Velcade

-- High single-agent and combination therapy response rates reported --

ATLANTA, Dec. 12 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. today announced the results from phase II studies evaluating the efficacy and safety of VELCADE in patients with aggressive and indolent subtypes of non-Hodgkin's lymphoma (NHL). The results show high response rates, favorable safety and dosing with VELCADE as a single-agent and in combination therapy. These findings were reported in independent oral presentations at the 47th Annual Meeting of the American Society of Hematology (ASH) being held December 10-13, 2005, in Atlanta, GA.

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"The efficacy and safety results presented here on VELCADE alone and in combination with other standard therapies, such as rituximab, show the potential of VELCADE to treat a broad range of lymphomas, including mantle cell and follicular lymphomas," said David Schenkein, M.D., senior vice president, clinical development, Millennium. "These findings have led Millennium and co-developer Johnson & Johnson Pharmaceutical Research & Development, to pursue additional clinical studies in non-Hodgkin's lymphoma, including a phase III trial of once-weekly VELCADE plus rituximab versus rituximab alone in follicular lymphoma, expected to begin in the second half of 2006."

VELCADE Combination with Rituximab (abstract #17)

The randomized, multi-center phase II study, led by Andre Goy, M.D., of Hackensack University Medical Center in Hackensack, and Sven de Vos, M.D., Ph.D., of UCLA Medical Center in Los Angeles, evaluated weekly (1.6mg/m2) and twice-weekly (1.3mg/m2) dosing of VELCADE in combination with the standard- weekly dose of rituximab in patients with relapsed and refractory indolent B- cell lymphomas. The more convenient weekly regimen showed a similar response rate to the twice-weekly arm with an improved safety profile. Results from the 74 evaluable patients (39 in the weekly arm and 35 in the twice-weekly arm) included:

"These results are encouraging with similar response rates in both arms," said Dr. de Vos. "The weekly schedule for VELCADE and rituximab appears promising with more convenience to patients, while maintaining efficacy and safety. These data support the decision to initiate a phase III study in follicular lymphoma in the near future."

VELCADE Combination with CHOP Plus Rituximab (abstract #491)

Results from a phase I/II study of VELCADE in combination with standard cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) plus rituximab for the treatment of previously untreated patients with diffuse large B-cell (DLBCL) and mantle cell lymphomas (MCL) were presented by John P. Leonard, M.D., of Weill Medical College of Cornell University/New York Presbyterian Hospital in New York. With a median follow-up of 13 months, data from the phase I cohort of 20 patients (16 DLBCL, four MCL) showed:

Results from a phase II study of single-agent VELCADE in patients with Waldenstrom's macroglobulinemia, a form of indolent lymphoma, were presented by Steven Treon, M.D., Ph.D., of Dana Farber Cancer Institute in Boston. Results from 27 evaluable patients included:

Non-Hodgkin's lymphoma (NHL) is the most common hematological cancer and the fifth leading cause of cancer death in the U.S. There are approximately 56,400 new cases diagnosed per year, it is responsible for 19,200 deaths annually and is the second fastest growing form of cancer in the U.S.(1) The prevalence of NHL is approximately 400,000, including 77,000 patients with follicular lymphoma and approximately 10,000 with mantle cell lymphoma.(2),(3) According to the American Cancer Society, the incidence of NHL has more than doubled since the 1970s. The average age of diagnosis is between 55 and 60.

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 observed throughout therapy, 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, 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. 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/.

This press release contains "forward-looking statements," including statements about the Company's growth and development of products. Various important risks may cause the Company's actual results to differ materially from the results indicated by these forward-looking statements, including: adverse results in its drug discovery and clinical development programs; failure to obtain patent protection for its discoveries; commercial limitations imposed by patents owned or controlled by third parties; the Company's dependence upon strategic alliance partners to develop and commercialize products and services based on its work; difficulties or delays in obtaining regulatory approvals to market products and services resulting from its development efforts; product withdrawals; competitive factors; difficulties or delays in manufacturing the Company's products; government and third party reimbursement rates; the commercial success of VELCADE and INTEGRILIN(R) (eptifibatide) Injection; achieving revenue consistent with internal forecasts; and the requirement for substantial funding to conduct research and development and to expand commercialization activities. For a further list and description of the risks and uncertainties the Company faces, see the reports it has filed with the Securities and Exchange Commission. The Company disclaims any intention or obligation to update or revise any forward- looking statements, whether as a result of new information, future events or otherwise.

Editor's Note: 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.

Also, this release is available under the Media section on the Company's website at http://www.millennium.com/.

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

Web site: http://www.millennium.com/

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