ARNHEM/OSS, The Netherlands, March 27, 2002 (PRIMEZONE) -- Akzo Nobel's (Nasdaq:AKZOY) business unit, Organon and Sanofi-Synthelabo, today announced that Arixtra(r) (fondaparinux sodium) has received marketing approval from the European Commission, for the following indication:
"Prevention of Venous Thromboembolic Events (VTE) in patients undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee or hip replacement surgery."
The recommended dose regimen of Arixtra(r) is 2.5 mg once daily administered post-operatively by subcutaneous injection. In a pooled analysis of the clinical studies, the recommended dose regimen of Arixtra(r) versus enoxaparin was associated with a significant decrease (54%) in the rate of VTE, irrespective of the type of surgery performed.
The first launches of Arixtra(r) in the European Union will occur in the second quarter of 2002, starting with Germany, the United Kingdom, the Netherlands. In the United States, Arixtra(r) was launched in February 2002.
Arixtra(r) was filed in the European Union in February 2001 and the Committee for Proprietary Medicinal Products (CPMP) adopted a positive opinion in December 2001.
Sanofi-Synthelabo and Organon expect to establish a strong position in the antithrombotic field with Arixtra(r). Further clinical investigations are being carried out to extend the use of Arixtra(r) for VTE prevention in medical and surgical high risk situations, for the treatment of venous thrombosis and pulmonary embolism and for the treatment of patients with acute coronary syndrome.
Arixtra(r) is a synthetic compound and the first in a new class of antithrombotic agents that selectively inhibit factor Xa. It was discovered and is being co-developed by Sanofi-Synthelabo and Organon.
Note for the Editor
Akzo Nobel, based in the Netherlands, serves customers throughout the world with healthcare products, coatings and chemicals. Consolidated sales for 2001 totaled EUR 14 billion. The Company currently employs approximately 66,000 people in 80 countries. Financial results for the first quarter will be published on April 23, 2002.
Organon is a renowned global pharmaceutical company with a strong commitment to health care. The company develops and produces innovative prescription medicines for gynecology, psychiatry, cardiovascular disease, immunology and anesthesiology. Organon products are sold in over 100 countries, more than half of which have an Organon subsidiary. The company currently employs around 12,500 people. Organon is the ethical pharmaceutical business unit of Akzo Nobel.
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