Biotech Values

[DewDiligence]

SNY updates investors on anti-thrombosis pipeline.
See #msg-22938453 for the slides on AVE5026,
Idraparinux, SR123781, and Otamixaban. Also see
#msg-17021384 for background on these drug candidates

http://en.sanofi-aventis.com/Images/070917_rd_en_tcm24-18838.pdf

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Sanofi-aventis is today unveiling the highly promising results with AVE5026, a once-a-day ultra low molecular weight heparin. The results of the TREK dose-ranging study presented today demonstrate that AVE5026 reduces the risk of venous thrombo-embolic events compared to Lovenox with a good safety profile in patients requiring total knee replacement. In light of these very promising results, which position
AVE5026 as the potential successor to Lovenox, we have decided to implement a large-scale phase III program involving over 10,000 patients. The aim is to file for approval in 2010 in the prevention of venous thrombo-embolic events for patients requiring a hip or knee replacement, receiving chemotherapy, or undergoing abdominal surgery. Submission in the prevention of venous thrombo-embolic events in medical patients is scheduled for 2011.

Biotinylated idraparinux [a.k.a. SSR126517 ] is a selective, neutralizable factor Xa coagulation inhibitor. It is a long-acting pentasaccharide, with the addition of a biotin “hook” that allows, if needed, quick and effective neutralization by avidin. The clinical development program has been designed to bridge with clinical results obtained with idraparinux. A bioequipotency study in patients with deep vein thrombosis (EQUINOX) and another study in pulmonary embolism (CASSIOPEA) were initiated in 2006. Filing for approval in the treatment of deep vein thrombosis and pulmonary embolism is scheduled for 2009.

SR123781 is a short acting synthetic hexadecasaccharide , injected once daily, which is a powerful indirect inhibitor of Xa and IIa coagulation factors. The SHINE phase IIb study, evaluating SR123781 in patients with non-ST elevated acute coronary syndrome, demonstrated good safety with a bleeding rate similar to unfractionated heparins with or without abciximab [ReoPro] and with no induced thrombocytopenia. Phase III trials in acute coronary syndrome will begin in 2008, for a submission scheduled in 2012.

In addition, the DRIVE phase IIb study evaluating hexadecasaccharide in the prevention of venous thromboembolic
events in patients undergoing total hip replacement demonstrated excellent correlation between dose and clinical response, with very good safety.

Otamixaban is a selective, synthetic direct factor Xa inhibitor. It has a fast onset of action and a short half-life, and has a suitable profile for use in patients with acute coronary syndrome treated with invasive treatment. The SEPIA-PCI phase IIa study demonstrated a good safety profile with predictable and dose-related anticoagulant activity. Results from the SEPIA-ACS 1 phase IIb study are expected in the second half of 2008. Submission in this indication is scheduled for 2011.
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