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Biotech / Medical : IVAX Insider Trading -- Ignore unavailable to you. Want to Upgrade?

To: 5,17,37,5,101,... who wrote (226)	12/2/1997 11:22:00 AM
From: flickerful	Read Replies (1) \| Respond to of 756

Unique Clozaril National Registry Paramount to Patient Safety BASEL, Switzerland, Dec. 1 /PRNewswire/ -- In light of the FDA's decision to approve a generic version of Clozaril(R) by IVAX Corporation, Novartis Pharmaceuticals Corporation, manufacturer of Clozaril tablets, reemphasized today its commitment to the safe and effective treatment of therapy-resistant schizophrenia. ''Clozaril is a uniquely effective treatment for severely ill patients with schizophrenia who have failed to respond to other antipsychotic therapies,'' said Wayne Yetter, CEO of Novartis Pharmaceuticals Corporation. ''In addition, it is the only antipsychotic that is not associated with a significantly increased risk of parkinsonian symptoms or tardive dyskinesia.'' In clinical trials conducted prior to approval of Clozaril in the U.S., the use of Clozaril was associated with a 1-2% incidence of agranulocytosis, a potentially fatal decrease in the white blood cell count. In an effort to manage this side effect, discussions with the FDA were held that led to the introduction of Clozaril in conjunction with a comprehensive patient monitoring system. This program, the Clozaril National Registry(R)(CNR), is a unique patient monitoring system which mandates weekly blood sampling from patients receiving treatment based upon a ''no blood, no drug'' policy. The use of the CNR system in over 165,000 U.S. patients over the past seven years has resulted in a documented reduction of agranulocytosis from the initially reported incidence of 1-2% to a current rate of 0.38%. Largely due to the success of this patient monitoring system, the FDA Advisory Committee met in July 1997 and unanimously recommended a reduction in the frequency of monitoring to bi-weekly after six months. Yetter further commented, ''Novartis attributes a reduction in agranulocytosis and improved safety for patients to the unique features of the CNR.'' In addition to monitoring patients who receive Clozaril, the registry fulfills another vital function, it identifies patients who are at an unacceptably high risk for developing agranulocytosis and, therefore, should never be re-exposed to treatment with Clozaril. Novartis would like to assure consumers of Clozaril that it will continue to insure the high quality of the monitoring provided by the CNR. Novartis will cooperate with the FDA and other manufacturers who are equally committed to meeting the high standards of the CNR to insure patient safety. Novartis is a world leader in Life Sciences, with its core businesses in Healthcare, Agribusiness and Nutrition. In 1996, Novartis achieved group sales of 27.6 billion Swiss francs, of which 16.3 billion were in Healthcare, 7.6 billion in Agribusiness and 3.7 billion in Nutrition, and invested more than 3 billion Swiss francs in research and development. Headquartered in Basel, Switzerland, Novartis employs 88,000 people in more than 100 countries around the world. SOURCE: Novartis Pharmaceuticals Corporation ------------------------------------------------------------------------ More Quotes and News:Novartis AG (OTC BB:NVTSY - news)Related News Categories: health care ------------------------------------------------------------------------ Help ------------------------------------------------------------------------ Copyright c 1997 PRNewswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Important Disclaimers and Legal Information Questions or Comments?