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Sanofi and Regeneron Announce Collaboration with American College of Cardiology for PCSK9 Inhibitor Clinical Program
- Collaborationrepresents the first time the ACC's PINNACLE Registry Research Alliance will be used for clinical trial recruitment -
PARIS and TARRYTOWN, N.Y., Dec. 19, 2013 (GLOBE NEWSWIRE) -- Sanofi (EURONEXT : SAN and NYSE : SNY) and Regeneron Pharmaceuticals, Inc. (NASDAQ : REGN) announced today an innovative collaboration with the American College of Cardiology (ACC) focused on enhancing clinical research with alirocumab, an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9). PCSK9 is known to contribute to circulating low-density lipoprotein cholesterol (LDL-C) levels. Alirocumab is being co-developed by Sanofi and Regeneron.
Under the terms of the agreement, the ACC will apply its expertise in clinical research and utilize its extensive registries to identify patients who might be appropriate candidates for the Phase 3 ODYSSEY OUTCOMES clinical trial. This Data Driven Trial Recruitment Program is a new approach to identification and recruitment of patients for the clinical trial. Additional activities under the collaboration include a comprehensive educational program for both physicians and patients with the goal to broaden knowledge and understanding of the value of clinical trial research.
"This project represents another example of how medical registries can help transform medicine," said Ralph Brindis, past-President of the ACC and Senior Medical Officer of External Affairs for the National Cardiovascular Data Registries (NCDR). "The ACC's registries and related provider networks support quality improvement programs for practitioners. For the first time, through our PINNACLE ambulatory office-based registry of the NCDR, we will be helping to solve the difficult problem of identifying physicians with patients who may be eligible for a clinical trial."
"Through this collaboration, we hope to provide better access to our Phase 3 ODYSSEY OUTCOMES Trial," said Jay Edelberg, M.D., Ph.D. Vice President, PCSK9 Development and Launch Unit, Sanofi. This is the first time that ACC's PINNACLE Registry will be used for clinical trial recruitment, and we believe this novel approach will help trial sites meet and hopefully exceed their recruitment goals."