Merck Receives Not Approvable Letter From FDA For MK-0524A (ER Niacin/laropiprant)

Main Category: Cholesterol
Also Included In: Regulatory Affairs / Drug Approvals;  Statins
Article Date: 30 Apr 2008 - 1:00 PDT

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Merck & Co., Inc. received a Not Approvable action letter from the U.S. Food and Drug Administration (FDA) for the Company's New Drug Application (NDA) for MK-0524A (ER niacin/laropiprant) for the treatment of primary hypercholesterolemia or mixed dyslipidemia.

"We plan to meet with the FDA and to submit additional information to enable the agency to further evaluate the benefit/risk profile of MK-0524A," said Peter S. Kim, Ph. D. executive vice president and president, Merck Research Laboratories.

"We firmly believe that MK-0524A provides physicians with an important option to manage their patients' cholesterol. We are encouraged that on April 24, the Committee for Medicinal Products for Human Use (CHMP) recommended marketing approval for MK-0524A in Europe, and we will continue to pursue approval within individual markets in the EU and around the world," added Dr. Kim.

Merck today also reaffirmed the Company's 2008 financial guidance as issued last week (see here) and reiterated Merck's confidence in meeting its goal of double-digit annual EPS growth through 2010 excluding certain items.

"Merck's broad portfolio of medicines and vaccines, including eight products in launch phase, enables us to weather challenges that come our way," said Richard T. Clark, chairman, president and chief executive officer, Merck. "The Company remains confident that we will grow our business this year and achieve the goals outlined in our plan to win."

In the FDA's letter, the agency rejected the proposed trade name CORDAPTIVE for MK-0524A. The Company said at the appropriate time it expects to pursue the alternative trade name TREDAPTIVE for use in the United States.

About Merck

Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck 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 http://www.merck.com.

Forward-Looking Statement

This press release 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 risk factors and cautionary statements in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2007, and in any risk factors or cautionary statements contained in the Company's periodic reports on Form 10-Q or current reports on Form 8-K, which the Company incorporates by reference.

http://www.merck.com