~ Zometa®, first treatment approved for bone complications associated with advanced prostate cancer ~
Dorval, Quebec (October 9, 2002) -- For 75 per cent of advanced prostate cancer patients, the complications of bone metastases, or the spread of the cancer to their bones, is a constant, painful reminder of their struggle with this disease. Now, with the approval of Zometa® (zoledronic acid for injection) for the treatment of bone metastases due to prostate cancer, these patients, for the first time, have access to a treatment that can ease their pain and restore their quality of life.
Granted priority review by Health Canada, Zometa® has been approved for the treatment of complications from bone metastases due to prostate cancer in conjunction with standard antineoplastic therapy, including both chemotherapy and hormonal therapies. Priority review is granted to those drugs which are shown to fill a significant unmet medical need. Before the approval of Zometa®, there was no effective treatment that specifically targets the bone metastases resulting from prostate cancer.
Zometa® data published in the Journal of the National Cancer Institute represents the first and only large-scale, randomized trial to demonstrate significant efficacy in the treatment of painful and debilitating cancer-related bone complications.
"The results show that these men experience fewer events such as fractures, bone lesions, and spinal cord compression and have a slower progression of pain," said Dr. Fred Saad, Urologist-Oncologist at Notre-Dame Hospital at the University of Montreal and Lead Trial Investigator. "With this approval we finally have a treatment that specifically targets the bone metastases associated with prostate cancer, and that can delay the development of the related skeletal events. For the patient, this means extended time without having to live with the repercussions of fractures and pain."
"Advanced prostate cancer commonly spreads to the bone and causes a variety of complications that can significantly impact a patient's day-to-day activities. Until now, there were no effective treatments available to treat this group of patients," said Dr. Neil Fleshner, head of the Division of Urology at the University Health Network (incorporating Princess Margaret Hospital). "Zometa® represents a significant advance in the overall treatment of advanced prostate cancer patients, and is a welcome therapeutic addition."
BONE METASTASES IN PROSTATE CANCER
Second only to lung cancer as the leading cause of death by cancer in men, prostate cancer will affect one in every eight men in their lifetime.1 If prostate cancer progresses to the advanced stage, a common complication is that the cancer will spread, or metastasize, to the bone resulting in severe bone pain, fractures, bone lesions, spinal cord compression and the need for additional radiation or surgery. In fact, the effects of bone metastases are the leading cause of death among patients who die from the complications of prostate cancer.
"I am fortunate that my prostate cancer treatment has been working for me," said John Lally, prostate cancer patient. "I am relieved to know that if my cancer spreads to my bones there is a treatment available that will maintain my quality of life."
CLINICAL DATA
The trial that led to the approval of Zometa® marks the first time any drug has demonstrated efficacy in treating bone complications in patients with prostate cancer.
In the international trial involving 422 prostate cancer patients with a history of metastatic bone disease, patients were given either a 15-minute infusion of Zometa® (4 mg), or a placebo every three weeks for a period of 15 months.
By the end of the trial, 25 per cent fewer patients taking Zometa® experienced any skeletal related events, such as fractures, and spinal compression, compared to those taking placebo. As well, it was shown that Zometa® significantly delayed the time to the first skeletal-related event such as fractures, and patients taking Zometa® experienced less bone pain than those taking placebo.
"The results of the clinical trial were seen to be highly significant because they show that a patient's quality of life, and his ability to be active, were extended through treatment with Zometa®," said Dr. Fleshner. "For patients with advanced disease, who never before have had the option of treatment of this painful complication, these results are highly compelling."
ABOUT Zometa®
Zometa® belongs to a class of drugs called bisphosphonates, often referred to as 'bone builders.' Zometa® is the most powerful of the bisphosphonates, and works in two distinct ways. It stops bones from weakening by inhibiting a process called resorption, and helps stabilize bone metabolism to keep bones strong.
Zometa® is given to patients every three to four weeks in a simple and convenient infusion that takes only 15 minutes.
"At Novartis we are committed to developing innovative and practical new treatments for patients with cancer," said Dr. Jean-Marie Leclerc, Vice President Medical, Novartis Oncology. "With this approval, Zometa® offers physicians and patients a new, broadly effective and convenient treatment for the debilitating bone complications of prostate cancer."
Zometa® was previously approved in Canada for the treatment of hypercalcaemia of malignancy (HCM), also known as tumor-induced hypercalcaemia (TIH), in August 2000.
In clinical trials, Zometa® was generally well tolerated, with a safety profile similar to other bisphosphonates. The most commonly reported adverse events were similar for both placebo and Zometa® treatment groups, and most of these experiences may have been related to the underlying disease state or cancer therapy. Commonly reported adverse experiences included bone pain, nausea, constipation, fatigue, anemia NOS, myalgia, vomiting NOS, weakness and pyrexia.
FORWARD LOOKING STATEMENT
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 "mark the first time," "offers," "innovative," "new treatments," "important addition," and "significantly impact" 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 CANADA
Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well being of all Canadians. Novartis Pharmaceuticals Canada conducts hundreds of clinical trials across the country seeking new treatments for cardiovascular disease, diabetes, cancer, organ transplantation and glaucoma. In 2001, the Company invested $34 million in research and development. Novartis Pharmaceuticals Canada Inc. employs approximately 650 people in Canada and its headquarters are located in Dorval, Quebec. In addition to Novartis Pharmaceuticals Canada Inc., the Novartis Group in Canada consists of Novartis Animal Health Canada Inc., Novartis Consumer Health Canada Inc., (including Novartis Nutrition Corporation and Gerber [Canada] Inc.) and CIBA Vision Canada Inc.
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