.bms.com/research/content/data/pipeline.html Otsuka Pharmaceutical Co, Bristol-Myers Squibb]
|align = "center"|3

|-
|colspan = "3"|'''Insulin sensitizer'''

|-
|align = "center"|ISIS 113715
|align = "center"|[http://www.isispharm.com/product_pipeline.html Isis]
|align = "center"|3

|-
|align = "center"|NCX 4016 (Nitric Oxide donating derivative of Acetyl Salicylic acid)
|align = "center"|[http://www.nicox.com/update/NCX_4016.html NicOx]
|align = "center"|2

|-
|align = "center"|DG070 inhibitors
|align = "center"|[http://www.develogen.com/en/prod_pipeline.php?hnav=2&tnav=0 Develogen AG]
|align = "center"|Preclinical

|-
|align = "center"|NovoNorm® (repaglinide)/Metformin
|align = "center"|[http://www.novonordisk.com/science/pipeline/rd_pipeline.asp?showid=6 Novo Nordisk]
|align = "center"|3

|-
|colspan = "3"|'''Biguanides'''
|-
|-

|-
|align = "center"|Gastrin <nowiki>+</nowiki> Metformin
|align = "center"|[http://www.transitiontherapeutics.com/technology/index.php Transition Therapeutics]
|align = "center"|1

|-
|colspan = "3"|'''GLP 1 Analogue / Agonists''' GLP 1 Analogues have to be injected subcutaneously, Emisphere is working on an oral analogue

|-
|align = "center"|Abiglutide (716155)
|align = "center"|[http://www.gsk.com/investors/product_pipeline/docs/pipeline.pdf glaxosmithkline]
|align = "center"|2
|-
|align = "center"|TH0318
|align = "center"|[http://www.drugresearcher.com/news/ng.asp?id=58974-new-diabetic-drug Theratechnolgies]
|align = "center"|1

|-
|align = "center"|Liraglutide (NN2211)
|align = "center"|[http://www.novonordisk.com/science/pipeline/rd_pipeline.asp?showid=4 Novo Nordisk]
|align = "center"|3

|-
|align = "center"|R1583
|align = "center"|[http://www.roche.com/home/investors/inv_pipeline/inv_pipeline_det.htm?ta=Metabolism&Phase=%25&submit=Show+pipeline Roche]
|align = "center"|2

|-
|align = "center"|Oral GLP
|align = "center"|[http://www.emisphere.com/product_pipeline.asp Emisphere Technologies]
|align = "center"|1

|-
|align = "center"|PC-DAC™:Exendin-4
|align = "center"|[http://conjuchem.hyphenhealth.com/ ConjuChem]
|align = "center"|2

|-
| 
|align = "center"|[http://www.bms.com/research/content/data/pipeline.html Bristol-Myers Squibb ]
|align = "center"|Exploratory development

|-
|align = "center"|AVE0001A
|align = "center"|[http://en.sanofi-aventis.com/rd/portfolio/p_rd_portfolio_metabo.asp Sanofi Aventis]
|align = "center"|2

|-
|align = "center"|Gastrin <nowiki>+</nowiki>GLP 1 Agonist
|align = "center"|[http://www.transitiontherapeutics.com/technology/index.php Transition Therapeutics]
|align = "center"|2

|-
|colspan = "3"|'''Peroxisome Proliferator-Activated Receptor (PPAR) agonist/analogue'''

|-
|align = "center"|CS-011 (Rivoglitazone)
|align = "center"|Sankyo
|align = "center"|2

|-
|align = "center"|Metaglidasen(MBX 102)
|align = "center"|[http://www.medicalnewstoday.com/articles/26017.php Metabolex]
|align = "center"|2

|-
|align = "center"|MBX-2044
|align = "center"|[http://www.metabolex.com/pipeline.html Metabolex]
|align = "center"|1

|-
|align = "center"|AVE8134
|align = "center"|[http://en.sanofi-aventis.com/rd/portfolio/p_rd_portfolio_metabo.asp Sanofi Aventis]
|align = "center"|2

|-
|align = "center"|AVE0897
|align = "center"|[http://en.sanofi-aventis.com/rd/portfolio/p_rd_portfolio_metabo.asp Sanofi Aventis]
|align = "center"|1

|-
|align = "center"|R1439, aleglitazar
|align = "center"|[http://www.roche.com/home/investors/inv_pipeline/inv_pipeline_det.htm?ta=Metabolism&Phase=%25&submit=Show+pipeline Roche]
|align = "center"|2

|-
|align = "center"|AVE0847
|align = "center"|[http://en.sanofi-aventis.com/rd/portfolio/p_rd_portfolio_metabo.asp Sanofi Aventis]
|align = "center"|2

|-
|align = "center"|SAR351034
|align = "center"|[http://en.sanofi-aventis.com/rd/portfolio/p_rd_portfolio_metabo.asp Sanofi Aventis]
|align = "center"|Preclinical

|-
|align = "center"|376501
|align = "center"|[http://www.gsk.com/investors/pp_pipeline_standard.htm Glaxosmithkline]
|align = "center"|1

|-
|align = "center"|625019
|align = "center"|[http://www.gsk.com/investors/pp_pipeline_standard.htm Glaxosmithkline]
|align = "center"|1

|-
|align = "center"|677954
|align = "center"|[http://www.gsk.com/investors/pp_pipeline_standard.htm Glaxosmithkline]
|align = "center"|2

|-
|align = "center"|Avandia
|align = "center"|[http://www.gsk.com/investors/pp_pipeline_standard.htm Glaxosmithkline]
|align = "center"|2

|-
|align = "center"|Avandia XR
|align = "center"|[http://www.gsk.com/investors/pp_pipeline_standard.htm Glaxosmithkline]
|align = "center"|2

|-
|align = "center"|PPAR Gamma Agonist <nowiki>+</nowiki> simvaststin
|align = "center"|[http://www.gsk.com/investors/pp_pipeline_standard.htm Glaxosmithkline]
|align = "center"|3

|-
|align = "center"|MCC-555, Netoglitazone
|align = "center"|[http://www.m-pharma.co.jp/cgi-bin/pageview.cgi?pass=/e/develop/situation.html Mitsubishi Pharma, Novartis]
|align = "center"| 

|-
|align = "center"|Muraglitzar
|align = "center"|[http://www.drugs.com/nda/muraglitazar_041223.html Bristol-Myers Squibb ]
|align = "center"|3

|-
|align = "center"|R483
|align = "center"|[http://www.roche.com/pages/downloads/investor/pdf/praesentations/irp050504rdd14.pdf Roche]
|align = "center"|2

|-
|align = "center"|PPM-204
|align = "center"|[http://www.wyeth.com/research/pipeline Wyeth], [http://www.invitrogen.com/downloads/Discovery_Inhibitor_Oncogenic_B-RAF.pdf Plexxikon]
|align = "center"|2

|-
|colspan = "3"|'''Oral glucokinase activator (GKA)'''

|-
|align = "center"|PSN010
|align = "center"|[http://www.osip.com/PSN010 OSI]
|align = "center"|1

|-
|align = "center"|R1511
|align = "center"|[http://www.roche.com/home/investors/inv_pipeline/inv_pipeline_det.htm?ta=Metabolism&Phase=%25&submit=Show+pipeline Roche]
|align = "center"|1

|-
|colspan = "3"|'''G protein-coupled Receptor(GPR) 119 Agonist'''

|-
|align = "center"|PSN821
|align = "center"|[http://www.osip.com/PSN010 OSI]
|align = "center"| 

|-
|colspan = "3"|'''Antisense drug for Glucagon Receptor (GCGR)'''

|-
|align = "center"|ISIS 325568
|align = "center"|[http://www.isispharm.com/product_pipeline.html Isis]
|align = "center"|1

|-
|colspan = "3"|'''Antisense drug for Glucocorticoid Receptor (GCCR)'''

|-
|align = "center"|ISIS 377131
|align = "center"|[http://www.isispharm.com/product_pipeline.html Isis]
|align = "center"|Preclinical

|-
|colspan = "3"|''' Sodium Glucose Transporter 2 (SGLT2) inhibitor'''

|-
|align = "center"|AVE2268
|align = "center"|[http://en.sanofi-aventis.com/rd/portfolio/p_rd_portfolio_metabo.asp Sanofi Aventis]
|align = "center"|2

|-
|align = "center"|SAR 7226
|align = "center"|[http://en.sanofi-aventis.com/rd/portfolio/p_rd_portfolio_metabo.asp Sanofi Aventis]
|align = "center"|Preclinical

|-
|align = "center"|189075
|align = "center"|[http://www.gsk.com/investors/product_pipeline/docs/pipeline.pdf Glaxosmithkline]
|align = "center"|2

|-
|align = "center"|869682
|align = "center"|[http://www.gsk.com/investors/product_pipeline/docs/pipeline.pdf Glaxosmithkline]
|align = "center"|2

|-
|colspan = "3"|'''Growth hormone releasing analogue'''

|-
|align = "center"|TH 9507
|align = "center"|[http://www.theratech.com/en/products-therapeutic-peptides/pipeline.php Theratechnolgies]
|align = "center"| 

|-
|colspan = "3"|'''Nitric oxide (NO) blocking agent'''

|-
|align = "center"|NOX-700
|align = "center"|[http://www.medinox.com/news/press.htm Medinox]
|align = "center"|1 staretd in 2002

|-
|colspan = "3"|'''Antibody'''

|-
|align = "center"|TRX4
|align = "center"|[http://www.btgplc.com/PartneredDevelopment/240/TRX4.html BTG]
|align = "center"|2

|-
|colspan = "3"|'''Selective inhibitor of fructose-1, 6-bisphosphatase (FBPase)'''
|-
|align = "center"|CS-917
|align = "center"|[http://www.mbasis.com/pipeline/metabolic_disease.html Sankyo,Metabasis]
|align = "center"|2

|-
|align = "center"|MB07803
|align = "center"|[http://www.mbasis.com/pipeline/index.html metabasis, Daiichi Sankyo]
|align = "center"|2

|-
|colspan = "3"|'''11-beta hydroxysteroid dehydrogenase type 1 (11ß-HSD1) inhibitor'''

|-
|align = "center"|AMG 221
|align = "center"|[http://wwwext.amgen.com/science/pipe_AMG221.html Amgen, Biovitrum]
|align = "center"|1

|-
|colspan = "3"|'''Polypyrimidine tract binding protein (PTB, also named hnRNP) inhibitor'''

|-
|align = "center"| 
|align = "center"|Serono
|align = "center"|1
|-
|colspan = "3"|'''Insulin Like Growth Factor 1'''
|-
|-
|align = "center"|IPLEX (Mecasermin rinfabate)
|align = "center"|Glen Allen
|align = "center"|Orphan Drug Status

|-
|colspan = "3"|'''Newer Meglitinides'''
|-
|-
|align = "center"|Nateglinide with insulin sensitizers
|align = "center"|[http://www.astellas.com/global/about/news/2006/pdf/061130_eg.pdf Astellas pharmas]
|align = "center"|SNDA Filed

|-
|align = "center"|Nateglinide with biguanides
|align = "center"|[http://www.astellas.com/global/about/news/2006/pdf/061130_eg.pdf Astellas pharmas]
|align = "center"|SNDA Filed

|-
|colspan = "3"|'''Islet Regeneration Factors'''
|-
|-
|-
|align = "center"|DG770 (beta cell regeneration factor)
|align = "center"|[http://www.develogen.com/en/prod_pipeline.php?hnav=2&tnav=0 Develogen AG]
|align = "center"|3

|-
|align = "center"|E1 INT (Islet regeneration)
|align = "center"|[http://www.transitiontherapeutics.com/technology/index.php Transition Therapeutics]
|align = "center"|2

|-
|bgcolor = "#FFFF99" colspan = "3"|'''Miscellaneous'''

|-
|align = "center"|AMG 837 (Potentiates Glucose Dependent Insulin Secretion)
|align = "center"|[http://www.amgen.com/science/pipe_amg837.html Amgen]
|align = "center"|1

|-
|align = "center"|MBX 213
|align = "center"|[http://www.metabolex.com/pipeline.html Metabolex]
|align = "center"|1

|-
|align = "center"|R 1499
|align = "center"|[http://www.roche.com/pages/downloads/investor/pdf/praesentations/irp050504rdd14.pdf Roche]
|align = "center"|1

|-
|align = "center"|R1438
|align = "center"|[http://www.roche.com/pages/downloads/investor/pdf/praesentations/irp050504rdd14.pdf Roche]
|align = "center"|2

|-
|align = "center"|R1440
|align = "center"|[http://www.roche.com/pages/downloads/investor/pdf/praesentations/irp050504rdd14.pdf Roche]
|align = "center"|2

|-
|align = "center"|PSN 357
|align = "center"|OSI
|align = "center"|1

|-
|align = "center"|NBI 6024
|align = "center"|Neurocrine Biosciences
|align = "center"|2

|-
|align = "center"|MK 0941
|align = "center"|[http://www.merck.com/finance/pipeline.swf Merck]
|align = "center"|1

|-
|align = "center"|MK 1642
|align = "center"|[http://www.merck.com/finance/pipeline.swf Merck]
|align = "center"|1

|-
|align = "center"|Mk 0533
|align = "center"|[http://www.merck.com/finance/pipeline.swf Merck]
|align = "center"|2

|-
|align = "center"|MK0893
|align = "center"|[http://www.merck.com/finance/pipeline.swf Merck]
|align = "center"|2

|-
|align = "center" bgcolor = "#FFFF99" colspan = "3"|'''Insulins'''

|-
|align = "center"|Oral Insulin
|align = "center"|[http://www.emisphere.com/pc_oi.asp Emisphere Technologies]
|align = "center"|2

|-
|align = "center"|Technosphere
|align = "center"|[http://www.mannkindcorp.com/technosphere_insulin.aspx Mannkind corporation]
|align = "center"|3

|-
|align = "center"|NN344 (Insulin analogue)
|align = "center"|[http://www.novonordisk.com/science/pipeline/rd_pipeline.asp?showid=18 Novo Nordisk]
|align = "center"|1

|-
|align = "center"|NN5401(Insulin analogue)
|align = "center"|[http://www.novonordisk.com/science/pipeline/rd_pipeline.asp?showid=19 Novo Nordisk]
|align = "center"|1

|-
|align = "center"|AERx® iDMS (Insulin Inhalation system)
|align = "center"|[http://www.novonordisk.com/science/pipeline/rd_pipeline.asp?showid=5 Novo Nordisk]
|align = "center"|3

|-
|align = "center"|Inhaled insulin
|align = "center"|Bristol Meyers Squibb
|align = "center"|1

|-
|align = "center"|Inhaled insulin
|align = "center"|[http://investor.lilly.com/pipeline.cfm Eli Lilly]
|align = "center"|2

|-
|align = "center"|Exubera (Inhaled insulin)
|align = "center"|[http://www.pfizer.com/research/cardiovascular_condition.jsp Pfizer]
|align = "center"|4

|-
|align = "center"|Oal Lyn (Inhaled insulin)
|align = "center"|[http://www.generex.com/products/oral-lyn/ http://www.generex.com/products/oral-lyn/]
|align = "center"|Approved in Ecuador

|-
|align = "center"|Nasulin
|align = "center"|[http://www.bentleypharm.com/other/pipeline Bentley]
|align = "center"|2

|}

==Intellectual Property==
===Search strategy===
* '''Database/Vendor:''' Micropat
* '''Search scope:''' US Granted US Applications EP-A EP-B WO JP (bibliographic data only) DE-C,B DE-A DE-T DE-U GB-A FR-A; '''English Title'''
* '''Years:''' '''Issue/Publication Date:''' >20051231
* '''Search String:''' (Diabetes OR diabetic) AND (treatment OR treating)
* '''Hits:''' 618/217 patents (with/with out family members)
* '''Date of search:''' 11 July 2007

===Top players and IPC classes===

[[Image:Diabetes- top players.jpeg|center|800 px|]]

====IPC code definition====

{|border="0" cellspacing="1" width="80%"
|'''A61K'''
|Preparations for medical, dental, or toilet purposes
|-
|'''C07D'''
|Heterocyclic compounds
|-
|'''C07K'''
|Peptides
|-
|'''C12N'''
|Micro-organisms or enzymes; compositions thereof
|-
|'''C12Q'''
|Measuring or testing processes involving enzymes or micro-organisms (immunoassay); compositions or test papers therefor; processes of preparing such compositions; condition-responsive control in microbiological or enzymological processes
|-
|}

===Geographical Distribution and Treatment Approaches===

[[Image:Diabetes -geographical.jpeg|center|800 px|]]

===IP activity and Treatment Approaches===
* Decline in the IP activity during 2005 and 2006 is due 18 months publication delay of patent document.
[[Image:Diabetes -year approach.jpeg|center|800 px|]]

==Clinical Trials==
===Approved/On-going===
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|align = "center" bgcolor = "#FFFF99" colspan = "5"|'''Clinical trials'''
|-
|align = "center"|'''Drug'''
|align = "center"|'''Sponsors'''
|align = "center"|'''Description'''
|align = "center"|'''Phase'''
|align = "center"|'''Date of Start'''
|-
|align = "center" colspan = "5"|'''Oral Drugs'''
|-
|align = "center" colspan = "5"|'''Cannabinoid receptor antagonist'''
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00478595?order=1 Rimonabant]
|align = "justify"|Sanofi-Aventis
|align = "justify"|The primary objective of this study is to assess the efficacy of SR141716 (rimonabant) compared to placebo on change in HbA1c and on relative change in body weight over 52 weeks in obese type 2 diabetic patients on monotherapy inadequately controlled with oral anti-diabetic drug (sulfonylurea or ?-glucosidase inhibitor).
|align = "center"|3
|align = "center"|May-07
|-
|align = "center" colspan = "5"|'''Insulin Sensitisers'''
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00353587?order=24 Metaglidasen]
|align = "justify"|Metabolex
|align = "justify"|
|align = "center"|2, 3
|align = "center"|May-06
|-
|align = "center" colspan = "5"|'''Thioglitazone'''
|-
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00386100?order=1 Rosiglitazone maleate/metformin hydrochloride (AVANDAMET)]
|align = "justify"|GlaxoSmithKline
|align = "justify"|This study will evaluate the longer-term glycemic effect of two medicines approved for initial treatment of type 2 diabetes.
|align = "center"|4
|align = "center"|Oct-06
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00515632?order=8 Balaglitazone]
|align = "justify"|Rheoscience A/S
|align = "justify"|Balaglitazone is a thiazolidinedione derivative that is being developed as an oral anti-diabetic drug to improve blood glucose control in patients with type 2 diabetes. The purpose of this study is to assess if additional treatment with balaglitazone in patients with type 2 diabetes on stable insulin treatment will improve blood glucose control and decrease the daily insulin dose, but with less impact on weight gain and oedema.
|align = "center"|3
|align = "center"|Jul-07
|-
|align = "center" colspan = "5"|'''(DPP-4) inhibitor'''
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00351884?order=18 Vildagliptin]
|align = "justify"|Novartis
|align = "justify"|This is a 24-week study to assess the efficacy on HbA1c of 100 mg vildagliptin once daily as compared to placebo as add-on to metformin in patients with type 2 diabetes inadequately controllled with metformin.
|align = "center"|3
|align = "center"|May-06
|-
|align = "center" colspan = "5"|'''Insulin'''
|-
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00419562?order=1 Oral Insulin]
|align = "justify"|NIDDK, NICHD, NIAID, NICR, ADA, JDRF
|align = "justify"|N/A
|align = "center"|3
|align = "center"|Feb-07
|-
|align = "center" colspan = "5"|'''Potassium Channel Blocker'''
|-
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00131755?order=1 Diazoxide]
|align = "justify"|Grill, Valdemar, M.D.
|align = "justify"|The purpose of this study is to find out if Diazoxide can partly retain insulin production in newly diagnosed type 1 diabetes patients.
|align = "center"|4
|align = "center"|Feb-05
|-
|align = "center" colspan = "5"|'''Nutritional Agents'''
|-
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00117026?order=1 Benfotiamine (Vitamin B1)]
|align = "justify"|University Hospital, Aker, The Research Council of Norway
|align = "justify"|N/A
|align = "center"|1, 2
|align = "center"|Aug-05
|-
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00333554?order=1 Docosahexaenoic acid (DHA)]
|align = "justify"|NIDDK
|align = "justify"|N/A
|align = "center"|2
|align = "center"| June 2006
|-
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00400491?order=1 Vitamin D]
|align = "justify"|University of Tromso
|align = "justify"|The purpose of the study is to evaluate if supplementation with vitamin D in a dose of 40.000 IU per week will result in improved metablic control in patients with type 2 diabetes.
|align = "center"|2
|align = "center"|Jun-06
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00351234?order=25 Carnitine Supplementation]
|align = "justify"|Children<nowiki>’</nowiki>s Mercy Hospital Kansas City,Sigma Tau Pharmaceuticals, Inc, Minimed Pharmaceuticals, Pharmacia/Upjohn Career Development Award
|align = "justify"|The purpose of this study is to determine whether type I diabetics with carnitine deficiency exhibit increased numbers of hypoglycemic (low blood sugars) events and if unrecognized hypoglycemia occurs during continuous 72-hour glucose monitoring. If they are determined to have unrecognized hypoglycemia, then oral carnitine supplementation will be given to those subjects and they will be reassessed for the number of hypoglycemic events in a 72-hour glucose monitoring.
|align = "center"|
|align = "center"|Oct-04
|-
|align = "center" colspan = "5"|'''Antiinflammatory'''
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00339833?order=63 Salsalate]
|align = "justify"|NIDDK,National Institutes of Health Clinical Center
|align = "justify"|This study, conducted at the Phoenix Indian Medical Center, Phoenix, Arizona, will determine whether reducing subclinical inflammation lessens insulin resistance in healthy, obese volunteers.
|align = "center"|4
|align = "center"|Mar-03
|-
|align = "center" colspan = "5"|'''Angiotensin (AT 2) Antagonist/blocker'''
|-
|align = "justify"| Olmesartan
|align = "justify"|Daiichi Sankyo Inc
|align = "justify"|N/A
|align = "center"|3
|align = "center"|Oct-04
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00422487?order=35 MBX-2044]
|align = "justify"|Metabolex
|align = "justify"|The purpose of this study is to collect important information regarding the glucose-lowering efficacy of MBX-2044 and the safety of MBX-2044 (especially weight gain and edema) in diabetics. It will also provide important information about the appropriate doses to be used in subsequent longer-term studies to evaluate the safety and efficacy of MBX-2044 alone and in combination with other anti-diabetic agents.
|align = "center"|2
|align = "center"|Oct-06
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00473525?order=39 PF-00734200]
|align = "justify"|Pfizer
|align = "justify"|The purpose of this Phase 2a study is to evaluate the efficacy, safety and tolerability, of multiple parallel doses of PF-00734200 following oral administration to adult human subjects with T2DM who currently are on a stable dose of metformin.
|align = "center"|2
|align = "center"|Jun-07
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00391196?order=41 CP-945,598]
|align = "justify"|Pfizer
|align = "justify"|The purpose of this study is to determine if CP-945,598 is effective in the treatment of obesity in type 2 diabetic patients
|align = "center"|3
|align = "center"|Nov-06
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00147745?order=46 WelChol® (colesevelam)]
|align = "justify"|Daiichi Sankyo Inc
|align = "justify"|This study is designed to assess the potential mechanism of action by which WelChol® (colesevelam) may improve blood glucose control in patients with type 2 diabetes
|align = "center"|2
|align = "center"|May-05
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00461006?order=61 Aleglitazar and Actos®]
|align = "justify"|Hoffmann-La Roche
|align = "justify"|This study will compare the effects of aleglitazar and Actos®, added to preexisting oral antihyperglycemic therapy and/or diet and exercise, on renal function in patients with type 2 diabetes, and normal or mildly impaired renal function.
|align = "center"|2
|align = "center"| June 2007
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00328172?order=67 BI 1356 BS]
|align = "justify"|Boehringer Ingelheim Pharmaceuticals
|align = "justify"|The objective of this monotherapy study is to investigate the efficacy, safety, and tolerability of 3 doses of BI 1356 BS compared to placebo over 12 weeks of treatment in patients with type 2 diabetes and insufficient control of thier blood glucose. In addition, there will be an open-label treatment arm with metformin. The hypothesis of the trial is that the test drug, BI 1356 BS will lead to better control of blood glucose compared to placebo after 12 weeks of treatment.
|align = "center"|2
|align = "center"|May-06
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00357370?order=84 BMS-512148]
|align = "justify"|Bristol-Myers Squibb
|align = "justify"|The purpose of this clinical research study is to learn if BMS-512148, added to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone), can help reduce the blood sugar levels compared to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone) alone, in subjects with type 2 diabetes.
|align = "center"|2, 3
|align = "center"| October 2006
|-
|align = "center" colspan = "5"|'''Parenteral routes'''
|-
|align = "center" colspan = "5"|'''Insulins'''
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00349986?order=3 Insuline glargine]
|align = "justify"|Sanofi-Aventis
|align = "justify"|Purpose ogf this study is to determine rhe first dose and titration of basal insulin
|align = "center"|4
|align = "center"|May-06
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00360698?order=2 Basal Insulin Plus Insulin Glulisine]
|align = "justify"|Sanofi-Aventis
|align = "justify"|To evaluate the efficacy of a single injection of glulisine before the main meal added to insulin glargine plus oral antidiabetic drugs (OADs) compared to insulin glargine plus OADs in Type 2 diabetic patients poorly controlled with basal insulin plus OADs.
|align = "center"|4
|align = "center"|Jul-06
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00282971?order=10 Inhaled Insulin (Exubera)]
|align = "justify"|Pfizer
|align = "justify"|To assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes who are not well controlled on 2 or more oral anti-diabetic agents
|align = "center"|3
|align = "center"|Mar-06
|-
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00325364?order=1 Insulin Inhalation Powder]
|align = "justify"|Eli Lilly and Company
|align = "justify"|This is a phase 3, open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected pre-meal insulin in non-smoking patients with type 2 diabetes. Patients will be treated for 24 months with a 2-month follow-up period.
|align = "center"|3
|align = "center"|Apr-06
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00455858?order=51 Levemir]
|align = "justify"|Novo Nordisk
|align = "justify"|This trial aims for a comparison of the effect on glycaemic control in subjects with type 2 diabetes under both established Western algorithm and Korean practical algorithm, given in combination with oral diabetic drug(s)
|align = "center"|4
|align = "center"|Aug-07
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00228878?order=69 Pulsatile IV Insulin]
|align = "justify"|Florida Atlantic University
|align = "justify"|The purpose of this study is to determine if restoring normal metabolic function in patients with either type I or type II diabetes can improve the impact of the consequences of diabetic complications on the overall quality of life of diabetic patients. Patients are treated once a week with pulsatile intravenous insulin therapy mimicking normal insulin secretion.
|align = "center"|2, 3
|align = "center"|Mar-03
|-
|align = "center" colspan = "5"|'''Incretin Minetic'''
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00360334?order=9 Exenatide With Basal Insulin]
|align = "justify"|Amylin Pharmaceuticals, Eli Lilly
|align = "justify"|This is a phase 3 trial designed to compare the effects of twice daily exenatide plus oral antidiabetic agents (OADs) and once-daily insulin glargine plus OADs with respect to glycemic control, as measured by hemoglobin A1c, with minimum weight gain, in patients with uncontrolled type 2 diabetes on OADs.
|align = "center"|3
|align = "center"|Jun-06
|-
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00456300?order=1 Exenatide]
|align = "justify"|Baylor College of Medicine, NIH
|align = "justify"|The purpose of this study is to see if giving exenatide and insulin before a meal would lower blood sugars after the meal.
|align = "center"|4
|align = "center"|Mar-07
|-
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00434954?order=11 Exenatide Plus Metformin vs. Insulin Aspart Plus Metformin]
|align = "justify"|Amylin Pharmaceuticals, Eli Lilly
|align = "justify"|This study in Germany is designed to compare the effects of twice-daily exenatide plus metformin and twice-daily premixed human insulin aspart plus metformin with respect to glycemic control, as measured by HbA1c, combined with the percentage of patients with at least one treatment-emergent hypoglycemic episode. Patients will be treated with study therapy for approximately 26 weeks.
|align = "center"|3
|align = "center"|Feb-07
|-
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00451113?order=1 Sitigliptin]
|align = "justify"|Merck Frosst Canada Ltd, University of British Columbia
|align = "justify"|
|align = "center"|2
|align = "center"|Nov-06
|-
|align = "center" colspan = "5"|'''Antibodies'''
|-
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00129259?order=1 hOKT3gamma1 (Ala-Ala)]
|align = "justify"|NIAID
|align = "justify"|hOKT3gamma1 (Ala-Ala) is a man-made antibody that is commonly used to prevent organ rejection. The purpose of this study is determine whether hOKT3gamma1 (Ala-Ala) can halt the progression of newly diagnosed type 1 diabetes.
|align = "center"|2
|align = "center"|Sep-05
|-
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00279305?order=1 Anti-CD20 (rituximab)]
|align = "justify"|NIDDK, NICHD, NIAID, NICR, ADA, JDRF
|align = "justify"|This study will investigate the use of rituximab to see if it can help lower the number of immune B cells thereby preventing the destruction of any remaining insulin producing beta cells that remain at diagnosis.
|align = "center"|2, 3
|align = "center"|Dec-06
|-
|align = "center" colspan = "5"|'''Surgical'''
|-
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00303134?order=1 Islet Cell Transplants]
|align = "justify"|Weill Medical College of Cornell University
|align = "justify"|
|align = "center"|1
|align = "center"|Aug-03
|-
|}

==Conferences==
* [http://www.keystonesymposia.org/Meetings/ViewMeetings.cfm?MeetingID=922 Diabetes Mellitus, Insulin Action and Resistance] at Breckenridge, Colorado from January 22 - 27, 2008
* [http://www.diabetes.org.uk/Professionals/Conferences_and_events/Annual-Professional-Conference-2008/ Diabetes UK Annual Professional Conference 2008] at Glasgow from 05 Mar 2008 09:00 to 07 Mar 2008 17:00
* [http://www.conferencealerts.com/seeconf.mv?q=ca13a3h0 7th International Diabetes Federation Western Pacific Region Congress] at Wellington, New Zealand on 30 Mar 2008.
* [http://debussy.hon.ch/cgi-bin/confevent?aff2+CONF07692+Diabetes_Mellitus 1st International Conference on Advanced Technologies & Treatments for Diabetes] at Czech Republic during 27 Feb to 01 Mar 2008.
* [http://www.goingtomeet.com/conventions/details/5301 Discovery Strategies Conference: Modeling Human Metabolic Syndrome and Type 2 Diabetes in Rodents] at Us during Aug-05-2007.
* [http://www.goingtomeet.com/conventions/details/15113 7th International Conference for Clinical Endocrinology,Diabetes and Infertility] at Egypt during Sep-06-2007.
* [http://www.diabetes.ca/section_professionals/confindex.asp CDA/CSEM Professional Conference and Annual Meetings] at British Columbia during October 24-27, 2007.

===Conference Update: [http://www.diabetes.org/home.jsp American Diabetic Association 2007] ===
==== Conference highlights for Oral Hypoglycemic Agents ====

# [[Oral_Diabetes_Drugs#Products:_Oral_Hypoglycemic_Agents|Oral hypoglecemic agents]] and their role in diabetes treatment. The focus was the recent meta analysis published in [http://content.nejm.org/cgi/content/full/356/24/2457?ijkey=9288cc5edfcb35c1e7f1bd5d974d1169d64cea0b NEJM], showing increase CV mortality with Rosiglitazone. The panel consensus was that while awaiting more safety data, for now those patients who are tolerating Rosiglitazone should continue taking them, whereas newly diagnosed patients should try alternative treatment. Also all PPAR agonists should be treated as distinct entities rather than having class effect.
# 12 different [[Oral_Diabetes_Drugs#Products:_Oral_Hypoglycemic_Agents| diabetes products]] are in various stages of development, and there were about 55 abstracts talking about DPP–IV inhibitors. They are especially useful for:
#* The elderly
#* Those with renal insufficiency
#* Heart failure patients
#[http://www.amylin.com/pipeline/symlin.cfm Amyline] analogue (Pramlinitide) was combined with Insulin for treatment of Type 2 DM and results were favorable.
# Continuous glucose monitoring using implanted glucose sensors is a step forward in evolving technology. Yet it is still very expensive and best for highly trained patients on intensive insulin therapy.