WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Aug. 8, 2006--Merck & Co., Inc. announced today that JANUVIA(TM) (sitagliptin phosphate) has been approved in Mexico as an oral, once-daily medicine for type 2 diabetes. This approval is the first in the world for a new class of oral drugs for type 2 diabetes (dipeptidyl peptidase-4 (DPP-4) inhibitors) that enhances the body’s own ability to lower blood sugar (glucose) when it is elevated. The mechanism of action of DPP-4 inhibitors is distinct from that of any currently available class of glucose-lowering agents.
Mexico is the first country in the world to grant regulatory approval to JANUVIA. JANUVIA remains an investigational product in the United States. The New Drug Application (NDA) for JANUVIA has been accepted for standard review by the U.S. Food and Drug Administration, and Merck expects FDA action on the NDA by mid-October. The Company is also moving forward as planned with regulatory filings in various countries around the world.
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.
JANUVIA(TM) is the proposed trademark for MK-431 (sitagliptin phosphate).
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.
Contact: Media: Amy Rose, 908-423-6537 Tracy Ogden, 267-305-0960 OR Investors: Graeme Bell, 908-423-5185
Source: Merck & Co., Inc.
