Glaxo Falters Again
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laxoSmithKline announced today that the U.S. Food and Drug Administration wants more information on its cervical-cancer vaccine called Cervarix before clearing it for sale, giving Merck & Co. more time before a rival comes to market. As you may know, Merck was first to market with its highly touted (and somewhat controversial) cervical cancer vaccine called Gardasil. Both vaccines protect against infections with certain human papilloma virus (HPV) strains that cause over 99.9% of all cases of cervical cancer. Gardasil targets four strains of HPV - including two causing cancer and two causing genital warts, while Cervarix targets only the two cancer strains.
According to Ed Silverman at Pharmalot, “the FDA has issued a so-called ‘complete response letter’ for its Cervarix vaccine. Although it’s not clear, though, whether the agency wants additional trials, leaving open the possibility that the unexpected delay in approval can last anywhere from just six months to up to two years.”
As you may recall, Merck was actively lobbying state and federal legislators earlier this year to make Gardasil vaccination mandatory for girls aged 12 and older. I find it interesting that the agency is questioning Cervarix’s approvability given Merck previous and extremely vigorous lobbying campaign for mandatory vaccination with Gardasil. “executives shouldn’t blame their problems on FDA being slow to green light new medicines”. Thank you for the insight Mr. Clark!
GSK has high hopes for Cervarix expecting it to be a billion-dollar-a-year product. FDA’s decision to delay approval of Cervarix is more bad news for GSK which has taken big revenue hit because of safety concerns with its anti-diabetes drug Avandia. Look for continued right-sizing at GSK.
Until next time….
Good Luck and Good Job Hunting!!!!!!!
laxoSmithKline announced today that the U.S. Food and Drug Administration wants more information on its cervical-cancer vaccine called Cervarix before clearing it for sale, giving Merck & Co. more time before a rival comes to market. As you may know, Merck was first to market with its highly touted (and somewhat controversial) cervical cancer vaccine called Gardasil. Both vaccines protect against infections with certain human papilloma virus (HPV) strains that cause over 99.9% of all cases of cervical cancer. Gardasil targets four strains of HPV - including two causing cancer and two causing genital warts, while Cervarix targets only the two cancer strains. According to Ed Silverman at Pharmalot, “the FDA has issued a so-called ‘complete response letter’ for its Cervarix vaccine. Although it’s not clear, though, whether the agency wants additional trials, leaving open the possibility that the unexpected delay in approval can last anywhere from just six months to up to two years.”
As you may recall, Merck was actively lobbying state and federal legislators earlier this year to make Gardasil vaccination mandatory for girls aged 12 and older. I find it interesting that the agency is questioning Cervarix’s approvability given Merck previous and extremely vigorous lobbying campaign for mandatory vaccination with Gardasil. “executives shouldn’t blame their problems on FDA being slow to green light new medicines”. Thank you for the insight Mr. Clark!
GSK has high hopes for Cervarix expecting it to be a billion-dollar-a-year product. FDA’s decision to delay approval of Cervarix is more bad news for GSK which has taken big revenue hit because of safety concerns with its anti-diabetes drug Avandia. Look for continued right-sizing at GSK.
Until next time….
Good Luck and Good Job Hunting!!!!!!!
