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Sanofi and Regeneron Announce Patient Enrollment in Two Phase 3 Trials with Sarilumab in Rheumatoid Arthritis (RA)
Date:5/14/2013

PARIS and TARRYTOWN, N.Y., May 15, 2013 /PRNewswire/ -- Sanofi (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the COMPARE and ASCERTAIN trials of sarilumab, the first fully human monoclonal antibody directed against the IL-6 receptor, which is delivered by subcutaneous injection every other week, have enrolled their first patients.

The broad SARIL-RA clinical development program is focused on adult populations with moderate-to-severe rheumatoid arthritis (RA) who are inadequate responders to either methotrexate (MTX) or tumor necrosis factor alpha (TNF-alpha) inhibitor therapy.  The SARIL-RA program is comprised of the following five trials: SARIL-RA MOBILITY, SARIL-RA TARGET, SARIL-RA COMPARE, SARIL-RA ASCERTAIN, and an open-label extension trial, SARIL-RA EXTEND.  The program is targeted to enroll approximately 2,600 patients with moderate-to-severe rheumatoid arthritis.  The primary objective of the overall Phase 3 program is to determine the safety and efficacy of sarilumab in reducing the signs and symptoms of RA, as well as inhibiting disease progression, in a broad range of patients.  Two doses of sarilumab are being studied in the SARIL-RA program: 150 milligrams (mg) every other week and 200mg every other week. 

The SARIL-RA ASCERTAIN trial is a multi-center, randomized, double-blind, active-calibrator, Phase 3 trial of 24 weeks that will assess the safety and tolerability of sarilumab and tocilizumab, both in combination with MTX, in patients with RA who are inadequate responders to, or intolerant of, TNF-alpha inhibitors.  The primary endpoint of this study is safety.

"Despite the advances that TNF-alpha inhibitors have made in the management of patients with RA, up to 40 percent of patients are inadequately c
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SOURCE Regeneron Pharmaceuticals, Inc.
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