Canada Approves Zoledronic Acid

DORVAL, QC -- August 29, 2000 -- Novartis Pharmaceuticals Canada Inc. announced that it has received marketing authorization from the Canadian Therapeutic Products Programme for Zometa* (zoledronic acid), a highly potent intravenous (IV) bisphosphonate, for the treatment of hypercalcaemia of malignancy (HCM) also known as tumour-induced hypercalcaemia (TIH), one of the most common life-threatening metabolic complications associated with cancer. This is the first marketing clearance Novartis has received for the agent worldwide.

The application for approval was based on a global clinical trial program involving 287 patients. In this program, Zometa demonstrated superior efficacy to Aredia* (pamidronate), the current treatment of choice for TIH, and was equally well tolerated. The new drug also normalised serum calcium levels significantly faster than Aredia and for a longer duration. In addition, because of Zometa's superior potency, the recommended duration of infusion is only fifteen minutes, versus two hours for Aredia, which is a distinct benefit for patients and clinicians.

"Zometa's efficacy in TIH is impressive," said Dr. Beat Suemegi, Vice President, Medical Affairs, Novartis Pharmaceuticals Canada Inc. "Early diagnosis and treatment can be lifesaving and may ultimately enable the patient to complete cancer therapy."

TIH can occur with virtually any tumour type but is associated more frequently with lung cancer, breast cancer and multiple myeloma. It affects more than ten percent of all cancer patients and most often occurs in advanced cancer, in patients with or without bone metastases. TIH occurs when cells known as "osteoclasts" decompose the bone and release excess calcium into the bloodstream. Because the kidneys cannot process the calcium overload, TIH -- if not treated -- usually leads to severe dehydration and can cause death. Zometa normalises elevated levels of serum calcium in TIH by inhibiting the abnormal activity of osteoclasts.

"Zometa is slated to replace Aredia and reflects our continued commitment to explore Zometa's potential in other oncology settings," said David Epstein, President, Novartis Oncology.

"Phase III clinical trials currently are already evaluating Zometa's effectiveness in treating bone metastases and preventing the skeletal complications of bone metastases, such as bone fractures, in women with breast cancer."

Dr. Suemegi said Novartis plans to launch Zometa in Canada in October. Zometa was granted a priority evaluation status in Canada. Similar applications for marketing approval are currently under review in the United States, Switzerland and the EU.

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