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European Medicines Agency Recommends Approval of Lenalidomide as a Treatment for Multiple Myeloma

SUMMIT, N.J., March 23 /PRNewswire-FirstCall/ -- Celgene Corporation (NASDAQ:CELG) announced today that its innovative oral cancer drug Revlimid (lenalidomide) has received a positive opinion from the European Medicines Agency (EMEA) for use in combination with dexamethasone as a treatment for patients with multiple myeloma who have received at least one prior therapy. The EMEA's Committee for Medicinal Products for Human Use (CHMP), which reviews applications for all 27 Member States in the European Union (EU) as well as Norway and Iceland, has recommended approval for Revlimid. The CHMP's positive opinion will be forwarded to the European Commission that generally follows the recommendation of the CHMP and issues final marketing approval within two to three months.

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

"The CHMP recommendation is an especially important and positive milestone for Celgene. We are fully committed to deliver Revlimid to patients in need throughout the EU," said Aart Brouwer, President of Celgene International. "We're optimistic that Revlimid will have broad support based on its value to patients and to the healthcare system. Upon approval we are prepared to initiate next steps for pricing, reimbursement and distribution plans for all EU member states."

The positive opinion from the CHMP 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.

"The positive opinion of Revlimid from the CHMP is an important step forward towards providing a new oral therapeutic option for this particular group of patients with multiple myeloma," said Graham Burton, M.D., SVP, Global Regulatory Affairs and Pharmacovigilance for Celgene. "We are committed to continue our work with the European authorities to bring Revlimid to patients in need as quickly as possible."

Upon the European Commission's approval for Revlimid as an oral combination treatment with dexamethasone for multiple myeloma patients who have received at least one prior therapy, Celgene Europe will initiate next steps for marketing, distribution, pricing and reimbursement approvals for all EU member states.

Revlimid has obtained Orphan Drug designation in the EU, US and Australia for treatment of Multiple Myeloma and is already approved for use as a treatment in combination with dexamethasone for patients previously treated with multiple myeloma by the U.S. Food and Drug Administration (FDA). Revlimid is also approved 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 by the FDA.

Source: Celgene

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