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FDA Committee Recommends Approval for Clozaril to Treat Suicidal Behavior -- Drug Could Be First Ever With Indication --

EAST HANOVER, NJ -- November 5, 2002 -- Novartis Pharmaceuticals Corporation announced that the US Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee voted to recommend that the FDA approve the use of Clozaril® (clozapine) for the treatment of emergent suicidal behavior in patients with schizophrenia or schizoaffective disorder. FDA reviewers will consider the panel's suggestion before making a final decision. If the new indication is granted, it will mark the first time that any medication has been approved for use in treating suicidal behavior.

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.

Dr. Daniel Vasella, Chairman and Chief Executive Officer of Novartis AG commented, "Current estimates suggest that at least two million Americans suffer from schizophrenia, about ten percent of whom will actually die as a result of suicide. The data from our InterSePT(TM) study demonstrated that Clozaril reduced the risk of suicide attempts and hospitalizations to prevent suicide among individuals suffering from schizophrenia or schizoaffective disorder by 26% compared to Zyprexa®*(olanzapine). I am most gratified that our drug Clozaril, has the potential to provide a life saving benefit to those schizophrenia patients who are most in need."

Suicidal behavior embodies symptoms ranging from suicidal thoughts, to suicidal plans and actual suicide attempts. InterSePT(TM) was a multi-center, randomized study initiated in 1998 to compare the efficacy of two antipsychotic compounds, Clozaril and Zyprexa* one of the world's most widely prescribed antipsychotic medications, in reducing the risk of suicidal behavior among patients with schizophrenia or schizoaffective disorder. In addition to reduced suicide attempts and hospitalizations to prevent suicide, patients treated with Clozaril also required fewer concomitant psychotropic medications. The safety profile observed in the study was consistent with the well-known characteristics of Clozaril.

"Today's FDA Advisory Committee recommendation is an important milestone because the risk of suicide and suicidal behavior in schizophrenia is enormous," said Dr. John M. Kane, Vice President for Behavioral Health Services at the North Shore Long Island Jewish Health System, and a lead investigator in the study. "Approximately half of all patients with schizophrenia will attempt suicide during their lifetime. The consequences of that are staggering. When the data suggested that Clozaril might offer hope to these most vulnerable of patients, it was heartening that Novartis moved quickly to conduct this study despite the fact that many other companies would have considered Clozaril a mature product."

According to the National Institute of Mental Health (NIMH), 29,199 Americans committed suicide during 1999. While no reliable data exists on the number of attempted suicides each year, researchers believe that there are between 8 and 25 attempts for each completed suicide. A study by Palmer et al, published in Clinical Neuropharmacology in 1995 estimated that each suicide attempt results in at least $33,000 in direct and indirect costs.

"Overall, this study demonstrated that Clozaril is superior to Zyprexa®* for the prevention of suicide attempts in patients with schizophrenia and schizoaffective disorder who are at high risk for suicide," Dr. Kane said. "Wider use of Clozaril in this population could very well help to save many lives each year. I think that InterSePT™ will fundamentally change the care that suicidal patients with psychosis receive in the future."

James McNulty, president of the Board of Directors of the National Alliance for the Mentally Ill (NAMI), welcomed the news about the panel vote, "The human toll of suicide in schizophrenia is unacceptable," he notes. "Very often the caregivers for people with schizophrenia are parents or other family members who expend tremendous emotional and financial resources on their care. To lose a beloved family member to suicide creates a void in the fabric of family life that can never be repaired."

Since being introduced in the United States in 1990, Clozaril has established a unique role in the treatment of patients with refractory schizophrenia, and serves as a standard of comparison for the efficacy of most other antipsychotic medications. The compound is classified as an atypical antipsychotic because its profile of binding to certain dopamine receptors and its effects on various dopamine mediated behaviors, differs from those exhibited by older or "typical" antipsychotic drugs. In particular, Clozaril is recognized for a unique binding profile which is associated with a particularly low propensity for movement disorders (extrapyramidal side effects) seen with the typical antipsychotic medications.

Clozaril is currently 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 suggests 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 "forward-looking statements," relating to the Company's business, which can be identified by the use of forward-looking terminology such as "if," "would," "will," or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the potential benefit of Clozaril as evidenced by initial 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 clinical trial 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.

For further information about Novartis Pharmaceuticals Corporation please consult http://www.pharma.us.novartis.com. For further information about Novartis AG, please consult http://www.novartis.com.

* Zyprexa is a trademark of Eli Lilly and Company


SOURCE: Novartis Pharmaceuticals Corporation

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