Medarex and Bristol-Myers Squibb Joint Statement on Submission Status of ...( PRINCETON N.J. April 25 /- Medare...),Health

PRINCETON, N.J., April 25 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX) and Bristol-Myers Squibb Company (NYSE: BMY) today announced that, after meeting with the U.S. Food and Drug Administration (FDA), the companies will delay the Biologics License Application (BLA) submission for ipilimumab, an investigational immunotherapy for patients with advanced metastatic melanoma. The FDA has requested additional overall survival (OS) data to further demonstrate the benefit of ipilimumab. Revised timelines are under development, but a BLA for ipilimumab will not be submitted to the FDA in 2008.

The randomized Phase 3 trial evaluating the efficacy of ipilimumab in combination with dacarbazine versus dacarbazine alone in patients with untreated unresectable Stage III or Stage IV melanoma is ongoing under Special Protocol Assessment (SPA). The companies are engaged in discussions with the FDA to change the primary endpoint in this trial from progression free survival (PFS) to OS. A potential submission for melanoma would include survival data from patients in the Phase 2 second-line studies and the randomized Phase 3 first-line trial currently ongoing.

Bristol-Myers Squibb and Medarex remain committed to the development of ipilimumab. The companies also have ongoing Phase 2 studies in hormone-refractory prostate cancer and lung cancer as well as a Phase 3 study, to be initiated shortly, in adjuvant melanoma.

Twelve abstracts evaluating ipilimumab in melanoma will be presented at the American Society
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