GlaxoSmithKline Plc won US approval on Friday to sell a cervical cancer vaccine for girls and young women, while a rival Merck & Co shot was cleared for preventing genital warts in males. Glaxo said the US Food and Drug Administration cleared the Cervarix vaccine for females ages 10 to 25.
Merck's competing cervical cancer vaccine, Gardasil, debuted on the US market in 2006 and generated some controversy over its cost and potential side effects. On Friday, the FDA approved Gardasil for preventing genital warts in boys and men ages 9 through 26.
Both vaccines fight two strains of the sexually transmitted human papillomavirus (HPV) that cause about 70 percent of cervical cancers. Gardasil also targets two other HPV strains that cause genital warts. It is unclear how long protection lasts or whether booster shots will be needed. Some analysts say it will be hard for Glaxo to compete against Merck's three-year head start in the US market. Glaxo's original bid in 2007 stalled when the FDA sought more data.
Cervarix got a boost on Friday by winning the first approval for a cervical cancer vaccine in Japan, the world's second-largest pharmaceutical market after the United States. Consensus forecasts suggest Cervarix will generate world-wide sales of just over $1 billion in 2013, according to Thomson Pharma, equivalent to about 2 percent of expected Glaxo sales for that year.
Merck's Gardasil had global sales of $1.4 billion in 2008. The company said Centers for Disease Control and Prevention advisory panel was expected to vote next Wednesday on whether to recommend Gardasil for males. Both Cervarix and Gardasil fight two HPV strains that cause about 70 percent of cervical cancers.
In Glaxo's studies, Cervarix was 93 percent effective in preventing a pre-cancerous condition associated with the two strains. Cervarix also fought some other strains. It was 89 percent effective in preventing precancerous lesions from the third most common HPV type to cause cancer, Glaxo said. Neither Gardasil nor Cervarix fights all types of HPV.
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