Healthcare Industry News: REVLIMID
News Release - April 7, 2008
Thalidomide Pharmion(R) Receives Marketing Approval from Australian Therapeutic Goods Administration for Treatment of Newly Diagnosed Multiple MyelomaBOUDRY, Switzerland--(HSMN NewsFeed)--Celgene International Sàrl (NASDAQ: CELG ) today announced the Australian Therapeutic Goods Administration (TGA) approved a supplemental filing granting Thalidomide Pharmion marketing approval for use in combination with melphalan and prednisone for patients with untreated multiple myeloma or ineligible for high dose chemotherapy. Additionally, Thalidomide Pharmion was granted marketing approval in combination with dexamethasone for induction therapy prior to high dose chemotherapy with autologous stem cell rescue, for the treatment of patients with untreated multiple myeloma.
This marketing approval represents the first oral cancer therapy ever registered for patients newly diagnosed with multiple myeloma in Australia.
Thalidomide Pharmion was previously approved by the TGA in 2003 as a treatment for patients with multiple myeloma after failure of standard therapies. In January 2008, the TGA granted the Company’s leading oral cancer therapy REVLIMID® full marketing approval for use in combination with dexamethasone as a treatment for patients with multiple myeloma whose disease has progressed after one therapy.
“The TGA approval of Thalidomide Pharmion for newly diagnosed myeloma patients offers additional options in this critical disease area. When coupled with the approval of REVLIMID and dexamethasone earlier this year, we are advancing our goal of delivering vital therapies to patients in need worldwide,” said Aart Brouwer, President of Celgene International. “Additionally, these approvals confirm our leadership role in blood cancer research and innovative oral therapies.”
Multiple myeloma is the second most commonly diagnosed blood cancer worldwide.
About Thalidomide Pharmion
THALOMID® (thalidomide) researched, developed and commercialized by Celgene Corporation, received U.S. Food and Drug Administration (FDA) approval on May 25, 2006 as an oral treatment in combination with dexamethasone for patients newly diagnosed with multiple myeloma. In 2003, the Australian Drug Evaluation Committee approved Thalidomide Pharmion, as a monotherapy, for treatment for patients with multiple myeloma after failure of standard therapies.
THALOMID received FDA clearance in 1998, and Thalidomide Pharmion received TGA approval in 2003 for the acute treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence. Thalidomide Pharmion is not indicated as monotherapy for ENL treatment in the presence of moderate to severe neuritis.
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.
The Therapeutic Goods Administration is the regulatory body for therapeutic goods in Australia. It is a Division of the Australian Department of Health and Aging and is responsible for conducting assessment and monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard and that access to therapeutic advances is in a timely manner.
About Celgene International Sárl
Celgene International Sárl, located in Boudry, in the Cantone 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.
THALOMID® is a registered trademark of Celgene Corporation.
Thalidomide Pharmion® is a registered trademark of Celgene Corporation
This release contains forward-looking statements which are subject to 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 expressed or 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 other factors described in the Company's filings with the Securities and Exchange Commission such as our 10K, 10Q and 8K reports.
Source: Celgene International Sarl
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