European Commission Grants Marketing Authorization to Millennium for VELCADE(R) (Bortezomib)
Tuesday April 27, 12:15 pm ET
First new treatment to be approved in the European Union for patients with relapsed and refractory multiple myeloma in more than 10 years to be marketed by Ortho Biotech
CAMBRIDGE, Mass., April 27 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) today announced that the European Commission has granted marketing authorization for VELCADE for the treatment of patients with multiple myeloma who have received at least two prior therapies and have demonstrated disease progression on their last therapy. The Marketing Authorization Application for VELCADE was submitted to the European Medicines Evaluation Agency (EMEA) in January 2003 and accepted for review in February 2003.
(Logo: newscom.com )
Under this authorization, a single license is granted for marketing VELCADE in the 15 member states of the European Union, plus Norway and Iceland. On May 1, 2004, VELCADE will also be approved when the 10 accession member countries officially join the European union.
"The European approval of VELCADE represents another significant step toward the Company's global mission of developing and delivering to the marketplace breakthrough medicines that make an important difference in patients' lives," said Mark Levin, chief executive officer and chairperson of Millennium. "Through much hard work and collaboration with investigators, advocates, the European regulatory authorities and our research and development collaborator, Johnson & Johnson Pharmaceutical Research and Development, Millennium will be able to expeditiously bring VELCADE to patients in need across Europe."
Under the terms of the co-development and commercialization agreement for VELCADE, Ortho Biotech and its affiliate, Janssen-Cilag, divisions of Johnson & Johnson, will commercialize VELCADE outside of the U.S., including Europe. Millennium will receive royalties from Ortho Biotech and its affiliate Janssen-Cilag on sales outside the U.S.
"The approval of VELCADE by the European Commission represents an important step forward in the struggle against multiple myeloma," said Martine George, M.D., vice president, global clinical research and development for Johnson & Johnson Pharmaceutical Research and Development, L.L.C. "With its new and unique mechanism of action, VELCADE is different from traditional therapies and represents a significant new treatment option for patients."
VELCADE was approved in the United States in May 2003 and is marketed by Millennium in the U.S. for patients with multiple myeloma who have received at least two prior therapies and have demonstrated disease progression on the last therapy. Millennium and Johnson & Johnson Pharmaceutical Research and Development continue to investigate the full potential of VELCADE in both hematologic and solid tumors and in 2004 will have approximately 80 ongoing or planned clinical trials.
About VELCADE® (bortezomib) for Injection
VELCADE is approved for the treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. The effectiveness of VELCADE is based on response rates. There are no controlled trials demonstrating a clinical benefit, such as improvement in survival. VELCADE is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol.
VELCADE is being co-developed by Millennium Pharmaceuticals, Inc. and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Millennium is responsible for commercialization of VELCADE in the U.S. Ortho Biotech Products L.P. and the Janssen-Cilag group of companies will be responsible for commercialization in the EU and the rest of the world. Janssen Pharmaceutical K.K. will be responsible for Japan.
Risks associated with VELCADE therapy include new or worsening peripheral neuropathy, orthostatic hypotension, congestive heart failure, gastrointestinal adverse events, thrombocytopenia, and tumor lysis syndrome. Women of childbearing potential should avoid becoming pregnant while being treated with VELCADE.
In 228 patients who were treated with VELCADE® (bortezomib) 1.3 mg/m2/dose in phase II studies, the most commonly reported adverse events were asthenic conditions (65%), nausea (64%), diarrhea (51%), decreased appetite including anorexia (43%), constipation (43%), thrombocytopenia (43%), peripheral neuropathy (37%), pyrexia (36%), vomiting (36%), and anemia (32%). Fourteen percent of patients experienced at least one episode of Grade 4 toxicity, with the most common toxicities being thrombocytopenia (3%) and neutropenia (3%). A total of 113 (50%) of the 228 patients experienced Serious Adverse Events (SAEs) during studies. The most commonly reported SAEs included pyrexia (7%), pneumonia (7%), diarrhea (6%), vomiting (5%), dehydration (5%), and nausea (4%).
For more information about VELCADE clinical trials, patients and physicians can contact the Millennium Medical Product Information Department at 1-(866)-VELCADE. |
