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Resilient Sales and Business EPS(1) in Q3 2010
Date:10/28/2010

nd half of 2011.
  • The final results from a randomized Phase II clinical trial were presented in October at the European Society for Medical Oncology, confirming that treatment with iniparib (BSI-201) in combination with gemcitabine/carboplatin results in a significant improvement in overall survival and a high rate of clinical response in women with metastatic triple negative breast cancer (mTNBC). Iniparib which is currently in Phase III in mTNBC, was granted Fast Track designation which allows a rolling submission to the FDA. The regulatory submissions will include final Phase III results and are planned for Q1 2011 in the U.S. and Q2 2011 in the European Union for this indication.
  • The results from the two-year phase III TEMSO study of teriflunomide, a novel oral disease modifier investigated for the treatment of relapsing multiple sclerosis (RMS), were presented in October during the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) congress. In this study, both doses of teriflunomide (7mg and 14mg) significantly reduced annualized relapse rate (primary study endpoint) by 31% vs. placebo (p<=0.0005). The risk of disability progression (sustained for 12 weeks) was also significantly reduced by 30% for the 14mg dose (p=0.02) and numerically reduced by 24% for the 7mg dose (p=0.08). Both doses of teriflunomide were well tolerated. In addition to the TEMSO trial, two other Phase III trials, TOWER (versus placebo) and TENERE (versus IFN Beta 1-a), are ongoing in RMS patients. A Phase III study, TOPIC, is also underway in early multiple sclerosis or CIS (clinically isolated syndrome). A Phase III study, TERACLES, evaluating teriflunomide as an adjunct therapy to IFN Beta is planned to start before the end of 2010.

    • During the third quarter, sanofi pasteur took the decision to discontinue its Adacel® (DTaP) fifth dose vaccine candidate in phase III, and replace it with Quadracel
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