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DIABETES: ASSESSING THE COMPETITIVE POTENTIAL OF EMERGING THERAPIES
CRG "Drugs in Pipeline" Series
Diabetes:
Assessing the Competitive Potential of Emerging Therapies
Executive Summary
Diabetes has been described as the epidemic of the 21st century, currently impacting the lives of more than 200 million people worldwide. Obesity, an important risk factor for diabetes, is growing at even a faster pace and likely to further increase the prevalence of diabetes.
The upshot is that payers already shelling out hundred of billions of dollars to treat diabetes will continue to embrace new therapies and treatments. And that spells opportunities for biotech and pharmaceutical investing in new solutions to these growing problems.
But which drugs in pipeline have the best prospects for success? And which pose the biggest competitive threat to existing—bestselling—diabetes drugs?
Diabetes: Assessing the Competitive Potential of Emerging Therapies is the latest installment in the CRG Drugs in Pipeline series. Written by leading pharmaceutical industry analysts Boas Gonen, M.D., a founder of BioPharma Guide and Ron Notvest, Ph.D., MBA, a founder of Evidec, this 200-page report provides has expert assessment of the prospect of diabetes drugs in the development.
New 100-Point Rating System
Many dozens of different drugs in development will be reviewed and rated on a scale of 1 to 100, using a newly developed proprietary algorithm which takes into account published information on product attributes, all of which are known to have an impact on the probability of success for a compound. The algorithm will include both qualitative and quantitative data, to address the following questions:
Preclinical data
Is the preclinical model validated or known to be predictive?
Is there in vivo data available?
Is the pharmacological target relevant to the pathogenesis?
Clinical data
Has proof-of-concept been demonstrated?
Has the inherent safety been demonstrated?
Target validation
Has the molecular target been validated?
Has the safety been validated?
Regulatory Importance
Is the compound known to be designated fast track?
Is the compound receiving a priority review?
Is there a highly significant medical need?
Likelihood of commercial success
How differentiated is the product and will there be high demand?
Success of other compounds in the class
Are there any approved products in this class?
If so, are they differentiated?
Rating Drugs in Development and Assessing How the Competition Stacks Up
With the results of our proprietary 100-Point Rating System as a basis, this report will analyze all of the drugs in clinical development among both U.S. and international drug manufacturers, including Big Pharma, biotech, publicly traded companies, privately firms and start-ups. Our analysis will encompass treatments for Type II Diabetes, Type I Diabetes, Diabetic Complications and Obesity.
- Type II Diabetes treatment to be rated will include…
Insulins and analogues
Injectable (Oral/Buccal, Inhaled, Other)
GLP-1 and related compounds
DPP-IV inhibitors
PPAR activators
Fructose 1.6 bipshosphatase inhibitors
PTP-1B inhibitors
11beta-HSD1
Sodium-Glucose Reuptake Cotransporter-2 inhibitors
AMP Kinase activators
GK activators
Others
Natural products and diet supplements
- Type I Diabetes treatment to be rated will include…
Immune-modulators
Stem Cells, Islet transplants
Others
- Obesity treatments to be rated will include…
Centrally acting agents
Peripherally acting agents
The State of the Art of Diabetes Development
The report will also provide an insightful overview of the strengths and weaknesses of existing treatments and players in the market for diabetes drugs, including…
- Medical overview on diabetes and obesity: types, epidemiology, pathophysiology, manifestations, complications.
- Current status of anti-diabetic therapy
Available therapies
Insulins
Non-insulin injectables (e.g. Symlin, Byetta)
Oral (e.g. Sulphonyl-ureas; Metformin; PPAR-ã agonists, CHO absorption inhibitors, Insulin stimulators, DPP IV inhibitors)
- Current status of anti-obesity therapy
- In depth analysis of recent setbacks in anti-diabetic/anti-obesity drugs
Profiles of Pharmaceutical, Biotech Firms in the Diabetes Space
The profiles will cover ~100 companies, including the following: Akesis, AmbRx, Arena, Bentley, Biodel, Biovitrum, Conjuchem, CytRx, Diamyd, Depomed, Diobex, Emisphere, Genaera, Generex, Incyte, Insulet, Isis, Kinemed, Lexicon, Merck, Metabolex, Metabasis, Microislet, Neurogen, Novartis, Novo-Nordisk, Nutrition 21, Opexa, Oramed, Orexigen, Phenomix, Protemix Transition, Vivus.
Who will benefit from reading this report?
- Pharmaceutical companies: Executives, Scientists, Business development personnel
- Managed care companies: senior executives, reimbursement managers
- Investment companies: fund managers, VC partners
- Individual biotech investors
- Health care providers: General physicians, endocrinologists
About the Authors
Boas Gonen M.D.
Dr. Gonen has more than 25 years experience in academic medicine and the pharmaceutical industry. A board certified endocrinologist (sub-specialty in diabetes and lipid metabolism), Dr. Gonen has wide academic research experience and pharmaceutical drug development experience. Most recently (since 1999) Dr. Gonen was involved in pharmaceutical consulting in clinical and business development (as president of Pharmagon). He has reviewed and analyzed hundreds of compounds in development.
Ron Notvest Ph.D. MBA
Dr. Notvest has over 20 years of pharmaceutical industry experience discovering, developing and marketing pharmaceutical products. In 2002, Dr. Notvest founded Evidec to address the commercial needs of small to mid-sized biopharmaceutical companies by providing commercial assessments, marketing support and market planning services. He has conducted assessments in a broad range of therapeutic areas, and has developed proprietary models to quantify the commercial potential of drug development assets.
Table of Contents
Chapter 1: Executive Summary—The Diabetes Epidemic, Problems and Solutions
Chapter 2: The State of the Art in Diabetes Treatment—A Review of Current Drugs
Chapter 3: Rating Drugs in Development—A Proprietary 100-Point Algorithm
Chapter 4: Profiles of Pharmaceutical, Biotech Firms in the Diabetes Space
About Corporate Research Group
Corporate Research Group has been serving the healthcare marketplace for 14 years as the industry's leading source for breaking news, strategic intelligence, market research and custom consulting.
CRG products consist of print and electronic newsletters, e-mail updates, annual forecasts, webinars, and the unique Managed Care Access online information service. CRG’s various information products include the Managed Healthcare Market Report, HSA Market News, Outlook for Managed Care, and various print and electronic databases and special reports.
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