Celgene Announces New Drug Application Filing for REVLIMID® in Japan
REVLIMID filing based on safety and efficacy results of two large, randomised pivotal Phase III trials, as well as specific Japanese studies
NDA is for REVLIMID in combination with dexamethasone for multiple myeloma patients who have received at least one prior therapy
BOUDRY, Switzerland--(BUSINESS WIRE)--Celgene International Sàrl (NASDAQ:CELG) today announced it has filed a New Drug Application (NDA) with the Japanese Ministry of Health, Labour and Welfare (MHLW) for REVLIMID (lenalidomide) in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. Approximately 11,000 people in Japan suffer from multiple myeloma and around 4,000 patients are diagnosed each year.
"The filing of an NDA in Japan for multiple myeloma represents an important step towards achieving our goal of delivering REVLIMID to patients in need in one of the world's largest oncology populations," said Joseph Melillo, General Manager of Celgene KK.
The filing with the MHLW is based upon the safety and efficacy results of two large, randomised pivotal Phase III special protocol assessment trials: North American Trial MM-009 and International Trial MM-010 evaluating REVLIMID plus dexamethasone in multiple myeloma patients who have received at least one prior therapy. Both studies were published in the New England Journal of Medicine in November 2007. Phase I clinical results with Japanese patients, including those from MM-017, confirm similar efficacy and further support the filing.
REVLIMID was granted orphan drug status in February 2008 by the MHLW in Japan for two indications - the treatment of anaemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenic abnormality with or without other cytogenic abnormalities, and in combination with dexamethasone for multiple myeloma patients who have received at least one prior therapy.
REVLIMID is approved in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy in nearly 50 countries, encompassing Europe, the Americas, the Middle-East and Asia, and in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy in Australia and New Zealand.
REVLIMID® is also approved in the United States, Canada and several Latin American countries, as well as Malaysia and Israel, for transfusion-dependent anaemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Marketing Authorisation Applications are currently being evaluated in a number of other countries.
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 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, Switzerland, is a wholly owned subsidiary and international headquarters of Celgene Corporation. Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical 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.
REVLIMID® is a registered trademark of Celgene Corporation.
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.