Revlimid(R) Receives Preliminary Positive Recommendation From NICE For Use In The NHS In England And Wales

Main Category: Lymphoma / Leukemia / Myeloma
Also Included In: Blood / Hematology;  Cancer / Oncology;  Regulatory Affairs / Drug Approvals
Article Date: 30 Jan 2009 - 4:00 PDT

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Celgene International Sàrl (Nasdaq:CELG) today announced that the company has received a preliminary positive recommendation from NICE for the use of REVLIMID in the NHS in England and Wales. The recommendation specifies the use of REVLIMID, in combination with dexamethasone, as an option for the treatment of patients with multiple myeloma who have received two or more prior therapies.

"This recommendation from NICE is a welcome recognition of the increasing value innovative medicines provide to patients and healthcare systems," said Sol J. Barer, Ph.D., Chairman and CEO of Celgene Corporation. "In particular, REVLIMID offers patients a convenient, long-term, continuous therapy that suppresses their disease and enables them to live longer, more productive lives."

According to new evaluation criteria for innovative, life-extending therapies recently adopted by NICE, REVLIMID is considered a cost-effective use of NHS resources. This 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.

"The preliminary recommendation to make REVLIMID available on the NHS is fantastic news for patients. REVLIMID produces a remarkable effect on survival in this difficult-to-treat and cruel cancer and this action is an excellent example of industry, NICE and the NHS working together for the benefit of patients," said Gareth Morgan, Professor of Haematology, Royal Marsden NHS Foundation Trust.

The preliminary recommendation will now undergo consultation, leading to a third appraisal committee meeting, scheduled to take place near the end of the first quarter of 2009. A final recommendation and final guidance are expected during the second quarter of 2009.

REVLIMID® is currently approved in the European Union, United States, Canada, Argentina, Peru and Switzerland 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 hematologic indications in the EU, U.S., Switzerland and Australia and Japan.

About REVLIMID

REVLIMID is an IMiDs® 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 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 http://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.

Celgene International Sàrl