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

The first Phase 0 trial results, thefirst fruits of Japan's biosimilar pathway, the first straightforward use of the social marketing tool Twitter to advance a drug franchise, thefirst moves of the EU to regulate third-party mentions of pharmaceuticals, thefirst encounter with the H1N1 strain of infl uenza. Thesefirsts 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.

Questions Answered in This Report

• 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.

Please note, the PDF e-mail from publisher version of this report is for a global site license.