GSK seeks European approval for cervical cancer vaccine
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[March 10, 2006]

GSK seeks European approval for cervical cancer vaccine

(Comtex Business Via Thomson Dialog NewsEdge)Mar 10, 2006 (Datamonitor via COMTEX) --GlaxoSmithKline has submitted a marketing application for its keenly anticipated cervical cancer vaccine, Cervarix, in the European Union.

GSK's development of the vaccine is slightly behind that of Merck & Co., which submitted Gardasil, its own cervical cancer vaccine, for approval in Europe and the US at the tail end of last year.

GSK said that international regulatory filings for Cervarix will follow in Australia, parts of Asia and Latin America from March 2006, with submission to the FDA by the end of 2006.

Cervarix has been developed to prevent infection from the two most prevalent cancer-causing types of the human papillomavirus (HPV), specifically HPV 16 and 18, which together are responsible for over 70% of cervical cancer globally.

In clinical trials, Cervarix demonstrated 100% protection from persistent infection against both HPV 16 and HPV 18, and protection from precancerous lesions.

"We developed this vaccine with the ambition to provide all women with the best possible protection against cervical cancer throughout their life and are delighted with the progress we are making towards bringing the vaccine to market," commented Andrew Witty, president of GSK Pharmaceuticals Europe.



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