Healthcare Industry News: ipilimumab
News Release - December 7, 2006
Medarex Announces FDA Fast Track Designations for Ipilimumab for the Treatment of Metastatic Melanoma; Fast Track Designations for First-Line Use in Combination With Chemotherapy and Second-Line Use as MonotherapyPRINCETON, N.J., Dec. 7 (HSMN NewsFeed) -- Medarex, Inc. (Nasdaq: MEDX ) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ipilimumab (also known as MDX- 010) used in combination with chemotherapy (dacarbazine) in previously untreated (first-line) metastatic melanoma patients. The FDA also has granted Fast Track designation for ipilimumab used as a monotherapy in previously treated (second-line) metastatic melanoma patients.
Under the FDA Modernization Act of 1997, designation as a Fast Track product for a new drug or biological product means that the FDA has determined that the drug or biologic is intended for the treatment of a serious or life- threatening condition and demonstrates the potential to address unmet medical needs for such a condition, and that the FDA will facilitate the clinical development and expedite the review of a Biologics License Application for the product. "We are pleased with the Fast Track designations as we continue to work with our partner Bristol-Myers Squibb to advance the development of ipilimumab, and we believe that ipilimumab has the potential to play an important role in the fight against cancer," said Irwin Lerner, Chairman of the Board of Directors and Interim President and CEO of Medarex.
ipilimumab is an investigational fully human antibody against human CTLA- 4, a molecule on T cells that is believed to be responsible for suppressing the immune response. Medarex and Bristol-Myers Squibb are investigating the potential of ipilimumab to enable the immune systems of cancer patients to help suppress or eradicate cancer tumors. ipilimumab is currently under investigation in several registrational clinical trials under Special Protocol Assessment agreements with the FDA for the treatment of metastatic melanoma -- as a first-line treatment in combination with dacarbazine, as a second-line monotherapy (enrollment expected to be completed this year) and as a second- line treatment in combination with MDX-1379 (a melanoma peptide vaccine). The combination with MDX-1379 was previously granted Fast Track designation. ipilimumab is also being evaluated in multiple Phase II clinical trials to investigate the product's potential activity in other tumor types, as well as in combination studies with chemotherapy, immunotherapy and vaccines. Further information regarding Medarex's and Bristol-Myers Squibb's ipilimumab program can be found in Medarex's public disclosure filings with the U.S. Securities and Exchange Commission (SEC).
Medarex is a biopharmaceutical company focused on the discovery, development and potential commercialization of fully human antibody-based therapeutics to treat life-threatening and debilitating diseases, including cancer, inflammation, autoimmune disorders and infectious diseases. Medarex applies its UltiMAb® technology and product development and clinical manufacturing experience to generate, support and potentially commercialize a broad range of fully human antibody product candidates for itself and its partners. Thirty-four of these therapeutic product candidates derived from Medarex technology are in human clinical testing or have had INDs submitted for such trials, with six of the most advanced product candidates currently in Phase III clinical trials. Medarex is committed to building value by developing a diverse pipeline of antibody products to address the world's unmet healthcare needs. For more information about Medarex, visit its website at www.medarex.com.
Medarex Statement on Cautionary Factors
Except for the historical information presented herein, matters discussed herein may constitute forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Statements that are not historical facts, including statements preceded by, followed by, or that include the words "potential;" "believe;" "anticipate;" "intend;" "plan;" "expect;" "estimate;" "could;" "may;" or similar statements are forward-looking statements. Medarex disclaims, however, any intent or obligation to update these forward-looking statements. Risks and uncertainties include risks associated with whether ipilimumab will help the immune systems of cancer patients to suppress or eradicate cancer tumors, product discovery and development, uncertainties related to the outcome of clinical trials, slower than expected rates of patient recruitment, unforeseen safety issues resulting from the administration of antibody products in patients, uncertainties related to product manufacturing as well as risks detailed from time to time in Medarex's public disclosure filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the fiscal year ended December 31, 2005 and subsequent Quarterly Reports on Form 10-Q. There can be no assurance that such development efforts will succeed or that other developed products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success. Copies of Medarex's public disclosure filings are available from its investor relations department.
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