FDA Has Full Plate This Fall For Vaccines: More Than H1N1
This article was originally published in RPM Report
FDA faces the massive task of facilitaing the development and distribution of H1N1 vaccine in the autumn of 2009, but the agency also has some important pending applications for other vaccines in the same timeframe: Prevnar-13, Cervarix, and Gardasil for boys. Wall Street is not showing much excitement about the upcoming decisions. The applicatins could present some pleasant surprises and positive events for the sponsors.
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Two years after shaking up the vaccine field with its big entry-acquisition of Chiron, Novartis AG has identified a make-or-break pair of projects in the meningitis area. The meningitis vaccines will determine whether the Novartis bet on vaccines will turn into a smart long-term diversification or a low-return move into an unfamiliar and unfriendly segment of health care.
Given the near-term generic threats to over a third of its US drug revenues and two late-stage set-backs last year, Wyeth's vaccines business--basically the $3 billion-and-growing pneumococcal vaccine Prevnar--matters more than ever before. So, then, does eliminating an imminent competitive threat from GlaxoSmithKline, and a swift switch to follow-on Prevnar 13 in 2010. Indeed, vaccine chiefs at the other four big players-Sanofi-Aventis, Merck & Co. Inc., GlaxoSmithKline PLC, and Novartis AG-are likely to become more prominent, too. Vaccines may still account for only a small minority of revenues at these Big Pharma, but most saw far healthier growth in their vaccines business in 2007 than in therapeutics. That's why Sanofi, according to recent media reports, is out looking for vaccine acquisitions.
Wyeth's conjugated pneumococcal vaccine continues to break records. The company boldly says there is a lot of growth left, enough to take the product through $3 billion a year and perhaps to $4.5 billion. No vaccine has ever reached those heights. Can Wyeth pull it off?