REVLIMID Receives Positive Final Appraisal Determination from National Institute for Health and Clinical Excellence (NICE) for Use in the National Health Service (NHS) in England and Wales
BOUDRY, Switzerland, Apr 23, 2009 (BUSINESS WIRE) -- CELG | Quote | Chart | News | PowerRating -- Celgene International Sarl (Nasdaq:CELG) today announced that the National Institute for Health and Clinical Excellence (NICE) has issued a Final Appraisal Determination (FAD) recommending REVLIMID, in combination with dexamethasone, within its licensed indication, as an option for the treatment of patients in England and Wales with multiple myeloma who have received two or more prior therapies. NICE determined that REVLIMID, as an innovative, life-extending therapy, is a cost-effective use of National Health Service (NHS) resources.
The recommendation also states that the drug cost of REVLIMID (excluding any related costs) for patients who remain on treatment for more than 26 cycles (each of 28 days; normally a period of two years) will be met by Celgene.
For patients currently receiving REVLIMID for the treatment of multiple myeloma, but who have not received two or more therapies, the FAD provides the option to continue therapy until they and their clinicians consider it appropriate to stop.
"We welcome the positive FAD from NICE and applaud the organization's emphasis on providing access to therapies that enable patients in the U.K. to live longer, more productive lives," said Sol J. Barer, Ph.D., Chairman and CEO 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 during the second quarter of 2009.
NICE's evaluation considered peer-reviewed clinical studies that demonstrated REVLIMID offers unsurpassed survival, deep and durable responses that improve over time and a manageable side-effect profile that is acceptable for long-term use.
"Multiple myeloma is still an incurable blood cancer, however, new therapies like REVLIMID are offering significant extensions of survival for patients and moving the disease toward becoming a chronic, manageable condition," said Gareth Morgan, Professor of Haematology, Royal Marsden NHS Foundation Trust. "The FAD issued by NICE is a major step toward providing a critical new option for patients in the U.K."
REVLIMID(R) is currently approved in the European Union, United States, Canada, Switzerland and certain Latin American countries in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy and in Australia and New Zealand in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy. REVLIMID is also approved in Canada, the United States, Peru and Argentina for transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. REVLIMID has obtained Orphan Drug designations for a variety of haematologic indications in the EU, U.S., Switzerland and Australia and Japan.
About REVLIMID
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 oncological conditions, both in blood cancers and solid tumors. The IMiDs pipeline is covered by a comprehensive intellectual property estate of U.S. and foreign issued and pending patent applications including composition-of- matter and use patents.
About Multiple Myeloma
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 International Sarl
Celgene International Sarl, located in Boudry, in the Canton of Neuchatel, 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, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company's filings with the Securities and Exchange Commission such as Form 10-K, 10-Q and 8-K reports.