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Australia Recommends Approval of Thalidomide For Treatment of Relapsed and Refractory Multiple Myeloma, and Complications of Leprosy

WARREN, NJ -- August 19, 2003 -- Celgene Corporation (Nasdaq: CELG) announced today that the Australian Drug Evaluation Committee has recommended for approval Pharmion's thalidomide for the treatment of both patients with relapsed and refractory multiple myeloma (MM) and for the treatment of cutaneous manifestations of erythema nodosum leprosum (ENL), a severe and debilitating condition associated with leprosy. The TGA and Pharmion are working together to finalize the details for registration and labeling. Pharmion anticipates a product launch with the Pharmion Risk-Management Program (PRMP) within six to eight weeks.

The milestone decision in Australia will represent the first approval worldwide for thalidomide as a therapy for relapsed and refractory multiple myeloma. The U.S. Food and Drug Administration approved thalidomide for the treatment of cutaneous manifestations of erythema nodosum leprosum (ENL) in July 1998.

On November 19, 2001, Celgene granted Pharmion exclusive licenses for Europe and certain other territories outside of the United States to its intellectual property covering thalidomide and S.T.E.P.S.(R) (System for Thalidomide Education and Prescribing Safety) as well as preclinical and clinical data necessary to support international regulatory filings for thalidomide. The S.T.E.P.S.(R) system was developed in cooperation with the FDA as a method of using thalidomide by administering thalidomide while avoiding exposure to a developing fetus which includes restrictive distribution program for the prescribing and dispensing of THALOMID(R) (Thalidomide). Celgene has multiple issued patents in the Orange book with expiration dates of 2018 and 2020, that cover the S.T.E.P.S.(R) program, a mandated part of the THALOMID(R) (Thalidomide) label.

Celgene presently holds a minority investment in Pharmion, as well as an exclusive option to purchase Penn T, the branch of Penn Pharmaceutical Services Limited that manufactures thalidomide. This option, if exercised, would enable Celgene to receive both a 36 percent royalty (less cost of goods sold) on their thalidomide sales and to manage the manufacturing of thalidomide as a wholly owned subsidiary of Celgene. Furthermore, Celgene has retained the rights for thalidomide in North America, China, Japan, Korea, and Taiwan.

Sol Barer, Ph.D., President and Chief Operating Officer at Celgene commented, "This will be the first approval for a drug in multiple myeloma in Australia in many years. The approval of thalidomide in Australia will offer a meaningful option for myeloma patients and their families. Australia will be the first country to approve thalidomide for this deadly disease, and we look forward to similar outcomes in a number of other countries, where pivotal clinical trials are underway."

The recommendation for approval of thalidomide in Australia reflects a real recognition of the critical need for new treatment options for multiple myeloma (MM). Multiple myeloma is the second most common cancer of the blood, representing approximately one percent of all cancers and two percent of all cancer deaths with a worldwide prevalence of approximately 200,000 cases. In the year 2002, there were an estimated 74,000 new cases of multiple myeloma worldwide. The estimated number of deaths from multiple myeloma in 2002 was 57,370 worldwide.

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 is unknown.

About ENL:

ENL is a severe and painful complication of leprosy. Thalidomide has been used to treat ENL patients in the U.S. for more than twenty years through a U.S. Public Health Service compassionate use program. The drug was designated as the treatment of choice for ENL by the World Health Organization in 1994.


SOURCE: Celgene Corporation

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