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UPDATE 1-GSK says Cervarix effective against more viruses
By: AFX | 07 Jul 2009 | 02:24 AM ET
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LONDON, July 7 (Reuters) - GlaxoSmithKline Plc's Cervarix is the first product of its kind to show it protects against the five most common cervical cancer-causing viruses, Europe's biggest drug company said in a statement on Tuesday. A study, published in Tuesday's issue of The Lancet, said that as well as protecting against the two most common virus types, the vaccine also provides protection against the next three most common cancer-causing virus types. Glaxo said the additional efficacy could translate into approximately 11 to 16 percent extra protection against cervical cancer over and above the protection afforded by efficacy against the two most common types alone. It is the first time for any cervical cancer vaccine that significant protection has been shown against pre-cancerous lesions not containing the two most common virus types, Glaxo said in a statement. "This is really good news for primary prevention of cervical cancer as it indicates the vaccine could offer women additional protection ... beyond what had at first been anticipated," said Thomas Breuer, head of global clinical R&D at GSK Biologicals. BOYS AND MEN Cervarix and its rival Gardasil, produced by Merck & Co Inc's, are only approved for use in girls and women, but the companies are seeking new markets and some experts say it should be used in boys and men, to protect them and their future sexual partners. In comments accompanying the Cervarix study, the researchers said the only efficient way to stop the virus is to also vaccinate boys and men because they make up the other half of the sexually active population. "Women have shouldered responsibility for contraception since its inception. The goal to eradicate sexually transmitted carcinogenic viruses can be jointly carried by women and men and could be accomplished within a few decades," said Karin Michels from the Harvard Medical School in Boston and Harald zur Hausen from the German Cancer Research Centre in Heidelberg. Glaxo is waiting for approval in the U.S. market for Cervarix. U.S.

approval was delayed in June last year after Glaxo said it would augment its application with results from a further study after responding to outstanding questions over the product from the Food and Drug Administration. Cervarix is already approved in more than 90 countries including major European markets. (Reporting by Ben Deighton; Editing by David Holmes and Jon Loades-Carter) Keywords: GLAXOSMITHKLINE/CERVARIX (ben.deighton@reuters.com; +44 207 542 7009; ben.deighton.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2009. All rights reserved.

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