"Llegó el autobús": CERVARIX (ahora ya para mujeres)/ GARDASIL (ahora ya para hombres)...

“Cervarix is approved in many markets outside of the U.S. already” where it has “approximately 35 percent sales market share,” said Tim Anderson, an analyst at Sanford C. Bernstein & Co. in New York, in a note to clients last week. “In the U.S., the product will be roughly three years behind Gardasil’s introduction, and our belief is that it will not capture as much share in the U.S. as it has internationally.”

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The FDA is scheduled to make a decision by the end of this month whether to approve Cervarix’s use in women ages 10 to 25. The shot is cleared in 98 countries and had sales of 125 million pounds ($232 million) last year, or about one-sixth as much as Gardasil. The average estimate of three analysts surveyed by Bloomberg calls for sales of 758 million pounds in 2012.

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Merck had sought approval to sell Gardasil to prevent pre- cancerous lesions in boys and young men, as well as genital warts. The FDA told the company in May the proposal for prevention of “external genital lesions” was too broad, according to the FDA’s staff review.

This restriction may hurt Merck’s ability to prove the shot is cost effective for boys, said Keyur Parekh, a UBS AG analyst in New York, in a Sept. 4 note to clients.

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