Healthcare Industry News:  metformin 

Biopharmaceuticals Endocrinology FDA

 News Release - July 31, 2006

Merck Announces FDA Acceptance of New Drug Application for MK-0431A, an Investigational Fixed Dose Combination of JANUVIA(TM) and Metformin for Type 2 Diabetes

WHITEHOUSE STATION, N.J.--(HSMN NewsFeed)--July 31, 2006--Merck & Co., Inc. today announced that the New Drug Application (NDA) for MK-0431A, the Company's investigational oral medicine combining JANUVIA(TM) (sitagliptin phosphate) with metformin for type 2 diabetes, has been accepted for standard review by the U.S. Food and Drug Administration (FDA). Merck expects FDA action on the NDA by the end of March 2007. The Company is also moving forward as planned with regulatory filings in countries outside the United States.

MK-0431A is an investigational treatment for type 2 diabetes that combines the novel approach to controlling blood sugar of JANUVIA, an investigational DPP-4 inhibitor, with metformin, a widely-prescribed medication for type 2 diabetes, into a single tablet. MK-0431A is designed to provide an important treatment option for patients who need two or more oral agents to help control their blood sugar.

The mechanism of action of DPP-4 inhibitors is distinct from that of metformin and all other drugs in the currently available classes of glucose-lowering agents. DPP-4 inhibitors work by enhancing the body's own ability to lower blood sugar (glucose) when it is elevated.

"The filing of MK-0431A demonstrates Merck's commitment to the treatment of serious diseases like type 2 diabetes," said Richard T. Clark, chief executive officer and president, Merck & Co., Inc. "The development programs for JANUVIA and MK-0431A are strong examples of Merck's strategy to develop innovative products."

"The majority of type 2 diabetes patients require multiple therapies to control their blood sugar," said Dr. Peter S. Kim, president, Merck Research Laboratories. "MK-0431A could potentially be the first fixed-dose tablet of a DPP-4 inhibitor combined with a widely used and long-standing mainstay of type 2 diabetes treatment, metformin."

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 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, 2005, and in its periodic reports on Form 10-Q and Form 8-K, which the company incorporates by reference.

JANUVIA(TM) is the proposed trademark for MK-431 (sitagliptin phosphate).


Source: Merck

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