Novartis has filed an application with health authorities in Japan for marketing approval of Zometa (zoledronic acid) injection 4 mg for the treatment of tumor-induced hypercalcemia on 31 October 2002. The filing was based on clinical data from studies conducted in Japan. These Japanese data were compared with results of studies in Western countries, such as the U.S. or members of the European Union. The analysis of data collected from Japanese and Western patient groups, who both received 4 mg of Zometa, showed that 10 days after Zometa treatment, the corrected serum calcium concentrations were comparable (84.0 per cent in patients in Japan, 88.4 per cent in patients in Western countries).

"We believe that Zometa will be an important treatment for patients living with cancer and we will work with health authorities in Japan to help facilitate the approval of this filing." said David Epstein, President Novartis Oncology.

Novartis has received marketing clearance for Zometa in the treatment of tumor-induced hypercalcemia (TIH), also known as hypercalcemia of malignancy (HCM), in more than 70 countries throughout the world. Zometa offers patients and healthcare professionals a convenient 15-minute infusion.

More than 55 countries, including the U.S. and European Union, have already granted marketing authorization to Zometa for the prevention of skeletal-related events in-patients with advanced malignancies involving bone. These malignancies include multiple myeloma, prostate cancer, breast cancer, lung cancer, renal cancer and other solid tumors. This is the broadest range of tumor types in which a bisphosphonate has ever demonstrated efficacy. Based on new clinical data demonstrating the longer-term benefit of Zometa for patients with bone metastases from advanced cancers, Novartis has also submitted a supplemental filing with the U.S. Food and Drug Administration (FDA) to include analyses that confirm the long-term efficacy and safety profile of Zometa in all tumor types studied. They also demonstrate in a multiple-event analysis that 4 mg Zometa infused over 15 minutes further lowered the risk of developing skeletal complications in breast cancer patients with bone metastasis in comparison with pamidronate 90 mg infused over two hours.

TIH affects more than 10 per cent of all cancer patients and generally occurs late in the course of the disease. TIH occurs when factors made by cancer cells overstimulate cells called osteoclasts, which accelerate the breakdown of bone (resorption) and release excess calcium into the bloodstream. The resulting excessively high calcium levels overload the kidneys' processing capability. Clinical trials in TIH with patients from Western countries demonstrated a statistically significant difference favoring Zometa in comparison to the previous treatment standard, Aredia, with respect to the proportion of complete responders. TIH is the most common life-threatening metabolic complication associated with cancer