ARNHEM and OSS, The Netherlands, Oct. 9, 2002 (PRIMEZONE) -- Akzo Nobel's (Nasdaq:AKZOY) human healthcare business, Organon, announces that it will take longer to complete the regulatory file for its new antidepressant drug, gepirone ER (previously known as Ariza), in the United States. It expects to submit the additional data required by the U.S. Food and Drug Administration (FDA) in the third quarter of 2003.
Originally it was envisaged to submit the data in the course of 2002. The delay is caused by the fact that it is taking longer than anticipated to enroll the required number of participants for the clinical study.
Pending the outcome of the study and FDA approval, Organon aims to launch gepirone ER in 2004.
Gepirone ER is a new drug for the treatment of patients with major depressive disorders.
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 over 67,000 people in 80 countries. Financial results for the third quarter will be published on October 23, 2002.
Organon is a renowned global pharmaceutical company with a strong commitment to human healthcare. 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 13,000 people. Organon is the ethical pharmaceutical business unit of Akzo Nobel.
Internet: www.akzonobel.com www.organon.com
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