PRINCETON, N.J., April 25 Medarex, Inc.(Nasdaq: MEDX) and Bristol-Myers Squibb Company (NYSE: BMY) today announcedthat, after meeting with the U.S. Food and Drug Administration (FDA), thecompanies will delay the Biologics License Application (BLA) submission foripilimumab, an investigational immunotherapy for patients with advancedmetastatic melanoma. The FDA has requested additional overall survival (OS)data to further demonstrate the benefit of ipilimumab. Revised timelines areunder development, but a BLA for ipilimumab will not be submitted to the FDAin 2008.
The randomized Phase 3 trial evaluating the efficacy of ipilimumab incombination with dacarbazine versus dacarbazine alone in patients withuntreated unresectable Stage III or Stage IV melanoma is ongoing under SpecialProtocol Assessment (SPA). The companies are engaged in discussions with theFDA to change the primary endpoint in this trial from progression freesurvival (PFS) to OS. A potential submission for melanoma would includesurvival data from patients in the Phase 2 second-line studies and therandomized Phase 3 first-line trial currently ongoing.
Bristol-Myers Squibb and Medarex remain committed to the development ofipilimumab. The companies also have ongoing Phase 2 studies inhormone-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 atthe American Society of Clinical Oncology (ASCO) Annual Meeting this year.These include data from the three Phase 2 trials evaluating ipilimumab inpatients with advanced Stage III or Stage IV metastatic melanoma (Abstract#9010, 9021 and 9025).
Ipilimumab is being developed through a joint partnership betweenBristol-Myers Squibb and Medarex. Based on nonclinical and clinical studiesshowing that antibody blockade of CTLA-4 plays an important role in sustainingan active immune response to fight cancer, the companies are pursuing a broadclinical development program with ipilimumab. More than 2,000 patients havebeen treated in clinical trials with ipilimumab as a monotherapy or incombination with other agents.
For further information about ipilimumab clinical trials, please visitwww.clinicaltrials.gov.
Ipilimumab is a fully human antibody that binds to CTLA-4 (cytotoxic Tlymphocyte-associated antigen 4), a molecule on T-cells that plays a criticalrole in regulating natural immune responses. The absence or presence ofCTLA-4 can augment or suppress the immune system's T-cell response in fightingdisease. Ipilimumab is designed to block the activity of CTLA-4, therebysustaining an active immune response in its attack on cancer cells.
Medarex is a biopharmaceutical company focused on the discovery,development and potential commercialization of fully human antibody-basedtherapeutics to treat life-threatening and debilitating diseases, includingcancer, inflammation, autoimmune disorders and infectious diseases. Medarexapplies its UltiMAb(R) technology and product development and clinicalmanufacturing experience to generate, support and potentially commercialize abroad range of fully human antibody product candidates for itself and itspartners. More than 40 of these therapeutic product candidates derived fromMedarex technology are in human clinical testing or have had INDs submittedfor such trials, with seven of the most advanced product candidates currentlyin Phase 3 clinical trials or the subject of regulatory applications formarketing authorization. Medarex is committed to building value by developinga diverse pipeline of antibody products to address the world's unmethealthcare needs. For more information about Medarex, visit its Web site atwww.medarex.com.
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