Biopharma Quarter: Key Trends and Events of the Second Quarter of 2009

Abstract

“Last quarter, we included Vanda Pharmaceuticals in our list of companies struggling for survival in the midst of the economic downturn. This quarter, we note Vanda' s success, not only because it signals a comeback but also because the company' s resurrection, made possible by the FDA' s approval of the company' s Fanapt brand of iloperidone, is a victory in the move toward personalized medicine. Vanda prevailed in its quest for Fanapt' s approval based on pharmacogenetically stratifi ed research showing the effi cacy of the drug in particular subgroups of patients; companion diagnostics to guide the use of Fanapt might reach the market as well. Personalized medicine is a pending new paradigm for healthcare and one of the trends that companies in the biopharma sector must monitor and consider in formulating their strategies.”- Catherine Cuddihee, M.S., Principal Director.

The first Phase 0 trial results, the first fruits of Japan' s biosimilar pathway, the first straightforward use of the social marketing tool Twitter to advance a drug franchise, the first moves of the EU to regulate third-party mentions of pharmaceuticals, the first encounter with the H1N1 strain of infl uenza. These firsts of the second quarter of 2009 are among the developments that companies in the biopharma sector should consider in the context of their business strategies. This report provides biopharma players with event- and trend-related alerts, explanations, and models to heed.

• Voices call for a healthcare paradigm shift toward personalized medicine. What does the approval of Vanda' s Fanapt teach contenders in this space? What hobbles the paradigm shift?
• Drug development is stymied by a variety of factors. How is the FDA transforming to facilitate R&D? How are scrutiny and regulation of the industry changing in major-market regions? What are the opportunities in niche diseases?
• Novo Nordisk took a big step in the social marketing arena with the launch of a Twitter-based campaign. How is the company using this medium? How does the campaign relate to conventional marketing wisdom? What are the related regulatory issues?
• Pharma industry dealmaking continues at a relatively steady state. What companies are among the big players? What are the notable deals of the second quarter of 2009? How has the H1N1 fl u pandemic infl uenced dealmaking?
• National governments have enacted measures to drive use of generics and biosimilars. What results have been recorded in the United States? In Japan? What effect has this focus had on the fortunes of generics companies?

Scope

• Events Perspective: Phase 0 trials, iloperidone approval, warfarin payment decision, FDA reform, orphan drug funding, DTC advertising, regulation, social marketing, Twitter.
• Deals Perspective: Deals compared with prior time periods; deals by company, therapeutic area, technology; deals focusing on H1N1 and stem cell technologies.
• Generics Perspective: Japanese biosimilars, leading generics companies, generics dealmaking, generics-based healthcare savings.
• Strategy Perspective: Focus on the H1N1 fl u (swine fl u) pandemic.
• Expert commentaries: Implications of Phase 0 clinical trials for oncology, orphan drug development strategies, opportunities for makers of infl uenza diagnostics.