Glaxo's Cervarix Delayed by FDA

British drugmaker GlaxoSmithKline (GSK) received a "complete response" from the FDA in regard to approval of its cervical cancer vaccine, Cervarix. A complete response is issued when the FDA has finished reviewing a product but still has outstanding questions. Glaxo plans to address the FDA’s concerns as soon as possible; the delay places Glaxo squarely behind the team of Merck & Co. (MRK) and Sanofi-Aventis SA (SNY), who already have their cervical cancer vaccine, Gardasil, on the market in both the U.S. and the EU. European regulators approved Cervarix in September.

Trying to put a positive face on the latest news, Glaxo’s VP and Director of North American Vaccine Development, Dr. Barbara Howe said: "We have already started addressing the questions and will be engaged in discussions with the FDA to finalize our responses. Our discussions with the agency continue to be positive and constructive, and we are working diligently to resolve any outstanding questions to bring CERVARIX to the U.S. market.” The U.S. is the largest drug market in the world. Glaxo is trying to increase its share of the global cancer drug market, which is expected to jump from its current $35 billion to $66 billion by 2010. Analysts feel the delay will set back Cevarix’s entry to the U.S. market by as much as a year.

Sources: Press release, Bloomberg, Reuters, Dow Jones Newswires
Additional Reading: GlaxoSmithKline Q3 2007 Earnings Call Transcript

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Comments

[marcdoc]

GSK continues to lag behind Merck in all major vaccine initiatives (think Cervarix vs. Gardasil but also Rotarix vs. Rotateq). Approval 1-3 years behind major competitor makes the potential windfall much smaller if/when approval happens. Maybe they should just give up on the vaccine race since Merck has clearly figured out how to win.