Prostate cancer bone mets

Novartis announced today that the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) recommended approval of ZOMETA(R) (zoledronic acid for injection) for the treatment of bone complications (metastases) associated with a broad range of tumor types. These include prostate cancer, lung cancer, and other tumor types for which no intravenous bisphosphonate therapy is currently approved for treatment, as well as breast cancer and the osteolytic lesions associated with multiple myeloma. ZOMETA offers patients and clinicians a highly effective treatment with a convenient 15-minute infusion time.

"Novartis is pleased that ODAC has recognized the favorable results of ZOMETA in the treatment of bone metastases in a broad range of tumor types and has recommended its approval," said David Parkinson, MD, Vice President, Clinical Research at Novartis Oncology. "Based on extensive experience, we believe that ZOMETA offers significant benefit for helping cancer patients manage this painful and debilitating aspect of their disease."

The FDA generally follows the recommendations of its Advisory Committees although it is not obliged to do so. Novartis submitted the new drug application (NDA) for the use of ZOMETA in these indications to the U.S. FDA on August 22, 2001 and, on October 23, 2001 the NDA received a priority review designation. Submission to the EMEA in the European Union was made on July 30, 2001.

Clinical Data

The NDA for ZOMETA is based on data from three large international clinical trials evaluating more than 3,000 patients with myeloma, breast cancer, prostate cancer, lung cancer and other solid tumors. This is the largest set of clinical trials ever conducted to evaluate the efficacy and tolerability of a bisphosphonate in treating cancerous bone lesions.

In the prostate cancer trial, ZOMETA demonstrated efficacy when compared to placebo in the treatment of bone metastases. Over the 15-month evaluation period of this trial, a lower proportion of patients receiving ZOMETA experienced a skeletal related event (SRE), such as radiation to bone, pathological fractures, and spinal cord compression compared to those receiving placebo. Additionally, patients on ZOMETA had a delay in the onset of the first SRE compared to placebo.

In the trial in lung cancer and other solid tumors (excluding breast and prostate cancer), ZOMETA had a positive impact on median time to the first SRE when compared to placebo.

The results of the prostate cancer trial and the lung cancer and other solid tumor trial mark the first time any bisphosphonate has demonstrated efficacy in treating SREs. U.S. FDA approval of ZOMETA for these indications would mark the first time a bisphosphonate would be available to this patient population. More than 250,000 patients worldwide suffer from bone complications from metastatic prostate cancer.

In the breast cancer and multiple myeloma trial, ZOMETA was as effective and well tolerated as Aredia(R) (pamidronate disodium for injection) - the current standard of treatment - with the added convenience of a 15-minute infusion time versus two-to-four hours for Aredia.

"Before ZOMETA, there was no bisphosphonate therapy available that was effective in all bone metastases regardless of metastatic origin. In particular, there was no effective therapy at all for patients affected with bone metastases resulting from prostate or lung cancer," said James Berenson, MD, Director, Myeloma & Bone Mets Program, Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, California. "The extensive data, combined with the convenient infusion time, suggest ZOMETA may become the new standard of treatment for these patients."

About ZOMETA

ZOMETA is a new generation intravenous (IV) bisphosphonate. Novartis has previously received marketing clearance for ZOMETA in the treatment of hypercalcemia of malignancy (HCM), also known as tumor-induced hypercalcemia (TIH), in the European Union and more than 60 countries, including the United States, Switzerland, Brazil, Canada and Australia.

Contraindications and Adverse Events

In clinical trials in patients with bone metastases, ZOMETA was generally well tolerated with a safety profile similar to other bisphosphonates. The most commonly reported adverse events included flu-like syndrome (fever, arthralgias, myalgias, skeletal pain), fatigue, gastrointestinal reactions, anemia, weakness, cough, dyspnea and edema. Occasionally, patients experienced electrolyte and mineral disturbances, such as low serum phosphate, calcium, magnesium and potassium.

Bisphosphonates, including ZOMETA, have been associated with reports of renal function deterioration. Patients who receive ZOMETA should have periodic evaluations of standard laboratory and clinical parameters of renal function. Doses of ZOMETA should not exceed 4 mg and the duration of infusion should be no less than 15 minutes. ZOMETA should only be used during pregnancy if the potential benefit justifies the risk to the fetus. ZOMETA is contraindicated in patients with clinically significant hypersensitivity to zoledronic acid or other bisphosphonates, or any of the excipients in the formulation of ZOMETA.

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 "recommended approval," "potential," "we believe," "favorable results," "highly effective," "offers significant benefit," and "demonstrated efficacy" or similar expressions, or by discussions of strategy, plans or intentions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with ZOMETA to be materially different from any future results, performance or achievements expressed or implied by such statements. Some of these are uncertainties relating to unexpected regulatory delays, further clinical trial results regarding efficacy or safety of ZOMETA, 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.

About Novartis

Novartis AG (NYSE: NVS) is a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 2000, the Novartis Group's ongoing businesses achieved collective 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. Novartis AG is headquartered in Basel, Switzerland. Novartis Group companies employ about 70,000 people and operate in over 140 countries around the world. For further information please consult www.novartis.com.

Full prescribing information is available upon request. Additional information can be found at www.novartisoncology.com.

Additional information can be found at www.novartisoncologyvpo.com.

        
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