FDA approval of THALOMID® for Myeloma Patients

Once Controversial Drug Transformed into a "Standard of Care"

that Extends and Improves the Quality of Life for Myeloma Patients

May 25, 2006—The International Myeloma Foundation today applauded the Food and Drug Administration's formal approval of thalidomide, marketed under the brand name THALOMID® by the Celgene Corporation, for the treatment of myeloma. Myeloma, also called multiple myeloma, is an incurable but treatable cancer in the bone marrow affecting production of red cells, white cells and stem cells. Thalidomide was associated with an epidemic of birth defects in the 1950's and 60's when it was prescribed as a sedative for pregnant women across Europe, but the drug was later discovered to have powerful anti-cancer properties and has been transformed into the most widely prescribed treatment for myeloma today.

"THALOMID means that despite having myeloma, I have been able to continue my work as a wildlife filmmaker and to actively continue working to protect wild dolphins," said Hardy Jones, a television journalist-turned-conservationist who has been making documentaries about marine mammals for more than 25 years and co-founded the oceanic conservation group BlueVoice.org. His program about his life's work with dolphins aired on PBS earlier this month. "When I was diagnosed with myeloma, I was afraid I'd have to curtail many activities and stop underwater filming and international travel, but because of my treatment with THALOMID, I'm still producing wildlife documentaries and maintaining my Internet-based advocacy work."

Until the current FDA action, thalidomide was formally approved in the United States only for a side effect of leprosy. However its use in myeloma has been supported by the authoritative National Comprehensive Cancer Network Clinical Practice Guidelines and by numerous clinical trials in newly diagnosed patients as well as those who have relapsed following other treatments. FDA approval means physicians can now prescribe THALOMID for myeloma knowing that it has undergone the FDA's rigorous scientific and safety review process, which will help re-assure patients and facilitate coverage by insurers.

Susie Novis, president of the International Myeloma Foundation, commented: "While we are encouraged by several promising new treatments including VELCADE® and REVLIMID®, myeloma patients rely on multiple regimens so that a new treatment will be available when an old one fails. THALOMID is clinically proven and remains an essential component of myeloma treatment."

Because of thalidomide's history with birth defects, it can only be distributed to patients using Celgene's patented, mandatory program called S.T.E.P.S.® to help ensure it will not be used by women during pregnancy.

"I appreciate the full potential of thalidomide as a valuable treatment for multiple myeloma, and prescribe it to my myeloma patients, even though I know personally the costs of misusing the drug since my own mother took it for morning sickness when she was pregnant with me," said Ralph Naumann, M.D. Ph.D., Dresden University Hospital Germany. "Thalidomide is not a bad drug, it's just a drug that was badly used, and for the many myeloma patients today who are benefiting from thalidomide, that's a crucial distinction."

The FDA approved Thalomid for use in newly diagnosed myeloma patients. Although thalidomide was developed as a powerful sedative, in 1994 doctors began looking at its ability to block growth of blood vessels in malignant tumors, and it was first tested in multiple myeloma in 1997. Within a year thalidomide became recognized as the most promising new agent for multiple myeloma at the time, and it remains an essential part of both the treatment regimen and research into the underlying mechanisms of blood and related cancers.