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Health Canada Approves Sprycel™, a New Treatment for Chronic Myeloid Leukemia

Categories: Chronic myeloid leukemia (CML) | Sprycel

Molecular breakthrough offers new hope for patients with life-threatening form of blood cancer who fail or intolerant to current therapies

MONTREAL, CANADA – (March 28, 2007) – Canadians living with chronic myeloid leukemia (CML) have been given renewed hope in their fight against this rare but often life-threatening disease. Health Canada has granted a Notice of compliance under the Notice of Compliance with Conditions for SPRYCEL™ (dasatinib) for treatment of adults with chronic, accelerated or blast phase CML who fail or are intolerant to prior therapy including imatinib mesylate (marketed as Gleevec®).[i]

“Patients lose hope when they're told by their physician that their treatment isn't working for them,” said Rudy Punts, CEO of the Leukemia and Lymphoma Society of Canada. “Thanks to research and development, new therapies offer promise to patients who have run out of options. The approval of SPRYCEL is really good news for these patients.”

CML, one of four types of leukemia[ii] is a slowly progressing cancer of the blood and bone marrow that is characterized by an overproduction of white blood cells which ultimately crowd out the healthy red-blood cells.[iii] The potential for drug resistance to develop in these patients may increase depending on the length of prior treatment and the stage of disease.[iv] It is therefore an understandably devastating event for CML patients to be told that they are intolerant to or are resistant to standard treatment.

“We know that CML primarily affects adults and accounts for about 15% of all leukemias,” said Cheryl-Anne Simoneau, President and CEO of the CML Society of Canada. “In Canada, there are approximately 460 new cases each year, which represents 1 case for every 100,000 people.[v] Each CML case is unique to that patient and not all patients are going to respond to first-line treatments. This is why SPRYCEL represents an important advance for the treatment of CML in patients who have failed or did not respond to previous therapies.”

The Unmet Medical Need

Canadian hematologists and oncologists recognize that there is currently an unmet medical need for the 20-30 percent of chronic and advanced phase CML patients who fail to respond or are intolerant to imatinib. In a recent pan-Canadian survey, an overwhelming 83% of hematologists agreed that there is a need for additional therapy to treat these CML patients.[vi] Furthermore, 76% of respondents believe that a new drug treatment can provide better therapeutic success to the same patients who are resistant to other treatments.[vii]

“Early clinical data show that patients achieved hematologic and cytogenetic responses across all phases of CML,” said Dr. Jeff Lipton, Medical Oncologist and Associate Professor of Medicine at the University of Toronto. “Through its unique mode of action, SPRYCEL shuts down the cancer cell and ultimately the CML. Since cytogenetic response is associated with a survival benefit,it is reasonable to expect that this treatment will allow patients to keep their condition under control for a very long period of time.”

SPRYCEL is a multi-targeted inhibitor and works at various sites within the abnormal cell. It has a unique mode of action which targets multiple pathways associated with CML and reduces the activity of one or more proteins responsible for the uncontrolled growth of the leukemia cells. This reduction allows the bone marrow to resume production of normal red cells, white cells, and platelets.[viii]

About CML

CML is distinguished from the other types of leukemia by a genetic abnormality in the white blood cells called the Philadelphia chromosome which promotes the growth of leukemia cells and seems to be present in nearly 90 per cent of CML cases.[ix]. The Philadelphia chromosome is thought to be acquired after birth and is formed when two chromosomes (9 and 22) switch some of their gene material, forming a new chromosome. [x]

Efficacy and Safety

SPRYCEL is indicated for the treatment of adults with chronic, accelerated or blast phase chronic myeloid leukemia with resistance or intolerant to prior therapy including imatinib mesylate.[xi]

Health Canada issued a marketing authorization for SPRYCEL 20 mg, 50 mg and 70 mg tablets to reflect the promising nature of the clinical efficacy and safety of SPRYCEL in patients with this serious disease and the need for further follow-up to verify the clinical benefit. This approval is based on the rates of hematologic and cytogenetic responses in six clinical studies (one Phase I dose escalation and five phase II multicenter studies) in patients resistant to or intolerant of treatment with imatinib.

SPRYCEL is already available in more than 25 countries including the United States, Austria, Germany, France, Sweden and the United Kingdom.

About Bristol-Myers Squibb Canada

Bristol-Myers Squibb Canada is an indirect wholly-owned subsidiary of Bristol-Myers Squibb Company, a global pharmaceutical and related health care products company whose mission is to extend and enhance human life. Bristol-Myers Squibb Canada is a leading provider of medicines to fight cancer, cardiovascular and metabolic disorders, infectious diseases (including HIV/AIDS), nervous system diseases and serious mental illness. Bristol-Myers Squibb Company is listed on the New York Stock Exchange under the BMY symbol. Bristol-Myers Squibb Canada's operations are headquartered in Montréal, Québec.

For further information, please contact:

Sabrina Tremblay
Senior Manager of Public Affairs
Bristol-Myers Squibb Canada
514-333-2463
[email protected]

Julie Holroyde
Hill and Knowlton, Toronto
416-413-4625
[email protected]

™Sprycel is a registered trademark of Bristol-Myers Squibb Company. ®Gleevec is a trademark of it's respective owner and not of Bristol-Myers Squibb Company

[i] SPRYCEL Product Monograph
[ii] http://www.leukemia-lymphoma.org/all_page?item_id=7026, last visit on February 19, 2007
[iii] http://www.leukemia-lymphoma.org/all_page?item_id=8501, last visit on February 19, 2007
[iv] Shah NP. Hematology. 2005:183-187
[v] http://www.cmlsociety.org, last visit on February 20, 2007
[vi] The pan-Canadian survey was conducted by CROP. A sample of over one-quarter of physicians specializing in hematology was questioned specifically about CML between January 16 and February 12, 2007. All respondents are either currently treating CML patients or have treated a CML patient in the past 12 months, 71% practice in a hospital centre and 29% practice in a regular hospital. The data gathered from the survey were in response to a written questionnaire.
[vii] Ibid
[viii] https://www.sprycel.com/pdf/patient_info.pdf, last visit on February 19, 2007
[ix] Faderi S, Talpeas M, Estrov Z, et al. The Biology of Chronic Myeloid Leukemia. N Engl J Med 1999;341(3):164-172
[x] http://www.medterms.com/script/main/art.asp?articlekey=4870 [xi]SPRYCEL Product Monograph

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