PRINCETON, N.J., Dec. 23 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company today announced that the company submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for muraglitazar, an investigational agent under development for the treatment of patients with type 2 diabetes. Bristol-Myers Squibb and Merck & Co., Inc. are collaborators in the global development and commercialization of muraglitazar.
Muraglitazar, discovered by Bristol-Myers Squibb, has the potential to be the first in a novel class of drugs known as dual peroxisome proliferator activated receptor (PPAR) agonists to be approved for marketing in the U.S.
The company also provided an update on the rolling submission of the Biologics License Application (BLA) for abatacept submitted under the provisions of FDA’s Continuous Marketing Application, Pilot 1. Abatacept is an investigational biologic drug for the treatment of rheumatoid arthritis and its development program was granted Fast Track status by the FDA. Complete Non-Clinical and Clinical sections of the BLA have already been submitted to the FDA and the remaining sections will be submitted in early 2005.
Abatacept is Bristol-Myers Squibb’s first internally discovered biologic and, if approved, would be the first in a new class of agents called selective T-cell co-stimulation modulators.
Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.
This press release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans and projections regarding the Company’s product development and business strategy. These statements may be identified by the fact that they use words such as “will,” and other words and terms of similar meaning or expression. Such forward- looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. These factors include, among other things, competitive product development, difficulties and delays in product development, manufacturing and sales, patent positions and litigation. No forward-looking statement can be guaranteed. With respect to pipeline products, there can be no guarantee that the products will receive regulatory approval, or that they will prove to be commercially successful. Forward- looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb’s business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb’s Annual Report on Form 10-K/A for the year ended December 31, 2003 and in the Company’s Quarterly Reports on Form 10-Q. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
Bristol-Myers Squibb Company
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