Sanofi-Synthelabo to acquire Arixtra interests from Organon
Sanofi-Synthelabo, of Paris, France, has reached agreement with Organon to acquire all the latter's interests relating to Arixtra (fondaparinux sodium), idraparinux and other oligosaccharides such as the hexadecasaccharide.
Sanofi-Synthelabo, of Paris, France, has reached agreement with Organon to acquire all the latter's interests relating to Arixtra (fondaparinux sodium), idraparinux and other oligosaccharides such as the hexadecasaccharide.
In addition to taking over ongoing development programmes, Sanofi-Synthelabo will make payments to Organon based largely on future sales.
Sanofi-Synthelabo says this agreement is in line with its strategy to gain full control of the worldwide rights relating to innovative products in its r&d portfolio.
Arixtra, a selective synthetic factor Xa inhibitor, was launched in 2002 and 2003 in the US and in some other major markets. It is approved for the short-term and extended prophylaxis of venous thromboembolism in patients undergoing major orthopaedic surgery. In addition, it has now completed all planned studies in the prophylaxis and acute treatment of venous thromboembolism. Filing for the approval of the treatment indication was submitted to the FDA and the EMEA in July 2003.
Two additional submissions, namely, prophylaxis in medical and high-risk surgery situations, are expected to be filed for approval in the first half of 2004. Moreover, a very comprehensive phase III program for the treatment of patients with acute coronary syndrome is ongoing.
Idraparinux, a unique once-a-week synthetic pentasaccharide, is currently tested in phase III, against oral anticoagulant agents, in various indications including the prevention of vascular events associated with atrial fibrillation. This acquisition is expected to be completed in the first quarter of 2004, subject to the receipt of approvals from competition authorities.