Pharma Blog Watch

GSK to Challenge Merck's Gardasil (QDIS Blog)
In his blog, Ed Vawter discusses GlaxoSmithKline's (GSK) plan to challenge Merck's Gardasil in a head-to-head study. "Merck's Gardasil is already approved and on its way towards $700 million in sales it first year. GSK on the other hand won't even submit an [application] until at earliest 2009 and so will be at least three years behind."

"Another problem is that the proposed study is only 1,000 patients and some, including myself, wonder if this will even allow you to see if there is a difference," he writes. "Also GSK is taking a shortcut and making the argument that testing the response generated by the immune system due to the vaccine will be an indicator that the vaccine works better and longer. This has not been proven to be the case, and the FDA in general frowns on such approaches."

"It will definitely be an uphill battle and I see the likely outcome being the FDA asking for longer term data on how well it protects against cervical cancer and precancerous lesions. This would set back GSK by years. It is a risky gambit."