<div><p>The Food and Drug Administration has updated the label of Merck's cervical cancer vaccine Gardasil, adding new information about its protective effects against two other gynecological cancers.</p><p>The new labeling indicates the vaccine also protects against cancers of the vagina and vulva, which affect more than 5,000 women in the U.S. each year, according to Merck.</p><p>The vaccine works by defending against four strains of the human papillomavirus, which cause the majority of cervical cancers. A Merck scientists said the virus accounts for a smaller portion of vaginal and vulvar cancers, though he added it plays a role in more than half of them.</p><p>"Anytime we have evidence of additional cancer protection, that's a really important piece of information," said Merck's Rick Haupt, executive director for HPV vaccines.</p><p>It was not immediately clear what the additional indication would mean for sales of the vaccine, which have fallen short of the company expectations.</p><p>Merck has already scaled back full-year sales estimates for Gardasil from between $1.9 billion and $2.1 billion to between $1.4 billion and $1.6 billion, following regulatory setbacks and challenges making inroads with young adult patients.</p><p>First approved in 2006, Gardasil is the only cervical cancer vaccine approved for the lucrative U.S. market, though Merck has had limited success expanding use.</p><p>The FDA rejected Merck's proposal in June to begin marketing the vaccine to women ages 27 to 45. It is currently approved for ages 9 to 26. The company's expansion effort seems even less likely after a government-funded study released last month concluded the roughly $375 vaccine is not cost-effective for women in their 20s and older.</p><p>Gardasil is outselling rival GlaxoSmithKline's Cervarix vaccine abroad. The Glaxo injection is still pending review at the FDA.</p><p>The positive announcement Friday breaks a string of FDA rejections for the Whitehouse Station, N.J.-based company. Earlier this year the agency denied applications to sell two new experimental cholesterol drugs and what would have been the first nonprescription cholesterol drug.</p><p>Shares of Merck & Co. Inc. fell 17 cents Friday to close at $33.82.</p><img src="http://admatch-syndication.mochila.com/images/ad.gif?aid=32890759&bid=informcom" /></div><div id="copyright"><div>

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