"Prevention and treatment of thrombo-embolism is a major public health issue," said Professor Job Harenberg, MD, Professor of Medicine at the Faculty of Clinical Medicine Mannheim, University of Heidelberg. "There are significant challenges to demonstrating therapeutic equivalence of a complex biological product such as enoxaparin without direct comparative clinical trials to assess efficacy, and even more importantly safety as published in the Consensus recommendation on biosimilars LMWHs(1). Physicians and patients need to remain fully confident that when they use enoxaparin they will have consistent access to the highest quality products to treat such life-threatening conditions."
As a worldwide leader in the field of low-molecular weight heparins, sanofi-aventis has been regularly communicating with the FDA since the 1980's on the quality standards of enoxaparin sodium and most recently through a Citizen's Petition to share the company knowledge on heparins. However, the FDA-approved version has not been assessed on the basis of an extensive clinical program showing proven and comparable clinical efficacy and safety to Lovenox®. Lovenox® is the most widely studied LMWH in the world, with more than 16 years of clinical and real-world experience in the U.S.
Sanofi-aventis will avail itself of appropriate analytical and clinical avenues to assess the quality, efficacy and safety of the product and is considering all appropriate legal options.
Sanofi-aventis is committed to making healthcare professionals aware of the complexities related to the biologic composition and manufacturing of Low Molecular Weight Heparins and Lovenox®, so that they can make informed decisions about the best treatment option for their patients.
Lovenox® is a global product. Introduction of another version of enoxaparin sodium in the US would compete with less than 60% of overall Lovenox®/Clexane® sales. Lovenox® sales outside of the US have been growing faster than in the US and represent more than 40% of Lovenox total sales in 2009. Regulations for biosimilars requiring comparative studies for low molecular weight heparins exist in Europe and Australia.
As a preliminary guidance, the Group expects business EPS for the year 2010 to be stable to down 4% versus 2009, at constant exchange rates. The group reiterates its 2013 objectives as announced in July 2009.
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
1. Recommendations on biosimilar low-molecular weight heparins, J.Harenberg et al. on behalf of the Subcommittee on control of Anticoagulation of the SSC of the ISTH, Journal of Thrombosis and Haemostasis,2009; 7: 1222-1225.