Updated on 15 January 2013
Sanofi provides update about its product portfolio, key development milestones and regulatory milestones
Singapore: Sanofi provide an update on its R&D pipeline with Dr Elias Zerhouni, president, global R&D, presenting at the 31st Annual J P Morgan Healthcare Conference in San Francisco, US, held from January 7-9, 2013.
Executing a successful strategy to reposition Sanofi R&D has fueled a pipeline with 65 New Molecular Entity (NME) projects and vaccine candidates in clinical development of which 17 are in phase III or have been submitted to the health authorities for approval.
"Sanofi has made significant progress in the transformation of its R&D over the last couple of years, including advances in late stage projects and early stage pipeline as well as talent recruitment. We feel we have the ingredients to ensure R&D contributes to Sanofi's goal of sustainable growth in the coming years while rigorously managing R&D costs," said Dr Zerhouni.
Regarding regulatory milestones, Sanofi received two positive opinions from the Committee for Medicinal Products for Human Use (CHMP) since the last R&D update on October 25, 2012, with decisions from the European Commission targeted in Q1 2013: Lyxumia (lixisenatide) in type 2 diabetes and Zaltrap (aflibercept) in metastatic second-line colorectal cancer.
Portfolio update: SAR236553 (developed in collaboration with Regeneron), a subcutaneously administered, fully-human antibody, is being evaluated for its impact on lowering low-density lipoprotein cholesterol (LDL-C) by targeting PCSK9. In November, Sanofi and Regeneron announced that the Odyssey and Outcomes trial, a phase III cardiovascular outcomes trial with SAR236553 started to recruit patients. This study will enroll approximately 18,000 patients, who recently suffered an acute coronary syndrome. With the start of this study, eleven phase III trials are now recruiting hypercholesterolemic patients not at goal for LDL-C and mainly at high cardiovascular risk, a population estimated at 21 million people globally.