BOUDRY, Switzerland, Feb 16, 2011 (BUSINESS WIRE) --
Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (Nasdaq:CELG) today announced that the National Institute for Health and Clinical Excellence (NICE) has issued a Final Appraisal Determination (FAD) recommending VIDAZA within its licensed indication, as an option for the treatment of patients in England and Wales with myelodysplastic syndromes (MDS) and acute myeloid leukaemia. NICE determined that VIDAZA, as an innovative, life-extending therapy, is a cost-effective use of National Health Service (NHS) resources.
"We applaud the positive FAD from NICE that will provide patients more widespread access to a therapy that has been shown to prolong survival in these incurable blood cancers," said Robert J. Hugin, Chief Executive Officer of Celgene Corporation.
The FAD issued today has been sent to the appraisal consultees who may appeal the decision within 15 days. If there is no appeal, NICE may use the FAD to form the basis of its final guidance to the NHS, expected in the first half of 2011.
NICE's evaluation considered peer-reviewed clinical studies that demonstrated VIDAZA extended the lives of patients with MDS by more than nine months compared to conventional care regimens.
In December 2008, VIDAZA became the first and only drug approved by the European Commission to demonstrate a significant extension of overall survival compared to conventional care regimens, for patients with Intermediate-2 and high-risk MDS and AML (20-30% blasts). Earlier in 2008 the U.S. FDA also included this extension of overall survival in its approved VIDAZA indication for treatment of all five French, American, British (FAB) MDS subtypes, which includes both low-risk and high-risk patients. These subtypes include: refractory anemia (RA), Refractory anemia with ringed sideroblasts (RARS) if accompanied by neutropenia, or thrombocytopenia or requiring transfusions, Refractory anemia with excess blasts (RAEB), Refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukaemia (CMML). The more recent WHO classification system incorporates RAEB-T patients within the AML category. VIDAZA has received orphan drug designation in several markets including the European Union, the U.S. and Japan.
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. VIDAZA was approved by FDA for IV administration in January 2007.
IMPORTANT SAFETY INFORMATION
Nursing mothers should be advised to discontinue nursing or the drug, taking into consideration the importance of the drug to the mother
About Celgene International Sàrl
Celgene International Sàrl, located in Boudry, in the Canton of Neuchâtel, Switzerland, is a wholly owned subsidiary and international headquarters of Celgene Corporation. Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative 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.
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company's control. The Company's actual results, performance, or achievements could be materially different from those projected by these forward-looking statements. The factors that could cause actual results, performance, or achievements to differ from the forward-looking statements are discussed in the Company's filings with the Securities and Exchange Commission, such as the Company's Form 10-K, 10-Q and 8-K reports. Given these risks and uncertainties, you are cautioned not to place undue reliance on the forward-looking statements.
SOURCE: Celgene International Sàrl
Celgene International Sàrl
Kevin Loth, +41 32 729 86 21
Director of External Relations