This news release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron, and actual events or results may differ materially from these forward-looking statements. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of Regeneron's product candidates and research and clinical programs now underway or planned, including without limitation SAR236553/REGN727, unforeseen safety issues resulting from the administration of products and product candidates in patients, the likelihood and timing of possible regulatory approval and commercial launch of Regeneron's late-stage product candidates, determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's product and drug candidates, competing drugs that may be superior to Regeneron's product and drug candidates, uncertainty of market acceptance of Regeneron's product and drug candidates, unanticipated expenses, the availability and cost of capital, the costs of developing, producing, and selling products, the potential for any license or collaboration agreement, including Regeneron's agreements with the Sanofi Group and Bayer HealthCare, to be canceled or terminated without any product success, and risks associated with third party intellectual property and pending or future litigation relating thereto. A more complete description of these and other material risks can be found in Regeneron's filings with the United States Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2011 and Form 10-Q for the quarter ended March 31, 2012. Regeneron does not undertake any obligation to update publicly any forward-looking statement, whether as a result of new information, future events, or otherwise, unless required by law.
- Stein EA, et al. Effect of a monoclonal antibody to PCSK9, REGN727/ SAR236553, to reduce low-density lipoprotein cholesterol in patients with heterozygous familial hypercholesterolaemia on stable statin dose with or without ezetimibe therapy: a phase 2 randomised controlled trial. Lancet 2012 May 26. [Epub ahead of print].
- Stein EA, et al. A randomized, double-blind, placebo-controlled trial of the safety and efficacy of a monoclonal antibody to PCSK9, REGN727/ SAR236553, in heterozygous familial hypercholesterolemia patients on a stable statin dose with or without ezetimibe therapy. (NCT:01266876). Presented at the 80 th EAS Congress, Milan, Italy; May 26, 2012. Abstract #1398.
- Sanofi and Regeneron Report Positive Preliminary Phase 2 Program Results for Anti-PCSK9 Antibody in Hypercholesterolemia. Press release available at: http://investor.regeneron.com/releasedetail.cfm?ReleaseID=622543. Last accessed 20 May 2012.
- Steinberg D & Witztum JL. Inhibition of PCSK9: A powerful weapon for achieving ideal LDL cholesterol levels. PNAS 2009;106:9546-7.
- Konrad RJ, et al. Effects of currently prescribed LDL-C-lowering drugs on PCSK9 and implications for the next generation of LDL-C-lowering agents. Lipids Health Dis 2011;10:38.
- Citkowitz E. Familial Hypercholesterolemia. Available at: http://emedicine.medscape.com/article/121298-overview#showall. Last accessed 30 April 2012.
- Pijlman, AH et al. Evaluation of cholesterol lowering treatment of patients with familial hypercholesterolemia: a large cross-sectional study in The Netherlands. Atherosclerosis 2010;209:189-94.
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SOURCE Sanofi and Regeneron Pharmaceuticals, Inc