PRINCETON, N.J. and WHITEHOUSE STATION, N.J., Oct. 18 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company (NYSE:BMY) and Merck & Co., Inc. (NYSE:MRK) jointly announced today that the U.S. Food and Drug Administration (FDA) issued an approvable letter for PARGLUVA(TM) (muraglitazar), the companies' investigational oral medicine for the treatment of type 2 diabetes. The FDA has requested additional safety information from ongoing trials, or those completed since the safety data from the last formal regulatory submission, to address more fully the cardiovascular safety profile of PARGLUVA. The companies are eager to begin discussions with the FDA to address this issue and to determine what additional information may be necessary.
In early September, Bristol-Myers Squibb researchers presented the pre-clinical and clinical data to support the benefit-risk profile of PARGLUVA to the FDA's Endocrinologic and Metabolic Drugs Advisory Committee.
Bristol-Myers Squibb and Merck are collaborators in the global development and commercialization of PARGLUVA. The New Drug Application (NDA) for PARGLUVA was submitted to the FDA in late December 2004.
Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains certain forward-looking information within the meaning of the Private Securities Litigation Reform Act of 1995 regarding a product in development and the potential efficacy of such product that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainty of the success of the research and development activities; decisions by regulatory authorities regarding whether and when to approve any new drug application for a product candidate that may result from the research, as well as their decisions regarding labeling and other matters that could affect the commercial potential of such product candidate; and competitive developments. A further list and description of risks and uncertainties can be found in the Bristol-Myers Squibb's Annual Report on Form 10-K for the fiscal year ended December 31, 2004, and in its reports on Form 10-Q and Form 8-K. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
Merck 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 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: Bristol-Myers Squibb Company; Merck & Co., Inc.
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