~ Breakthrough Oral Cancer Drug, Discovered and Developed by Novartis, Approved for Chronic Myeloid Leukemia ~
DORVAL, Quebec (September 24, 2001) -- Novartis Pharmaceuticals Canada Inc. today announced the Health Canada approval of Gleevec® (imatinib mesylate), an oral therapy for the treatment of chronic myeloid leukemia (CML) in blast crisis, accelerated phase or chronic phase after failure of interferon-alpha therapy (a current standard therapy). Gleevec® is the first cancer treatment to be developed with rational drug design, based on an understanding of how cancer cells work. The drug addresses the genetic malfunction that is present in CML patients.
Gleevec® has been designed to block the function of an abnormal protein, Bcr-Abl, present in CML. The preciseness by which the drug targets the cancer cell differentiates Gleevec® from most other oncology products. In clinical trials conducted in patients with chronic phase CML after interferon failure, close to 90 per cent of patients had white blood cell counts return to normal and approximately 50 per cent had a major1 cytogenetic response (measure of the percentage of cells that are positive for the Philadelphia (Ph) chromosome, a common marker for CML).
"We have rarely seen such dramatic results in a leukemia treatment as we have with Gleevec®," said Dr. John Shepherd, Clinical Associate Professor at the University of British Columbia, and Bone Marrow Transplant Hematologist at the British Columbia Cancer Agency. "It is a truly exciting option to have for our patients, and marks an important development for the future of cancer research and treatment."
Gleevec® was submitted for approval in Canada on March 1, 2001. Health Canada assigned a Priority Evaluation Status to the dossier for Gleevec® and has approved the product under a Notice of Compliance with Conditions (NOC-C). NOC-C allows the approval of drugs for serious or life-threatening illnesses based on clinical trials that establish that the drug has a positive effect on a surrogate endpoint that reasonably predicts clinical benefit. Long-term safety data are not available and drug interaction data are limited. Confirmatory studies with Gleevec® are ongoing. To date, Gleevec® has been approved in the United States, Switzerland, Australia, Mexico, Korea, Argentina, Guatemala, Peru, Romania, Syria, Jordan and Canada.
CHRONIC MYELOID LEUKEMIA
Chronic myeloid leukemia (CML) is a stem cell disorder resulting from an acquired or induced abnormality in the DNA of the stem cells in bone marrow. CML is caused by a so-called 'reciprocal translocation' between chromosomes 9 and 22, resulting in the "Philadelphia chromosome," a well-known marker for CML. As a result of reciprocal translocation, a new and abnormal protein, Bcr-Abl, causes the uncontrolled proliferation of white blood cells. CML progresses through three distinct phases: the chronic phase (typically lasting from four to five years), the accelerated phase (typically lasting from six to 18 months) and blast crisis (typically lasting from three to six months). Each phase is marked by a progressive increase in the number of white blood cells. CML is one of the four most common types of leukemia. Approximately 3,500 Canadians are diagnosed each year with leukemia, and 2,100 will die.
"Starting Gleevec® was like having my own personal miracle," said Gleevec® patient, Neils Hansen-Trip. "Who would believe that life starts again at 54 - thanks to Gleevec® mine did."
CLINICAL RESEARCH AND EXPERIENCE
"Upon the first hint of the potential of Gleevec®, Novartis committed to increasing investment in manufacturing and clinical development, allowing many more patients to enter clinical studies and have access to Gleevec®," said Jean-Francois Pouliot, PhD, Medical Advisor - Oncology, Novartis Pharmaceuticals Canada Inc. "Early on we saw the tremendous benefit of this medication, and Novartis was able to initiate an expanded clinical trial program to help patients with CML, and other forms of cancer for which trials are still ongoing."
More than 7,500 patients at 490 sites in 30 countries are currently being treated for CML with Gleevec®. Of these patients, approximately 5,000 are part of an expanded access program, which was established to provide access to patients who were in medical need. Gleevec® is currently being used in the treatment of greater than 225 Canadians with CML.
The approval of Gleevec® is based on data from three Phase II open-label, single arm studies that showed a major cytogenetic response in patients with advanced stages of CML (21 per cent in the accelerated phase and 14 per cent in myeloid blast crisis), as well as hematologic responses for patients in accelerated phase and myeloid blast crisis (63 per cent and 26 per cent, respectively). Patients with chronic phase CML after failure with interferon therapy achieved an 88 per cent hematologic response and 49 per cent major cytogenetic response, both primary endpoints of the study. The effectiveness of Gleevec® is based on overall hematologic and cytogenetic response rates. Novartis is currently conducting studies to evaluate whether Gleevec® provides improved survival.
The majority of patients treated with Gleevec® experienced adverse events at some time. Most events were mild to moderate, however the drug was discontinued for adverse events in one per cent of patients in chronic phase, two per cent in accelerated phase and five per cent in blast crisis.
Forward-Looking Statements
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 "potential," "showed," "currently underway," or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of a new product, Gleevec®, for which the company has filed global marketing applications, and anticipated customer demand for such products. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of Gleevec® to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements.
Some of these are uncertainties relating to unexpected regulatory delays, future clinical trial results, 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 (NYSE: NVS) is a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 2000, the Group's ongoing businesses achieved sales of $25.5 billion and invested approximately $3.5 billion in R&D. Headquartered in Basel, Switzerland, Novartis employs about 67,600 people and operates in over 140 countries around the world.
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