New Oral Therapy for Blood Cancer Approved in Canada



    
    Unprecedented Overall Survival Data for Revlimid(R) gives Renewed Hope to
    Multiple Myeloma Patients with Advanced Disease
    

    OAKVILLE, ON, Oct. 6 /CNW/ - Health Canada has approved Revlimid(R)
(lenalidomide), a new treatment with proven ability to increase overall
survival and slow disease progression, in combination with dexamethasone, for
the treatment of multiple myeloma patients who have received at least one
therapy. Prior to approval, there were few effective, once-daily oral
treatment options available for patients with this aggressive blood cancer.
    "The clinical data shows that patients treated with Revlimid and
dexamethasone have superior response rates and for a longer duration,
experience slower progression of disease, and survive longer than we have ever
seen before," said Dr. Darrell White, Hematologist, Nova Scotia Cancer Centre,
Dalhousie University. "This Health Canada approval means that we can now treat
many more patients with this incurable form of cancer."
    Multiple myeloma (MM) is a rare, progressive and fatal blood cancer with
significant morbidity and mortality(1). Incidence increases with age and
median age at diagnosis is between 63 and 70 years of age. Of the estimated
6000 Canadians suffering with the disease, approximately 1000 will die this
year and 2000 new patients will be diagnosed at treatment centres across
Canada.
    "There is no cure for multiple myeloma, but new oral cancer therapies,
like Revlimid, are a step towards changing multiple myeloma into a manageable
chronic disease and thus improving patient quality of life," said Dr. White.
    "Revlimid, a once-daily pill, is the only treatment that was able to
control my cancer after many attempts, including bone marrow transplants,"
said Derek Hunter, a multiple myeloma patient from Saint John, New Brunswick
who was diagnosed in 2003. "My greatest hope is that other patients will be
given the same chance at life by having access to this great treatment."
    The Health Canada approval was based on the results of two Phase III
clinical trials, published in the New England Journal of Medicine, evaluating
Revlimid with dexamethasone in previously treated multiple myeloma patients
which showed an increased overall survival rate and slowed disease
progression(2). Revlimid will be available in 15 mg and 25 mg oral capsules
for the treatment of multiple myeloma after one prior therapy.

    About REVLIMID(R)

    REVLIMID is an IMiDs(R) compound, a member of a proprietary group of
novel immunomodulatory agents. REVLIMID and other IMiDs compounds continue to
be evaluated in over 100 clinical trials in a broad range of hematological and
oncological conditions. The IMiDs pipeline is covered by a comprehensive
intellectual property estate of issued and pending patent applications in the
US, EU and other regions, including composition-of-matter and use patents.

    About Multiple Myeloma

    Multiple myeloma is the second most common blood cancer and represents
approximately 1% of all cancers and 2% of all cancer deaths. The Canadian
Cancer Society reports that there are about 6000 Canadians living with
multiple myeloma, and approximately 2000 new cases are diagnosed each year.(3)
    Multiple myeloma (also known as myeloma or plasma cell myeloma) is a
cancer of the blood in which malignant plasma cells are overproduced in the
bone marrow. Plasma cells are white blood cells that help produce antibodies
called immunoglobulins that fight infection and disease. However, most
patients with multiple myeloma have cells that produce a form of
immunoglobulin called paraprotein (or M protein) that does not benefit the
body. In addition, the malignant plasma cells replace normal plasma cells and
other white blood cells important to the immune system. Multiple myeloma cells
can also attach to other tissues of the body, such as bone, and produce
tumors. The cause of the disease remains unknown.

    About Celgene

    Celgene Corporation is an integrated global biopharmaceutical company
engaged primarily in the discovery, development and commercialization of novel
therapies for the treatment of cancer and inflammatory diseases through gene
and protein regulation. For more information, please visit the Company's
website at www.celgene.com. Revlimid is a registered trademark of Celgene
Corporation.
    Revlimid(R) was granted the Prix Galien USA 2008 Award for Special
Therapeutic Development on September 24, 2008. The Prix Galien Award
recognizes the technical, scientific and clinical research skills necessary to
develop innovative medicines and is considered to be the highest accolade for
pharmaceutical research and development.

    
    ------------------------
    (1) Canadian Cancer Society/National Cancer Institute of Canada. Canadian
        Cancer Statistics 2008. Accessed October 1, 2008 at
        http://www.ncic.cancer.ca/vgn/images/portal/cit_
        86751114/14/35/195991821ncic_stats2004_en.pdf
    (2) New England Journal of Medicine, November 22, 2007
    (3) Canadian Cancer Society. Canadian Cancer Statistics 2008.
        http://www.cancer.ca/
    





For further information:

For further information: Media Contacts: Tara Knight, Celeste Brown,
Hill & Knowlton Canada, (416) 413-4774, (416) 413-4651,
Tara.knight@hillandknowlton.ca, Celeste.brown@hillandknowlton.ca

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