Glaxo Gets ‘Standard’ FDA Review For Cervarix
Make a commentBy Ed Silverman // May 30th, 2007 // 3:27 pm
This is good news for Merck. Tim Anderson of Prudential Equity wrote an investor note this afternoon in which he says the drugmaker has received a “standard” 10-month review for Cervarix, its HPV vaccine. However, he doesn’t seem surprised.
“This is, essentially, in line with how Glaxo has been guiding recently, but there was the possibility that the company would get a six-month priority review, given the potential public health benefit of having a second product on the market,” he writes.
And so, “it may not be until the first quarter of 2008 that Merck’s Gardasil faces US competition, in line with what we currently model. (Outside the US), competition to Merck’s product will likely come during the current year in many territories.”