Oral Cancer Drug REVLIMID Receives Swissmedic Approval In Switzerland For Treatment Of Multiple Myeloma

Boudry, Switzerland - Celgene International Sàrl announced recently that its innovative oral cancer drug REVLIMID (lenalidomide) has been granted approval by the Swiss Agency for Therapeutic Products (Swissmedic) for use in combination with dexamethasone as a treatment for patients with multiple myeloma who have received at least one prior therapy. This approval represents the first regulatory approval for Celgene in Switzerland, and REVLIMID represents the first breakthrough oral therapy in Switzerland for multiple myeloma patients in more than forty years.

Multiple myeloma is the second most commonly diagnosed blood cancer. According to the International Myeloma Foundation, there are an estimated 750,000 people with multiple myeloma worldwide. There are more than 85,000 men and women in Europe currently undergoing treatment for multiple myeloma, and 25,000 people are expected to die from this blood cancer in 2007.

"The opportunity to offer REVLIMID as an oral therapy to our patients, gives a new structure to the way multiple myeloma is treated and means important progress", says Dr. Taverna, Head of Oncology, at the hospital of Münsterlingen. "For us as treating physicians it is of high importance that companies such as Celgene support clinical research. For the treatment of patients with multiple myeloma we have now two multinational, randomized trials, demonstrating the superior efficacy of REVLIMID in combination with Dexamethasone, compared to Dexamethasone alone."

"The Swiss approval of REVLIMID is an especially important and positive milestone for Celgene, as well as an important step toward achieving our global mission of making innovative oral therapies available to patients with significant unmet medical needs worldwide," said Aart Brouwer, President of Celgene International. We are working diligently with Swissmedic to determine next steps for pricing, reimbursement and distribution so that REVLIMID is available for eligible patients in Switzerland as quickly as possible."

The Marketing Authorization Application (MAA) for REVLIMID was based upon the safety and efficacy results of two large, randomized 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 that have received at least one prior therapy.

"REVLIMID represents a significant advancement in the treatment of multiple myeloma and we are fully committed to swiftly bringing this new oral therapeutic option to patients in need across Europe," said Graham Burton, M.D., SVP, Global Regulatory Affairs and Pharmacovigilance for Celgene. "We remain committed to the broad and global clinical development of our investigational therapies being studied in blood and solid tumor cancers, and we are grateful that our collaborative efforts have resulted in this approval of REVLIMID."

REVLIMID has obtained Orphan Drug designation in the EU, US and Australia for treatment of multiple myeloma. REVLIMID is approved for use as an oral treatment in combination with dexamethasone by the European Commission, following the recommendation from the European Medicines Agency (EMEA). REVLIMID is currently approved in the US by the U.S. Food and Drug Administration (FDA) for multiple myeloma patients who have received at least one prior therapy. REVLIMID is also approved in the US, by the FDA, for treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

SOURCE: About Celgene International Sárl