To print: Select File and then Print from your browser's menu

Title: FDA Approves Clozaril (Clozapine) To Reduce The Risk Of Suicidal Behavior

"FDA Approves Clozaril (Clozapine) To Reduce The Risk Of Suicidal Behavior"

EAST HANOVER, NJ -- December 19, 2002 -- Novartis Pharmaceuticals Corporation announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market Clozaril® (clozapine) for the treatment of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are at chronic risk. This action by the FDA marks the first time that any medication has been approved for use in treatment of suicidal behavior. Although generic versions of Clozaril are available, FDA regulations provide Novartis with exclusive rights to market the new indication for a period of 36 months. Novartis filed a supplemental New Drug Application (sNDA) in March 2002, for the indication based upon data from the International Suicide Prevention Trial (InterSePT(TM)), the first study ever to prospectively evaluate a medication in reducing the risk of suicidal behavior. Suicide is the leading cause of premature death among patients with schizophrenia and schizoaffective disorder. Overall, these patients have approximately a 40% lifetime risk for suicide attempts and a 10% risk for a completed suicide. Suicidal behavior embodies symptoms ranging from suicidal thoughts, to suicidal plans and actual suicide attempts. InterSePT™ was a prospective, multi-center, randomized study initiated in 1998 to compare the efficacy of two antipsychotic compounds, Clozaril and Zyprexa® (olanzapine)* one of the world's most widely prescribed antipsychotic medications, in reducing the risk of suicidal behavior among patients with schizophrenia or schizoaffective disorder. Clozaril reduced the risk of suicide attempts and hospitalizations to prevent suicide by about 25% compared to Zyprexa. These results were not related to the use of greater concomitant psychotropic medication as Clozaril-treated patients required fewer concomitant psychotropic medications such as antidepressants, anxiolytics, anti-psychotics and mood stabilizers. The safety profile observed in the study was consistent with the well-known characteristics of Clozaril. Clozaril is still also indicated for the treatment of severely ill schizophrenic patients who fail to respond adequately to standard antipsychotic drug therapies. For complete prescribing information, please call Harry Rohme at 973 781-5151 or, refer to the Clozaril package insert at: http://www.pharma.us.novartis.com/product/pi/pdf/clozaril.pdf . Clozaril use is associated with a substantial risk of seizure affecting 1% to 2% of patients at low doses (below 300 mg/day), 3% to 4% at moderate doses (300 mg/day to 600 mg/day), and 5% at high doses (600 mg/day to 900 mg/day). In clinical trials, Clozaril was associated with a 1% to 2% incidence of agranulocytosis, a potentially fatal blood disorder, which, if caught early, can be reversed. Mandatory weekly white blood cell counts and weekly drug dispensing provide an efficient means of determining developing agranulocytosis. Analysis of post-marketing safety databases suggest that Clozaril is associated with an increased risk of fatal myocarditis, especially during, but not limited to, the first month of therapy. Orthostatic hypotension may occur in some patients, especially during the initial phases of treatment, and can, in rare cases (approximate incidence of 1/3,000), be accompanied by collapse and/or cardiac arrest. This release contains certain implied "forward-looking statements," relating to the Company's business. Such statements include descriptions of the potential benefit of Clozaril as evidenced by clinical trial results. Those statements reflect the current views of the Company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the Company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. There are no guarantees that the aforementioned approval will result in the commercialization of Clozaril to reduce suicidal behavior in any market. Any such commercialization can be affected by, among other things, uncertainties relating to regulatory actions, delays in or government regulation generally, competition in general and other risks and factors referred to in the Company's current Form 20-F on file with the Securities and Exchange Commission of the United States. Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including central nervous system disorders, organ transplantation, cardiovascular diseases, dermatological diseases, respiratory disorders, cancer and arthritis. The company's mission is to improve people's lives by pioneering novel healthcare solutions. Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG (NYSE: NVS), a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 2001, the Group's businesses achieved sales of CHF 32.0 billion (USD 19.1 billion) and a net income of CHF 7.0 billion (USD 4.2 billion). The Group invested approximately CHF 4.2 billion (USD 2.5 billion) in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 74,000 people and operate in over 140 countries around the world. * Zyprexa® is a trademark of Eli Lilly and Company SOURCE: Novartis Pharmaceuticals Corporation

Copyright © 2009 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content.