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FDA Advisory Panel Recommends Abatacept

PRINCETON, NEW JERSEY (September 6, 2005) -- Bristol-Myers Squibb Company (NYSE:BMY) announced today that the U.S. Food and Drug Administration's (FDA) Arthritis Advisory Committee unanimously (7-0) recommended approval of Orencia® (abatacept), the company's investigational selective modulator of T-cell co-stimulation under development for the treatment of rheumatoid arthritis (RA). T-cell activation plays an important role in the immunopathogenesis of RA. The company presented pre-clinical and clinical data, and discussed the proposed pharmacovigilance program. The FDA is not bound by the Committee's recommendations.

Bristol-Myers Squibb completed its submission of a biologics license application (BLA) to the FDA for Orencia in March, and the original FDA action date was October 1, 2005. The FDA has informed Bristol-Myers Squibb that the Agency will require up to 90 additional days to complete the review of the abatacept BLA due to the complexity of the Chemistry and Manufacturing Controls (CMC) section of the application.

As previously stated, in order to meet expected long-term demand, Bristol-Myers Squibb expects to file a supplemental BLA (sBLA) for a second manufacturing facility at the earliest possible date following the BLA approval. The company is currently determining what, if any, impact the BLA delay could have on the timing of the sBLA approval and subsequent broad-scale commercial launch.

"Bristol-Myers Squibb is committed to the research and development of therapies that treat conditions in which unmet medical need exists, such as autoimmune disorders like rheumatoid arthritis," said Elliott Sigal, M.D., Ph.D., chief scientific officer and president, Pharmaceutical Research Institute, Bristol-Myers Squibb. "This commitment is evident through our Orencia clinical program in RA. We look forward to working with the FDA on bringing the product to patients in need."

Source: Bristol-Myers Squibb

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