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FDA approves labeling update for Orencia for rheumatoid arthritis

April 28, 2007

Bristol-Myers Squibb Company (NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA) has approved an update to the ORENCIA┬« (abatacept) product labeling regarding the progression of structural joint damage -- an important measure in the treatment of rheumatoid arthritis (RA). The indication was strengthened from “slowing” to “inhibiting” the progression of structural da mage in adult patients with moderately to severely active RA who have had an inadequate response to one or more disease-modifying, anti-rheumatic drugs (DMARDs), such as methotrexate (MTX) or tumor necrosis factor (TNF) antagonists.

ORENCIA is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural da mage, and improving physical function in adults with moderately to severely active RA who have had an inadequate response to one or more DMARDs, such as methotrexate or TNF antagonists. ORENCIA may be used as monotherapy or concomitantly with DMARDs other than TNF antagonists. ORENCIA should not be administered concomitantly with TNF antagonists and is not recommended for use concomitantly with anakinra.

ORENCIA, which was first approved on December 23, 2005, is a selective co-stimulation modulator of a signal required for full T-cell activation and works in a fundamentally different way than cytokine antagonists, including TNF antagonists.

The labeling change is supported by two-year radiographic data from the Phase III AIM (Abatacept in Inadequate responders to MTX) trial, which met the co-primary endpoints of ACR 20 scores at six months, Health Assessment Questionnaire Disability Index (HAQ-DI) scores at one year and joint Erosion Scores (ES) at one year. Fifty-six percent of ORENCIA® (abatacept)/MTX-treated patients had no progression during the first year compared to 45 percent of placebo/MTX-treated patients. In the open-label extension period of the study, 75 percent of patients initially randomized to ORENCIA and MTX and 65 percent of patients initially randomized to placebo and MTX were evaluated radiographically at Year 2. Progression of structural da mage in ORENCIA/MTX-treated patients was further reduced in the second year of treatment. Following two years of treatment with ORENCIA/MTX, 51 percent of patients had no progression of structural da mage as defined by a change in the Genant-Modified Total Sharp Score (TSS) of zero or less compared with baseline. More than half of patients on ORENCIA had no radiographic progression in either Year 1 or Year 2 (56 percent and 65 percent, respectively). (Last updated on Saturday, , and first posted on Friday, April 27, 2007)

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