US advisers back Merck's cervical cancer vaccine

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http://today.reuters.com/business/newsarticle.aspx?type=tnBusinessNews & storyID=nN18398920 & imageid=top-news-view-2006-03-13-002938-eRPPISA%5B19%5D.jpg & cap=A%20general%20view%20shows%20a%20logo%20on%20the%20Merck%20facility%20in%20Rahway,%20New%20Jersey%20November%2028,%202005.%20%20REUTERS/Jeff%20Zelevansky UPDATE 3-US advisers back Merck's cervical cancer vaccine (Recasts throughout with details, reaction) By Richwine GAITHERSBURG, Md., May 18 (Reuters) - The first vaccine to protect young women and girls from a sexually transmitted virus that causes cervical cancer won unanimous support from U.S. advisers on Thursday, making approval likely next month. Women's health advocates hailed the vaccine as a major advance against a deadly disease, while industry

analysts said it could boost its struggling manufacturer, Merck & Co. Inc. <MRK.N>. Annual sales could top $2 billion, some said. Shares of Merck rose after the panel vote, closing up 2.3 percent to $35.13 on the New York Stock Exchange. The vaccine, named Gardasil, targets common types of the sexually transmitted human papilloma virus, or HPV, which causes genital and skin warts and most cervical cancer. About 300,000 women worldwide die from cervical cancer each year, including almost 4,000 in the United States. Members of the U.S. Food and Drug Administration advisory panel said they were persuaded by Merck's studies showing Gardasil shots prevented early-stage cervical cancer and precancerous lesions in women and girls ages 9 to 26. The FDA usually approves products endorsed by its advisory panels. Several panelists cautioned,

however, that the vaccine worked only against four HPV types and that women should still undergo regular screening for the disease. "It's not going to get rid of all cervical cancer. There are other HPV types that cause cancer," said Dr. Farley, the panel's chairwoman. A final FDA decision is expected by June 8, putting Merck ahead of a potential rival vaccine by GlaxoKline Plc <GSK.N> <GSK.L>. Merck officials said Gardasil would be available within a month of approval. Gardasil, given in three doses over six months, targets four HPV types believed to cause more than 70 percent of cervical cancer cases and 90 percent of genital warts. Protection has lasted five years in 500 females who have been monitored for that long, Merck officials said. Studies will continue to see if booster shots are needed. Merck said Gardasil could reduce

annual deaths from cervical cancer to about 90,000 if it were used globally. The company said it would have the greatest impact if given to girls before they become sexually active. HPV infection is common, hitting about half of sexually active adults sometime during their life, although it usually causes no symptoms. Dr. Bobbie Gostout, speaking for the Society of Gynecologic Oncologists, said the vaccine offered a rare chance to further cut deaths in the cases when it does cause cancer. "Not since the introduction of the (Pap) test over a half a century ago has such an opportunity existed," she told the panel. Pap tests, which can catch precancerous and cancerous cells early, cut U.S. cervical cancer deaths by 74 percent. Deutsche Bank analyst Barbara predicted the vaccine would post peak annual sales of up to $2 billion, revenues Merck badly needs to revive earnings

growth following the recall of its arthritis drug Vioxx and generic competition beginning next month for its Zocor cholesterol fighter. Merck also is studying Gardasil in older women and in males, who can transmit HPV to women or develop penile and other cancers from it. Merck and France's Sanofi-Aventis <SASY.PA> <SNY.N> would market Gardasil through a joint venture in Europe if it won clearance there. Merck licensed the vaccine technology from Australian company CSL Ltd. <CSL.AX>. Glaxo has said it plans to apply this year for U.S. approval of its HPV vaccine called Cervarix. Both Glaxo and Merck have filed applications for approval of the vaccines in Europe. (Additional reporting by Ransdell Pierson in New York)

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