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Sanofi-aventis Announces 2007 Earnings Ahead of Guidance Sharp Rise in Proposed Dividend
Date:2/12/2008

of the planned 17,000 have been enrolled to date.

Thrombosis

After consultation with the healthcare authorities, the large-scale phase III program for the ultra low molecular weight heparin AVE5026, involving over 10,000 patients, is being put into place. Positive results from phase IIb point to AVE5026 as a potential successor to Lovenox. AVE5026 is a powerful anti-coagulant with pharmaco-dynamic properties that go beyond anti-Xa factor activity. It is not associated with food interaction due to the subcutaneous mode of administration, giving total bioavailability. AVE5026 has the potential to offer better tolerance (reduced bleeding, no drug interaction, antiXa/IIa ratio of over 30). Filing for approval is scheduled for 2010 in the prevention of venous thromboembolic events in patients requiring hip or knee replacement, receiving chemotherapy or undergoing abdominal surgery.

Filing for approval in the prevention of venous thromboembolic events in medical patients is scheduled for 2011.

Idrabiotaparinux (biotinylated idraparinux) is a long-acting selective neutralizable factor Xa coagulation inhibitor, administered by weekly subcutaneous injection. Enrolment of patients to the EQUINOX bioequipotency study in deep vein thrombosis is now complete, and one-third of the patient population for the CASSIOPEA study in pulmonary embolism has been recruited to date. Filing for approval in the treatment of deep vein thrombosis and pulmonary embolism is scheduled for 2009.

Enrolment to the BOREALIS-AF comparative study, designed to assess the efficacy of biotinylated idraparinux versus anti vitamin K in the prevention of stroke and systemic embolism in patients with atrial fibrillation, has now begun. Filing for approval in this indication is scheduled for 2011.

Given the results from AVE5026, and as part of the portfolio rationalization process, sanofi-aventis has decided to discontinue the development of hexadecasaccharide.


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