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Licensing Opportunities: Neurology

Decision Resources, Inc., April 2010, Pages: 35


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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



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