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Merck, Sanofi cancer vaccine wins European approval

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Merck & Co. won European Union approval to sell the first vaccine against a sexually transmitted virus that causes cervical cancer, challenging rival GlaxoSmithKline Plc on its home turf. European regulators have allowed Merck, the fourth-biggest US drugmaker, to start selling the shot, partner Sanofi-Aventis SA said in an e-mailed statement. It's the first vaccine specifically designed to prevent a cancer. Glaxo of London still awaits European regulators' decision on a similar product, called Cervarix. The vaccines target the human papillomavirus, or HPV, which causes genital warts as well as cervical cancer, the No. 2 malignancy among women worldwide. The approval, which took less than a year, opens a market of 25 countries. Gardasil may generate $3 billion in annual sales, according to Lehman Brothers. Merck considers the vaccine its most important product. „The market is large enough for two products but the sooner you're on the market the better,” Marie-Helene Leopold, a pharmaceuticals analyst at Societe Generale in Paris, said in a telephone interview on September 22. Merck and Paris-based Sanofi will introduce the vaccine toward the end of October in Germany, the UK and Scandinavia. Marketing in countries such as Italy may start early next year, said Didier Hoch, president of the companies' vaccine venture. „The fact that it has taken nine months for approval is a strong signal in the interest in the disease and the good quality of the research,” Hoch said.
The infectious disease vaccines market may swell to $18 billion by 2010, according to Wood Mackenzie Consultants Ltd. HPV is one of the most common sexually transmitted viruses in the world. Merck's vaccine targets four strains of HPV, two of which are responsible for 70% of cervical cancer cases. Research presented September 3 at a conference in Prague indicated the product may protect women against as many as six additional strains of HPV. Further trials are being conducted. Merck's vaccine has been approved for sale in the US, where the Whitehouse Station, New Jersey-based drugmaker has waged a consumer awareness campaign designed to help seed the market for the vaccine. As recently as 18 months ago, Merck's research showed that fewer than 20% of American women knew that HPV causes cervical cancer.
The campaign is also designed to help ease concerns among parents worried about adding another routine childhood vaccine. Glaxo, Europe's largest drugmaker, asked European regulators for permission to market its own HPV vaccine in Europe in May. The company funded a study, presented last month, that shows using Cervarix could reduce the number of cases and deaths from cervical cancer in the UK by up to 76%. The Merck approval „is welcome news in the fight against cervical cancer, and we hope for similar European approval for Cervarix in the H1 of 2007,” Glaxo said in an e-mailed statement. Gardasil is given in three shots over a six-month period at a cost of $120 each in the US American experts recommended that the shots be given to 11- and 12-year-old girls and repeated before age 26. US researchers said that the vaccine should be mandatory for preteen girls. Gardasil may be given to girls as young as 9, Sanofi said. The product has won approval in Canada, Australia, Brazil and Mexico. (Bloomberg)

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