Both Merck and GlaxoSmithKline face a big day in front of an FDA expert panel next week. Glaxo will be making its case for Cervarix, a widely used vaccine designed to guard against cervical cancer that's been blocked from the U.S. market. And Merck, which has been selling its HPV vaccine in the U.S. for three years, will be touting data that supports its argument for using Gardasil to protect boys.
For Merck a new indication would give the company a chance to build on its sales of the product at a time the market appears to be in decline. Second quarter sales of Gardasil slid 18 percent. And for Glaxo it's a chance to start selling Cervarix in the U.S. after it has already claimed a big market share in countries around the world.
Merck has already had to defend itself against some harsh criticism directed at its sales tactics. Any new approval for boys is likely to add fuel to the fire. Male cases are extremely rare, and while efficacy rates are high for Gardasil, Merck would have a hard time demonstrating whether its vaccine cuts the death rate among males. Glaxo for its part is just going to focus on competing for the female market, noting to FierceVaccines that vaccinating women is the most clinically and cost-effective way to help prevent cervical cancer while there is " no clinical data that show that vaccinating men protects women from cervical cancer-causing HPV strains."
. The FDA panel vote is likely to play a decisive role with the agency.
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