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Millennium Pharmaceuticals, Inc. (Cambridge, Massachusetts) Release: New Data On VELCADE(R) (Bortezomib) For Injection To Be Presented At Upcoming American Society of Hematology Meeting

Published: Dec 06, 2005

CAMBRIDGE, Mass., Dec. 6 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. today announced that data from studies of VELCADE will be featured at the 47th Annual Meeting of the American Society of Hematology in Atlanta, GA., December 10-13, 2005.

(Logo: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO )

Highlights from clinical studies of VELCADE that will be presented include:

Multiple Myeloma * Updated survival and safety data from the APEX trial -- Single-agent survival rates versus high-dose dexamethasone (abstract #2547) -- Frequency, characteristics and reversibility of peripheral neuropathy (abstract #3336) * Single-agent or combination therapy in the front-line setting -- Combination with melphalan and prednisone (abstract #786) -- Single-agent and in combination with dexamethasone (abstract #783) -- Combination with thalidomide and dexamethasone followed by autologous stem cell transplant (abstract #784) * VELCADE safety and efficacy data in difficult-to-treat populations -- VELCADE based combination therapies in relapsed patients with renal failure requiring dialysis (abstract #2250) -- VELCADE based combination therapies in patients with chromosome 13 deletion (abstract #509) Across Lymphomas * VELCADE activity in studies in a variety of lymphomas -- Combination with rituximab in indolent non-Hodgkin's lymphoma (abstract #7) -- Combination with CHOP plus rituximab in B-cell and mantle cell lymphoma (abstract #491) -- Single-agent in Waldenstrom's Macroglobulinemia, a B-cell malignancy (abstract #490)

Abstracts can be accessed on the ASH website at http://www.hematology.org and were published in the November 16, 2005 issue of BLOOD, the journal of the American Society of Hematology.

About VELCADE

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 should be administered under the supervision of a physician experienced in the use of antineoplastic therapy.

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 in a phase III 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%), anorexia and appetite decreased (34%), parasthesia (27%), dysesthesia (27%), anemia and headache (26%), and cough (21%). 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%).

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.; Janssen-Cilag is responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical K.K. is responsible for commercialization in Japan. VELCADE is approved in more than 60 countries worldwide, including the U.S., the countries of the European Union and a number of countries within Latin America and South-East Asia. VELCADE is also approved in the European Union as a second-line treatment.

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, and has a robust clinical development pipeline of product candidates. The Company's research, development and commercialization activities are focused in two therapeutic areas: oncology 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. The Company's website is http://www.millennium.com.

Editor's Note: This release is available on the Media section of the Millennium website at http://www.millennium.com.

Contacts:

Theresa McNeely (media) Kyle Kuvalanka (investors) (617) 679-7405 (617) 761-4734

Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGOAP Archive: http://photoarchive.ap.orgPRN Photo Desk photodesk@prnewswire.comMillennium Pharmaceuticals, Inc.

CONTACT: Theresa McNeely, +1-617-679-7405, or Kyle Kuvalanka,+1-617-761-4734, both of Millennium Pharmaceuticals, Inc.

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