FDA Denies ViroPharma's Vancocin Petition

It was revealed on Tuesday that the U.S. Food and Drug administration has denied a petition by ViroPharma VPHM related to determining bioequivalence for it's ,ega-selling drug Vancocin. As a result, VPHM is seeking an injunction to block the FDAs approval of three generic versions of the drug. The market has reacted quickly to the news, with ViroPharma shares down 20% at $22.80, although the stock is still up 48% over the past 12 months. VPHM believes that the FDA is incorrectly interpreting standards related to the approval of bioequivalent products and, in addition, it is concerned about the fact that a December supplemental approval for Vancocin will not qualify the drug for three additional years of exclusivity. To rub salt into those already expansive wounds, the FDA approved the Akorn AKRX and Watson Pharmaceuticals WPI generic versions of the drug. Premarket trading saw AKRX shares up 4.4% at $12.20. WPI shares closed on Monday at $66.59. The analysts are obviously concerned. In a research report published on Tuesday, Piper Jaffray said that AKRX's generic will compete directly with ViroPharma's Vancocin, which achieved sales of $289 million in 2011. This brings risk to Piper's current branded Vancocin sales forecasts of $310 million in 2012, $375 million in 2013 and $403 million in 2014. Vancocin sales grew 14.7% to $77.8 million in 4Q:11, totaling $289 million in 2011.