Quebec Reimburses Novel Blood Cancer Treatment VIDAZA®

VIDAZA Demonstrates Unprecedented Overall Survival in Intermediate-2 and High-
Risk Myelodysplastic Syndromes, as Well as Acute Myeloid Leukemia

OAKVILLE, ON, Jan. 18 /CNW Telbec/ - Quebec patients with serious blood cancers (intermediate-2 and high-risk myelodysplastic syndrome and acute myeloid leukemia) now have publicly funded access to a new innovative therapy, VIDAZA® (azacitidine).  Following a priority review and subsequent positive recommendation from the Conseil du medicament, patients now have the potential to significantly extend survival.

"This decision by the Quebec government is exciting news for patients and will make a huge difference in the way the disease is managed," said Chris Meyer, President, Aplastic Anemia and Myelodysplasia Association of Canada (AAMAC). "We would like to see more Canadians living with MDS and AML benefit from this treatment and we hope that all other provinces follow in the footsteps of Quebec, Ontario, British Columbia and Alberta which also have added VIDAZA to their provincial formularies."

VIDAZA is now reimbursed in Quebec for the treatment of adult patients with intermediate-2 and high-risk myelodysplastic syndrome and acute myeloid leukemia with 20-30% blasts and multi-lineage dysplasia who are not eligible for hematopoietic stem cell transplantation. It represents a new generation of cancer treatments in Canada because it is the first drug that works via epigenetics to restore the normal function of genes that regulate cell growth and development. VIDAZA is the first proven treatment that alters the natural history of these diseases.

"This is without a doubt an important development in the way we treat people with higher-risk MDS and AML," said Dr. Robert Delage, Associate Professor in the Department of Medicine at l'Université Laval and Head of le Centre universitaire d'hématologie et d'oncologie de Québec, at the Hôpital de l'Enfant-Jésus in Québec City. "With VIDAZA we can treat the underlying cause of the disease, rather than merely the symptoms by affecting changes at the genetic level and offer patients, not only freedom from frequent blood transfusions and an improved quality of life, but also a proven chance to live longer."

Celgene is committed to helping to improve the quality of life of people living with rare blood disorders in Canada and will continue to work with officials in all provinces and territories to secure reimbursement for VIDAZA through provincial drug plans.

About MDS
MDS is a group of similar blood disorders that occur when blood cells in the bone marrow do not mature and eventually suppress normal cell development. An estimated 6,000 Canadians are living with MDS and approximately 1,500 new MDS cases are diagnosed each year.

Mean survival rates can range from approximately six to nine months for people with higher-risk MDS.  For roughly 30 per cent of patients diagnosed with this disorder, the abnormal bone marrow cells eventually progress into acute myeloid leukemia (AML), a rapidly growing cancer of the bone marrow cells. 

VIDAZA is approved by Health Canada for the treatment of adult patients with intermediate-2 and high-risk myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) with 20-30% blasts and multi-lineage dysplasia who are not eligible for hematopoietic stem cell transplantation.

VIDAZA is believed to exert its antineoplastic effects by causing hypomethylation of DNA and cytotoxicity of abnormal hematopoietic cells in the bone marrow. DNA hypomethylation of aberrantly methylated genes involved in normal cell cycle regulation, differentiation and death pathways may result in gene re-expression and restoration of cancer-suppressing functions to cancer cells. The cytotoxic effects of VIDAZA cause the death of rapidly dividing cells, including cancer cells that are no longer responsive to normal growth control mechanisms. Non-proliferating cells are relatively insensitive to VIDAZA.

AZA-001, the largest international, randomized, Phase III study ever conducted in patients with higher-risk myelodysplastic syndrome (MDS) was published in the journal The Lancet Oncology in February, 2009. The data indicate that VIDAZA (azacitidine) demonstrated a significant extension of overall survival compared to conventional care regimens (CCR) for patients with intermediate-2 and high-risk MDS and AML with 20 to 30 percent bone marrow blasts.

The median overall survival for patients treated with VIDAZA (n=179) was 24.5 months compared to 15 months for those receiving CCR treatment (n=179), an improvement of 9.5 months (p=0.0001). CCR includes best supportive care, low-dose ARA-C, and standard chemotherapy. There was a 42 percent reduction in the risk of death (0.58 hazard ratio, 95% CI). The two-year survival rate was nearly doubled at 50.8 percent for patients receiving VIDAZA versus 26.2 percent for patients receiving CCR (p=0.0001). The extension of survival was seen across the relevant patient subgroups including those greater than 65 years of age and those with poor cytogenetics, a poor prognostic factor. In addition, 34 percent of patients with AML as classified by the World Health Organization saw a survival benefit.

In addition, 45 percent of patients achieved red blood cell transfusion independence versus 11 percent of patients receiving CCR treatment (p<0.0001) and 85.3 percent of patients treated with VIDAZA who were red-blood-cell transfusion independent at baseline remained so. Investigators aimed to treat patients until disease progression; the median number of cycles of VIDAZA was nine.

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

VIDAZA is a registered trademark of Celgene Corporation.


For further information:

Géraldine Eckert
HKDP Communications and public affairs
514-395-0375, ext. 234

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