full release includes some data on the trial...
Millennium to Discuss Full Approval of VELCADE(R) (bortezomib) for Injection in Second-Line Multiple Myeloma
Monday March 28, 8:01 am ET
- Significant survival advantage and next steps for VELCADE are among highlights of presentation at Citigroup Smith Barney Healthcare Conference -
CAMBRIDGE, Mass., March 28 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) today announced that the Company will be focusing on the recent full approval of VELCADE in relapsed refractory multiple myeloma (MM) at the upcoming Citigroup Smith Barney Healthcare Conference. Management will discuss the significant survival advantage that was demonstrated in a phase III study comparing VELCADE to a standard therapy, the results of which led to the expanded label in the treatment of patients with MM who have received at least one prior therapy.
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The U.S. Food and Drug Administration (FDA) approved the Company's supplemental New Drug Application (sNDA) for VELCADE on March 25, 2005, less than two years after the initial accelerated approval for relapsed and refractory MM was granted. VELCADE is the only drug therapy that has demonstrated a significant survival advantage as compared to a standard therapy in relapsed MM. This indication doubles the number of U.S. patients who could potentially benefit from VELCADE to approximately 22,000.
"The new label recognizes the benefits of VELCADE in earlier lines of therapy for MM patients, and we believe ongoing studies will continue to build evidence for its potential use in the front line setting," said Mark Levin, chief executive officer, Millennium. "The approval further demonstrates the success of the Company's strategy to rapidly advance drugs from pipeline to market, and then expand the indications to benefit more patients."
Millennium management will present at 3:55 p.m. EST on Tuesday, March 29, 2005, from The Mayflower Hotel in Washington, DC. The event will be webcast live and will be archived for 30 days. It can be accessed by visiting the Investors section of the Company's website, millennium.com.
VELCADE is being co-developed by Millennium and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Millennium is responsible for commercialization of VELCADE in the U.S.; Ortho Biotech and Janssen-Cilag are responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical K.K. is responsible for Japan.
To date, approximately 12,000 patients have been treated with VELCADE. VELCADE is currently approved in more than 40 countries around the world, for treatment of multiple myeloma (MM) patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy.
About VELCADE® (bortezomib) for Injection
VELCADE is indicated for the treatment of multiple myeloma patients who have received at least one prior therapy. VELCADE is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol.
VELCADE is being co-developed by Millennium and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Millennium is responsible for commercialization of VELCADE in the U.S.; Ortho Biotech and Janssen-Cilag are responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical K.K. is responsible for Japan.
Risks associated with VELCADE therapy include new or worsening peripheral neuropathy, hypotension, cardiac disorders, gastrointestinal adverse events, thrombocytopenia and tumor lysis syndrome. Women of childbearing potential should avoid becoming pregnant while being treated with VELCADE.
In 331 patients who were treated with VELCADE 1.3 mg/m2 dose in the phase III APEX study, the most commonly reported adverse events were asthenic conditions (61%), diarrhea (57%), nausea (57%), constipation (42%), peripheral neuropathy (36%), vomiting (35%), pyrexia (35%), thrombocytopenia (35%), psychiatric disorders (35%) and anorexia and appetite decreased (34%). Fourteen percent of patients reported at least one episode of grade 4 toxicity; the most common grade 4 toxicities were thrombocytopenia (4%), neutropenia (2%) and hypercalcemia (2%). A total of 144 patients on VELCADE (44%) reported serious adverse events (SAEs) during the study. The most commonly reported SAEs were pyrexia (6%), diarrhea (5%), dyspnea and pneumonia (4%) and vomiting (3%).
For more information about VELCADE clinical trials, patients and physicians can contact the Millennium Medical Product Information Department at 1-866-VELCADE (1-866-835-2233).
About Millennium
Millennium Pharmaceuticals, Inc., a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE, a novel cancer product, co- promotes INTEGRILIN® (eptifibatide) Injection, a market-leading cardiovascular product and has a robust clinical development pipeline of product candidates. The Company's research, development and commercialization activities are focused in three therapeutic areas: oncology, cardiovascular and inflammation. By applying its knowledge of the human genome, its understanding of disease mechanisms and its industrialized drug discovery platform, Millennium is seeking to develop breakthrough products. |
