FDA Issues 2nd Complete Response Letter for Merck's (MRK) GARDASIL; Reaffirms FY09 Sales, EPS Guidance

January 9, 2009 8:50 AM EST

Merck & Co., Inc. (NYSE: MRK) announced today that the U.S. FDA has issued a second complete response letter regarding the supplemental biologics license application for the use of GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant] in women ages 27 though 45.

The agency has completed its review of the response that Merck provided in July 2008 and has recommended that Merck submit additional data when the 48 month study has been completed. The initial sBLA included data collected through an average of 24 months from enrollment into the study, which is when the number of pre-specified endpoints had been met. Following a review of the final results of the study, Merck anticipates providing a response to the agency in the fourth quarter of 2009. The letter does not affect current indications for GARDASIL in females ages 9 through 26 nor does the letter relate to the sBLA that was submitted in December 2008 for the use of GARDASIL in males.

Merck reconfirmed its 2009 total sales guidance of $23.7-$24.2 billion. The Company also reconfirmed its full-year 2009 non-GAAP EPS range of $3.15-$3.30, excluding certain items. The Street is currently expecting FY09 sales of $24.08 billion and non-GAAP EPS of $3.27.

Merck & Co., Inc. provides products for human and animal health in the United States and internationally.

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