Oral cancer drug discovered and developed by Novartis is approved in first indication for Chronic Myeloid Leukemia

Basel, Switzerland, 10 May 2001 – Novartis today announced that the United States Food and Drug Administration (FDA) approved its drug Glivec® - In the US: Gleevec™ (imatinib mesylate); outside the US: Glivec® (imatinib) - as an oral therapy for the treatment of patients with chronic myeloid leukemia (CML) in the blast crisis, accelerated phase or in chronic phase after failure of interferon-alpha therapy.

According to Dr. Daniel Vasella, Chairman and CEO of Novartis, "We are gratified that our researchers, based on an unconventional approach and profound understanding of cancer biology, have discovered a breakthrough cancer therapy. Glivec dramatically improves the lives of many patients suffering from CML, and has the promise to work in additional cancers. Based on the dedicated efforts of my Novartis colleagues and a constructive collaboration with FDA, we have succeeded in bringing this revolutionary drug to the patients in record time."

Glivec is the first oncology drug to be developed with rational drug design, achieving striking results based on an understanding of how cancer cells work. The drug addresses the genetic malfunction present in CML patients. This particular type of leukemia is caused by a so-called reciprocal translocation between chromosome 9 and 22, resulting in the "Philadelphia chromosome," a well-known marker for CML. As a result, a new and abnormal protein called Bcr-Abl causes the uncontrolled proliferation of white blood cells, resulting in leukemia. Glivec has been designed to specifically block the function of this protein. The preciseness by which the drug targets the cancer cell differentiates Glivec from most other oncology products. This results in unsurpassed efficacy and fewer side effects. In clinical trials, 88 percent of patients have had their white blood cell counts return to normal and 49 percent have had either a disappearance or significant reduction of the Philadelphia chromosome.

Upon the first hint of the dramatic potential of this new agent, Novartis rapidly invested extraordinary manpower to scale-up manufacturing and to expedite the clinical development, allowing many more patients to enter clinical studies and have access to the drug. As a result, the New Drug Application was filed only 32 months after the first dose in man, more than halving the typical drug development timeframe of approximately six years.

The highly positive clinical results prompted FDA to grant a priority review. This resulted in an approval after only a two and one half month review time, making this the fastest time to market of any cancer treatment.

Patients' access to Glivec has been a key concern of Novartis and ultimately more than 7,500 patients are currently under treatment. Of these patients, approximately 5,000 are part of an expanded access program, which was established solely to provide access to patients who were in medical need. The data from these 5,000 patients were not needed to seek marketing authorization for the drug.

Novartis has put in place a comprehensive patient assistance program, which insures that uninsured, indigent patients are not denied therapy for economic reasons. In the U.S., the program will be administered by Documedics who will evaluate patient need. A patient assistance hotline has been put in place and can be reached at 1 877 453 3832. Outside the U.S., patients should contact the Medical Department of the local Novartis Pharma Company.

Clinical Data
The FDA approval was based on data from three large Phase II studies that showed a cytogenetic response (the disappearance or reduction of Philadelphia-chromosome positive cells) in patients with advanced stages of CML (21 percent in the accelerated phase and 14 percent in myeloid blast crisis, respectively). Patients with chronic phase CML after failure with interferon therapy achieved an 88 percent haematologic response and 49 percent overall major cytogenetic response, both primary endpoints of the studies. To date, Glivec has been studied in more than 7,500 patients at 490 sites in 30 countries.

Glivec also inhibits two other proteins, the c-kit receptor, active in cancers including gastrointestinal stromal tumours (GIST), and small cell lung cancers, and the PDG-F receptor, active in gliomas, prostate, and soft tissue sarcomas. Trials in GIST, and in glioblastoma, a kind of brain tumour, are currently underway. The first data in solid tumours, the GIST data, will be discussed during the 37th annual meeting of the American Society of Clinical Oncology (ASCO) in San Francisco, California, 11-15 May 2001.

Novartis has submitted filing applications for Glivec to health authorities in the European Union, Switzerland, Canada, Australia and Japan. Glivec has been designated as an Orphan Drug in the United States, European Union, and in Japan.

Important Risk Information
The majority of Glivec-treated patients experienced adverse events at some time. Most events were mild to moderate grade, but drug was discontinued for adverse events in 1% of patients in chronic phase, 2% in accelerated phase and 5% in blast crisis. In clinical trials in the three phases of CML studied, adverse events, regardless of relationship to study drug, include nausea (55-68%), fluid retention (52-68%, muscle cramps (25-46%), diarrhoea (33-49%), vomiting (28-54%), haemorrhage (13-48%), musculoskeletal pain (27-39%), skin rash (32-39%), headache (24-28%) and fatigue (24-33%). Oedema was most frequently periorbital or in lower limbs and was managed with diuretics, other supportive measures, or by reducing the dose of Glivec. The frequency of severe edema was 1-5%. More serious side effects include elevated liver enzymes (1.1-3.5%), severe superficial oedema (1-5%) and haemorrhages (0.4-16%).

Women of childbearing potential should be advised to avoid becoming pregnant while taking Glivec. Treatment with Glivec is often associated with neutropenia and/or thrombocytopenia. Glivec is contraindicated in patients hypersensitive to imatinib or to any other component of Glivec.

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 "will," "believe," "effective," "ground breaking," "intended," "significantly advance, " or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of a new product, Glivec, for which the company has filed global marketing applications, and anticipated customer demand for such products. Such 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 Glivec to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Some of these are uncertainties relating to unexpected regulatory delays, future clinical trial results, government regulation or competition in general, as well as factors discussed in the company's Form 20F filed with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.

Novartis (NYSE: NVS) is a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 2000, the Group's ongoing businesses achieved sales of CHF 29.1 billion (USD 17.2 billion) and a net income of CHF 6.5 billion (USD 3.9 billion). The Group invested approximately CHF 4.0 billion (USD 2.4 billion) in R&D. Headquartered in Basel, Switzerland, Novartis employs about 69 000 people and operates in over 140 countries around the world. For further information please consult http://www.novartis.com.