Licensing Opportunities: Neurology
Decision Resources, Inc, April 2010, Pages: 35
The future of drug discovery and development will be modeled on extensive cooperation and collaboration between multiple academic, government, non-profit, and industry stakeholders—not on the individual R&D silos that pharmaceutical companies have instituted until very recently. Neurological drug discovery and development will benefit significantly from this new approach, given the intractable and complex nature of neurological diseases. Large and small pharmaceutical and biotech companies are turning to one another as sources of needed licensing, partnering, or acquisitions. To understand the landscape and dynamics of the neurology industry, we looked at different types of companies that are active in the neurology therapy area, analyzed their drug development and commercialization activities, and explored potential opportunities.
Questions Answered in This Report:
- In 2008, the central nervous system (CNS) market was the second largest therapy market (after the top-ranked cardiovascular market), totaling $87 billion in worldwide pharmaceutical sales. Who were the major players in this market in 2008? Who will be the major players in 2015? What are the major brands and their worldwide sales? What late-stage drugs that will launch soon are expected to achieve significant commercial success?
- Partnering and in-licensing are becoming a way of life for small and large companies alike. Which Big Pharma, Midsize Pharma, and small biotech/neuroscience companies are active in neurology? What are the major brands in company neurology portfolios? What neurology agents are in development in the pipelines of these companies?
- Many opportunities exist for generics competitors to challenge neurology patents and bring therapeutic equivalents to market as soon as they can. Which eight neurology brands recently went off patent, and which generics companies have received FDA approval to market generic equivalents? What is the status of authorized neurology generics and pay-for-delay deals for neurology drugs?
Scope:
- Expert commentaries: Peter Wittner of Interpharm Consultancy on the activities of midsize European pharma companies and Big Pharma companies that are active in neurology drug markets and neurology R&D; insights on the Alzheimer’s disease market from Matthew Winton, Ph.D., a Decision Resources analyst specializing in central nervous system diseases.
- Primary data: Results from a survey of 29 U.S. neurologists on the impact of Dimebon’s clinical trial failure on the Alzheimer’s disease drug market; forecasted market size and sales of neurology brands from Decision Resources analysts.
- Neurology markets: Major players; brands with worldwide sales of more than $500 million; market size; projected growth of specifi c disease market segments; maturation of Sanofi -Aventis’s neurology portfolio.
- Neurology pipelines: Competition from drugs soon to launch; recent late-stage failures; leading company pipelines by number of agents by disease; soon-to-launch drug candidates with potential worldwide sales of more than $300 million in 2015; vaccines in development for Alzheimer’s disease.
- Major neurology players: Analysis of the neurology interests of more than 15 small neuroscience/ biotechnology companies, 13 Midsize Pharma companies, 20 generics companies, and 10 Big Pharma companies; generics companies; European and Japanese pharmaceutical companies active in neurology; marketed neurology drugs; neurology drug candidates in development; existing partners; companies looking for partners.
- Generics companies: Authorized generics for certain neurology drugs; pay-for-delay deals; patent litigation settlement deals; more than 40 generics companies approved to market 8 recently expired neurology brands.
- Outlook: Five insights on opportunities in the neurology therapy area; an emerging model of extensive cooperation and collaboration in basic research, drug discovery, and development.
Key Terms for This Report:
Alzheimer’s disease, Central and Eastern Europe, Collaboration, Commonwealth of Independent States, Epilepsy, Licensing, Midsize Pharma, Migraine, Multiple sclerosis, Parkinson’s disease, Partnering, Restless legs syndrome, Sleep disorders, Strategic planning, Stroke
Executive Summary
Strategic Considerations
Stakeholder Implications
Looking for Opportunities
Forecast Market Growth, 2008 to 2015
Major Brands in Neurology Markets
Near-Term Competition from Drugs in Late-Stage Development
Late-Stage Clinical Development Setbacks
Small Company R&D Activities in Neurology
AC Immune
Addex Pharmaceuticals
Allon Therapeutics
Avineuro Pharmaceuticals
D-Pharm
Intellect Neurosciences
Neurocrine Biosciences
NeuroNova
NeuroSearch
Newron Pharmaceuticals
Phytopharm
Prana Biotechnology
Raptor Pharmaceuticals
Sygnis Pharma
TauRx Therapeutics
Potential Partners
Big Pharma
Midsize European Pharma
Almirall
Chiesi Farmaceutici
H. Lundbeck
Merck KGaA
Recordati
Midsize Japanese Pharma
Astellas Pharma
Dainippon Sumitomo
Eisai
Kyowa Hakko Kirin
Mitsubishi Tanabe Pharma
Midsize Biotech
Biogen Idec
Cephalon
Genzyme
Generic Opportunities
Generics Companies Manufacturing and Selling Neurology Drugs
Near-Term Generics Opportunities
Agreements Between Pharma and Generics Companies
Outlook
Expert Commentaries
Peter Wittner, principal, Interpharm Consultancy
- Potential Partners: Big Pharma
- Potential Partners: Midsize European Pharma
Matthew Winton, Ph.D., Decision Resources analyst specializing in central nervous system diseases
- Assessing the Impact of Dimebon’s Clinical Trial Failure on the Alzheimer’s Disease Drug Market
Tables
1. Neurological Brands with Worldwide Sales of $500 Million or More, 2008 and 2015
2. Neurological Drug Candidates with Potential Worldwide Sales of $300 Million or More, 2015
3. Vaccines in Development for Alzheimer’s Disease
4. Generics Companies with FDA Approval to Market Select Neurology Drugs
5. Authorized Generics in the United States for Select Neurology Drugs
6. Neurology: Major Players in R&D or with Marketed Drugs
Figures
1. Leading Neurology Pipelines, Number of Agents by Disease, Mid 2009
2. Maturation of Sanofi -Aventis’s Neurology Portfolio, 2008 to 2015
- Abbott Laboratories
- AC Immune
- Accord Healthcare
- Acorda Therapeutics
- Actavis
- Actelion
- Addex Pharmaceuticals
- Affi ris
- Alembic
- Allon Therapeutics
- Almirall
- Alpharm
- Amneal Pharmaceuticals
- Anchen Pharmaceuticals
- Apotex
- App Pharmaceuticals
- Astellas Pharma
- Aurobindo Pharma
- Avineuro Pharmaceuticals
- Barr Laboratories
- Bayer
- Bayer Schering Pharma
- Bedford Laboratories
- Bejing Yabao
- Biogen Idec
- Boca Pharma
- Boehringer Ingelheim
- Britannia Pharmaceuticals
- Centre Hospitalier Universitaire d’Angers
- Cephalon
- CHDI Foundation
- Chiesi Farmaceutici
- Cilag
- Cipla
- Cobalt Laboratories
- CorePharma
- CSL
- Cypress Pharmaceutical
- Cytos Biotechnology
- D-Pharm
- Dainippon Sumitomo
- Dr. Reddy’s Laboratories
- Edison Investment Research
- Eisai
- Elan
- Eli Lilly
- European Medicines Agency
- Food and Drug Administration (FDA)
- Forest Laboratories
- Fumapharma
- Genentech
- Genzyme
- GlaxoSmithKline
- GlaxoSmithKline Biologicals
- Glenmark Generics
- GW Pharmaceuticals
- H. Lundbeck
- Huahai US
- Impax Laboratories
- Intellect Neurosciences
- Interpharm Consultancy
- Invagen Pharmaceuticals
- Janssen
- JHP Pharmaceuticals
- Johnson & Johnson
- Kyowa Hakko Kirin
- Lupin Therapeutics
- Meda
- Medivation
- Memory and Aging Center, University of California, San
Francisco (UCSF)
- Menarini
- Merck & Co.
- Merck KGaA
- Merck Serono
- Merz
- Mitsubishi Tanabe Pharma
- Mutual Pharmaceutical
- Mylan
- Neurocrine Biosciences
- NeuroNova
- NeuroSearch
- Newron Pharmaceuticals
- New York Academy of Sciences
- Novartis
- NuPharm
- Orchid Healthcare
- Ortho Biotech
- Otsuka Pharmaceutical
- Ovation Pharmaceuticals
- Par Pharmaceutical
- PDL BioPharma
- Pfi zer
- Pharmaceuticals and Medical Device Agency (PMDA)
- Phytopharm
- Prana Biotechnology
- Prasco Laboratories
- Ranbaxy Laboratories
- Raptor Pharmaceuticals
- Recordati
- Roche
- Roche Venture Fund
- The Rockefeller University
- Roxane Laboratories
- Saegis Pharmaceuticals
- Sandoz
- Sanofi -Aventis
- Sanofi -Synthélabo
- Servier
- Shire
- Silarx
- SK Bio Pharmaceuticals
- Solco Healthcare
- Spectrum Pharmaceuticals
- SR-One
- State University of Moscow
- Sun Pharmaceutical Industries
- Sygnis Pharma
- Taro Pharmaceuticals
- TauRx Therapeutics
- Teva Pharmaceutical Industries
- Tolmar
- Torrent Pharmaceuticals
- Torrex Chiesi Pharma
- TorreyPines Therapeutics
- U.S. Court of Appeals for the District of Columbia
- U.S. District Court for the District of Delaware
- U.S. Patent and Trademark Offi ce
- UCB
- Unichem Laboratories
- United Biomedical
- Upsher Smith
- U.S. Federal Trade Commission (FTC)
- Vernalis
- Vintage
- Wanbang Biopharmaceuticals
- Watson Laboratories
- Wockhardt
- Wyeth
- XenoPort
- YungJin Pharmaceuticals
- Zogenix
- Zydus Pharmaceuticals
- ZymoGenetics
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