Press Releases / Notices

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NEWS 2011

January 21, 2011 Pharmaceuticals


KYOTO, JAPAN - (January 21, 2011) – Nippon Shinyaku Co., Ltd. today announced that VIDAZA® (azacitidine) for Injection 100 mg has been granted marketing authorization by the Ministry of Health, Labour and Welfare (MHLW) of Japan for the treatment of patients with myelodysplastic syndromes (MDS).

Myelodysplastic syndromes (MDS) are a group of hematologic malignancies with a poor prognosis that may progress to acute myeloid leukemia and affect approximately 300,000 people worldwide. Typical symptoms include fatigue associated with anemia and increased susceptibility to infections associated with leukocytopenia.  Red blood cell transfusion is often necessary for the patients with MDS, however this can cause complications, such as iron overload, multi-organ toxicity and others.

The approval of VIDAZA was based upon the safety and efficacy results of several randomized international trials in patients with MDS, including a phase 1/2 study with Japanese patients.

In Japan, MDS are designated as intractable diseases and the estimated prevalence of MDS in Japan is currently about 9,000 cases. There has been an increasing demand for the development of agents to address the unmet medical needs for better therapeutic approaches for MDS. 

As a result of the approval, VIDAZA will be available in Japan as part of a licensing agreement with Celgene Corporation, the developers of the therapy, with a starting dosage of 75 mg/m2 by subcutaneous injection or intravenous infusion (10 minutes) once daily for 7 days every 4 weeks.

Upon drug price listing, Nippon Shinyaku is planning to launch VIDAZA in Japan.
VIDAZA is the lyophilized product for injection containing the nucleoside derivative azacitidine as its active ingredient and has already been marketed in more than 30 countries including the United States and in Europe. In addition, the Japanese regulatory authority granted VIDAZA orphan designation for the treatment of MDS in November 2008. In addition, VIDAZA, in an international, multicenter, randomized study of higher-risk MDS patients, has demonstrated a statistically significant difference in overall survival compared to patients treated with conventional care regiments (CCR) (24.5 months compared to 15.0 months).

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.

About Myelodysplastic Syndromes
Myelodysplastic syndromes occur when blood cells remain in an immature or “blast” stage within the bone marrow and never develop into mature cells capable of performing their necessary functions. Eventually, the bone marrow may be filled with blast cells suppressing normal cell development. MDS patients must often rely on blood transfusions to manage symptoms of anemia and fatigue and may develop life-threatening iron overload and/or toxicity from frequent transfusions, thus underscoring the critical need for new therapies targeting the cause of the condition rather than simply managing its symptoms.

VIDAZA® is a registered trademark of Celgene Corporation.