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Biologics License Application for Gardasil(R), Merck's Investigational Cervical Cancer Vaccine, Is On Track

Posted on: Thursday, 2 February 2006, 18:01 CST

Merck & Co., Inc. announced today that the U.S. Food and Drug Administration (FDA) Biologics License Application (BLA) for GARDASIL(R) (quadrivalent human papillomavirus types 6, 11, 16, 18, recombinant vaccine) is on track and pending acceptance. Merck delivered the completed file to the FDA on December 1. Following the submission, the FDA informed Merck that the submission date is officially December 8. Within 60 days following official submission, the FDA will determine whether it will accept for review Merck's application as submitted.

About Merck

Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.

Forward-Looking Statement

This press release, including the financial information that follows, contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the cautionary statements in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2004, and in its periodic reports on Form 10-Q and Form 8-K, which the Company incorporates by reference.

Source: Business Wire

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