Health Canada approves SPRYCEL(TM), a new treatment for chronic myeloid leukemia



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

    MONTREAL, March 28 /CNW Telbec/ - 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(TM)
(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(R)).(1)
    "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(2), 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.(3) The
potential for drug resistance to develop in these patients may increase
depending on the length of prior treatment and the stage of disease.(4) 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.(5) 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.(6) 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.(7)
    "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.(8)

    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.(9) 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.(10)

    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.(11)
    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.

    
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        (TM) Sprycel is a registered trademark of Bristol-Myers Squibb
             Company.

        (R)  Gleevec is a trademark of it's respective owner and not of
             Bristol-Myers Squibb Company


    ----------------------------------
        (1)  SPRYCEL Product Monograph
        (2)  http://www.leukemia-lymphoma.org/all_page?item_id=7026,
             last visit on February 19, 2007
        (3)  http://www.leukemia-lymphoma.org/all_page?item_id=8501,
             last visit on February 19, 2007
        (4)  Shah NP. Hematology. 2005:183-187
        (5)  http://www.cmlsociety.org, last visit on February 20, 2007
        (6)  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.
        (7)  Ibid
        (8)  https://www.sprycel.com/pdf/patient_info.pdf, last visit on
             February 19, 2007
        (9)  Faderi S, Talpeas M, Estrov Z, et al. The Biology of Chronic
             Myeloid Leukemia. N Engl J Med 1999;341(3):164-172
        (10) http://
             www.medterms.com/script/main/art.asp?articlekey=4870,
             last visit on February 19, 2007
        (11) SPRYCEL Product Monograph
    




For further information:

For further information: Marc Osborne, Director, Public Relations,
Bristol-Myers Squibb Canada, (514) 333-2463, marc.osborne@bms.com; Julie
Holroyde, H&K Health, Hill & Knowlton Toronto, (416) 413-4625,
julie.holroyde@hillandknowlton.ca; Peter Gay, H&K Health, Hill & Knowlton
Toronto, (416) 413-4732, peter.gay@hillandknowlton.ca

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