DORVAL, Quebec (October 28, 2003 ) — Newly diagnosed adult patients with Philadelphia chromosome positive, chronic myeloid leukemia (Ph+ CML), will now benefit from a significant treatment advance. Health Canada has approved Gleevec® (imatinib mesylate) for the treatment of Ph+ CML in newly diagnosed adult patients. Gleevec®, the first cancer treatment in the world specifically targeting a cancer-producing molecule and 'switching off' the malfunction, leaving healthy cells intact, has been recently awarded the 2003 Prix Galien for most Innovative Drug Product. A jury of leading Canadian specialists involved in medical and pharmaceutical research selected Gleevec® for this Award, which represents the most prestigious prize for medical innovation in Canada.
"Gleevec® has been a life-saving product for me," said Louis Nault, a Gleevec® patient. "The news that Gleevec® will now be available for all patients with CML, from newly diagnosed CML patients to late-stage patients, is really exciting. When diagnosed, I was devastated with the news and my prognosis was bleak. I was in very poor health and had very little hope for the future, and now my cancer is in remission. I have renewed energy and appetite, and for the first time I feel that I have gained control over my disease and my overall life has improved substantially," added Mr. Nault.
CLINICAL DATA SHOWS SUPERIORITY OF Gleevec®
Results from the International Randomized Study of Interferon vs. Gleevec® (IRIS), recently published in The New England Journal of Medicine, found that Gleevec® was superior to traditional therapy in the first-line treatment of adults with newly diagnosed Ph+ CML. The head-to-head study involving 1,106 patients including Canadian patients, compared Gleevec® with a traditional treatment for CML - a combination of interferon-alpha and cytosine arabinoside (a type of chemotherapy for leukemias and lymphomas).
After 18 months of follow-up in the study, 76.2 per cent of newly diagnosed patients treated with Gleevec®, taken orally at 400 mg daily, no longer had evidence of the disease, compared with 14.5 per cent of those treated with the traditional combination therapy. In addition, the study showed Gleevec® significantly delayed the progression of CML to the advanced stages of the disease, as well as improved the quality of patient lives.
"This difference between treatment options is rarely, if ever, seen in the direct comparisons of cancer drugs. Thus based on this encouraging scientific data, Health Canada has made a significant treatment available to Canadian patients," said Dr. Pierre Laneuville, Director of the Division of Hematology at McGill University Health Centre. "The data clearly shows the continued superior results of Gleevec® relative to what had been previously considered the traditional therapy. Physicians will now be able to provide Gleevec® to newly diagnosed CML adult patients, and this is extremely promising news as our goal in treatment is to ensure that our patients can return to normal, productive lives."
"The medical community has, for many years, stressed the importance of early detection and treatment for all types of cancer as the most effective way to achieve the best clinical outcome," said Dr. Laneuville. "Gleevec® has demonstrated its superiority in reducing and eliminating Philadelphia chromosomes from bone marrow when therapy is initiated earlier in the course of the disease. In addition, with early therapy, patients are more likely to experience an improved quality of life compared with those on standard therapy," added Dr. Laneuville.
Gleevec® - AN ADVANCE IN CML THERAPY
The recent approval by Health Canada marks the third indication for Gleevec® in 24 months in Canada. In addition to the treatment of newly diagnosed adult patients with Ph+ CML, Gleevec® is also indicated for the treatment of adult patients with CML in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy, in 80 countries, including Canada. Gleevec® is also indicated for the treatment of adult patients with unresectable (inoperable) and/or metastatic malignant gastrointestinal stromal tumors (GISTs).
FORWARD-LOOKING STATEMENT
The foregoing release contains forward-looking statements that can be identified by terminology such as "significantly," "substantially," "advance," or similar expressions, or by discussions regarding potential new indications for Gleevec®, or regarding the long-term impact of a patient's use of Gleevec®. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Gleevec® to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Gleevec® will be approved for any additional indications in any market. Neither can there be any guarantee regarding the long-term impact of a patient's use of Gleevec®. In particular, management's ability to ensure satisfaction of the health authorities further requirements is not guaranteed and management's expectations regarding commercialization of Gleevec® could be affected by, among other things, additional analysis of Gleevec® clinical data; new clinical data; unexpected clinical trial results; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; and other risks and factors referred to in the Company's current Form 20-F on file with the US 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 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 Inc. conducts hundreds of clinical trials across the country seeking new treatments for cardiovascular disease, diabetes, cancer, organ transplantation and glaucoma. In 2002, the Company invested $35 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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