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VELCADE (Bortezomib) receives European marketing authorisation

Brussels, Belgium, {27 April 2004} Ortho Biotech, the biopharmaceutical division of Janssen-Cilag, today announced that the European Commission has issued a positive decision for VELCADE, a new treatment for multiple myeloma, a form of blood cancer. The novel drug is indicated to treat multiple myeloma patients who have received at least two prior therapies and demonstrated disease progression on their last therapy.

VELCADE is a completely new approach to treating multiple myeloma that acts on a unique target in cells called the proteasome.

Multiple myeloma is the second most common blood cancer, representing approximately one percent of all cancers and two percent of all cancer deaths. Worldwide in 2000, there were 73,943 cases of multiple myeloma and 57,370 deaths. In Europe there were approximately 19,000 cases in 2000 and just under 15,000 deaths (1). Only 30 percent of multiple myeloma patients survive longer than five years (2).

"The approval of VELCADE by the European Agency for the Evaluation of Medicinal Products (EMEA) represents a breakthrough in our continued battle against multiple myeloma" said Professor Mario Boccadoro, Professor of Hematology, Director of the Section of Hematology, University of Torino, Italy. "With its new and unique mechanism of action, VELCADE represents a new treatment option for patients".

Clinical results from a phase II study have shown that VELCADE can slow, reverse or halt progression of disease in patients who failed on two or more treatments, potentially helping patients live longer. In a study of 202 patients with relapsed and refractory multiple myeloma and who progressed after initial treatments, 35% responded to VELCADE and 10% had a complete remission. This pivotal study was the basis for an accelerated review of VELCADE by U.S. Food and Drug Administration (FDA) and approval within four months of the New Drug Application submission on 13 May 2003.

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Contact: Eva Reynolds
eva_reynolds@uk.bm.com
44-20-7831-6262
Burson-Marsteller
28-Apr-2004


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