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Top-Line Data Available from Three Ipilimumab Pivotal Trials in Patients with Advanced Metastatic Melanoma
Date:12/10/2007

Conference call scheduled for tomorrow, Tuesday, December 11, 2007 at 8:45

am ET

PRINCETON, N.J., Dec. 10 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX) and Bristol-Myers Squibb Company (NYSE: BMY) today announced top-line data from the three registrational trials (008, 022, 007) that constitute the monotherapy program for ipilimumab -- an investigational immunotherapy -- in patients with metastatic melanoma. The results from study 008, conducted under Special Protocol Assessment (SPA), did not meet the primary endpoint, which was to rule out a best objective response rate of less than 10 percent. However, the totality of data from the registrational program included a clear dose response effect observed in study 022 and best objective response rates across the three studies ranging from mid-single digits to mid-teens as determined by independent radiology review.

The objective responses were consistent with previous observations and included complete and partial responses. The majority of the responses were ongoing at the end of the observation period. In contrast to standard cytotoxic therapy, responses at the highest doses were noted to evolve over time; these patterns of response appear potentially unique to this form of therapy.

Given the importance of these findings and the limited treatment options for this patient population, Medarex and Bristol-Myers Squibb are planning to meet with regulatory agencies in the near future. Pending these discussions,
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SOURCE Bristol-Myers Squibb Company; Medarex, Inc.
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