Message 16772299
and
Monday December 10, 4:48 am Eastern Time
Press Release
SOURCE: Akzo Nobel
Akzo Nobel Announces Arixtra Approved by the FDA In the United States
ARNHEM / OSS, The Netherlands--(BUSINESS WIRE)--Dec. 10, 2001--Akzo Nobel's (EURONEXT: AKZ, NASDAQ: AKZOY), the international pharmaceuticals, coatings and chemicals group, business unit Organon and Sanofi-Synthelabo announced today that Arixtra® (fondaparinux sodium) has been approved in the United States by the Food and Drug Administration (FDA).
Arixtra® is indicated for the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism, in patients undergoing hip fracture surgery, hip replacement surgery, and knee replacement surgery.
The New Drug Application for Arixtra was submitted in the United States in February 2001, and was granted a six-month priority review. In August, Arixtra was granted an ``Approvable Letter'' by the FDA.
Arixtra is currently under review in the European Union, where the file was also submitted in February 2001.
Organon and Sanofi-Synthelabo expect to establish a strong position in the antithrombotic field with this new drug. Further clinical investigations are being carried out to extend Arixtra's use.
Arixtra is a synthetic compound and the first in a new class of antithrombotic agents that selectively inhibit Factor Xa. Arixtra was discovered and is being co-developed by Organon and Sanofi-Synthelabo.
The launch of Arixtra in the United States will occur in the first quarter of 2002.
Note for the editor
Akzo Nobel, based in the Netherlands, serves customers throughout the world with healthcare products, coatings and chemicals. Consolidated sales for 2000 totaled EUR14 billion (USD 13 billion, GBP 8.5 billion). The Company currently employs 67,400 people in 80 countries. Financial results for the full year 2001 will be published on February 22, 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. NV Organon is the ethical pharmaceutical business unit of Akzo Nobel.
Internet: akzonobel.com
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