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Sanofi-aventis Delivers 2008 Results Above Guidance
Date:2/11/2009

s review will continue until April 2009. As of now, the R&D portfolio comprises 65 projects in clinical development, of which 27 are in phase III or have been submitted to health authorities for approval. The main events are:

  • An application for approval of Ciltyri(R) (eplivanserin) in the treatment of sleep disorders was submitted to the FDA and the EMEA during the fourth quarter of 2008 and accepted for filing.
  • Subsequent to the submission of the application of Multaq(R) mid 2008 in the EU and U.S. which granted a priority review, a FDA advisory committee is scheduled for March 18.
  • Numerous molecules and vaccines have recently entered phase IIa, phase IIb or phase III:

Phase III:

  • the IMOJEV(TM) vaccine (Japanese encephalitis), for which the phase III study has started;
  • the micro-injection influenza vaccine, which has entered phase III in the United States.

Phase IIb:

  • the FAAH inhibitor SSR411298, in depression in the elderly;
  • the Dengue vaccine for moderate to severe fever
  • the ACAM-Cdiff (Clostridium difficile) vaccine, enters phase IIb after entering the portfolio in phase I via the acquisition of Acambis plc.

Phase IIa:

  • the NHE3 inhibitor (AVE0657) in sleep apnea;
  • the monoclonal antibody (AVE1642) in the treatment of breast cancer;
  • ataciguat, a guanylate cyclase activator, in neuropathic pain;
  • SAR97276 in the treatment of malaria;
  • a therapeutic vaccine against melanoma;
  • anti-rabies monoclonals (post-exposure prophylaxis).

    - The development of volinanserin (sleep disorders), satavaptan
      (dilutional hyponatremia and ci
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