EU panel backs Glaxo's cervical cancer vaccine
(Adds background on Merck product, further details)
LONDON, July 18 (Reuters) - GlaxoSmithKline Plc (GSK.L) won a green light for its cervical cancer vaccine, Cervarix, from European medical experts on Wednesday, paving the way for the launch of one of its biggest new product hopes.
Europe's largest drugmaker said an expert committee at the European Medicines Agency had given a positive opinion on Cervarix based on data from clinical trials involving the vaccination of girls and women aged between 10 and 25.
Recommendations for marketing approval by the agency's Committee for Medicinal Products for Human Use are normally endorsed by the European Commission within a couple of months.
The positive opinion is in line with guidance from UK-based Glaxo, which had said previously it expected to launch Cervarix in Europe in the second half of 2007. The European decision marks an important step forward for Cervarix, which won approval its first major market -- Australia -- in May.
Glaxo's vaccine will compete with U.S.-based Merck & Co. Inc.'s (MRK.N) Gardasil, which is already available in both in the United States and Europe, where it sold via a vaccines joint venture with France's Sanofi-Aventis SA (SASY.PA). Cervarix is not likely to go on sale in the key U.S. market before 2008.
Both vaccines protect against cancer-causing strains of the sexually transmitted human papillomavirus (HPV). They are expected to create a multibillion-dollar market, although most analysts think Merck's first-mover advantage will win it the lion's share.
((Reporting by Ben Hirschler, editing by Braden Reddall; email: ben.hirschler@reuters.com; Reuters Messaging: ben.hirschler.reuters.com@reuters.net; +44 20 7542 5082)) Keywords: GLAXO CERVARIX/
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