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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 164 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.
CRG is a division of World Health
Holdings, organizer of the nationally acclaimed World Health Care Congress.
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