ORLANDO, Fla., May 14, 2005 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM) today announced positive results from studies of VELCADE in lymphoma and lung cancer at the 41st Annual Meeting of the American Society of Clinical Oncology (ASCO) taking place this week in Orlando, Florida. Data for MLN2704, the Company's drug candidate for prostate cancer, were also presented. Results included:

• In relapsed patients with mantle cell lymphoma (MCL), interim results of a multicenter phase II study of single-agent VELCADE showed median survival had not been reached after 10.5 months of follow-up, and demonstrated an overall response rate of 42 percent;
• In non-small cell lung cancer (NSCLC), final data from the single-agent arm of the multicenter phase II trial of VELCADE with or without docetaxel showed a response rate and overall survival comparable to approved agents for use in second-line lung cancer; and
• In patients with late-stage, hormone-refractory prostate cancer, interim phase I/II results of MLN2704 showed four of six patients receiving a high dose achieved a reduction in prostate specific antigen, including two with a greater than 50 percent reduction.

"These data demonstrate the growth potential of VELCADE and the strength of the Company's development programs in several areas including non-Hodgkin's lymphoma," said David Schenkein, M.D., senior vice president, clinical research, Millennium. "The early mantle cell data is consistent with results from four previously presented trials and is particularly exciting considering that these were heavily pre-treated patients and the toxicities were predictable and manageable."

VELCADE is approved in the U.S. for the treatment of patients who have received at least one prior therapy. Millennium and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) continue to investigate VELCADE globally in phase I, II and III clinical trials in both hematologic and solid tumors, including front-line MM, non-Hodgkin's lymphoma and lung, prostate and ovarian cancers.

VELCADE® (bortezomib) for Injection in Relapsed MCL (ASCO Abstract 6563)

The second-stage interim analysis of the PINNACLE phase II study led by Richard Fisher, M.D., University of Rochester, and presented by Andre Goy, M.D., Hackensack University Medical Center, Hackensack, NJ, showed the median survival for patients had not been reached at 10.5 months of follow up. Preliminary results from 48 evaluable patients included:

• Overall response rate of 42 percent with a complete and unconfirmed complete response rate of eight percent;
• Median duration of response was 6.2 months and median time to progression was 4.3 months;
• Patients received 1.3 mg/m(2) of VELCADE for a median of 4.5 cycles; and
• Adverse events were similar to those observed in other clinical trials and toxicities were found to be predictable and manageable and included fatigue, peripheral neuropathy and gastrointestinal events.

Millennium was granted fast track status by the FDA for VELCADE in MCL in November 2004. In June, the Company will be presenting additional data from other lymphoma trials at the 9th International Conference on Malignant Lymphoma in Lugano, Switzerland.

VELCADE in Second-Line NSCLC (ASCO Abstract 7034)

Data from a multicenter phase II study, led by Joan Schiller, M.D., University of Wisconsin Comprehensive Cancer Center, and presented by Michael Fanucchi, M.D., Winship Cancer Institute, Emory University, Atlanta, GA, were reported. Investigator-assessed responses included:

Single agent results (n=75)

• Median survival of 7.4 months and one-year survival of 39 percent;
• Approximately eight percent achieved a partial response, and disease control rate (stable disease or better) was 29 percent; and
• Median time to progression of 1.5 months.

Combination with docetaxel results (n=80)

• Median survival of 7.8 months and one-year survival of 33 percent;
• Approximately nine percent achieved a partial response and disease control rate was 54 percent; and
• Median time to progression of 4 months.

Patients in the study received 1.5 mg/m(2) of VELCADE as a single agent biweekly or 1.3 mg/m(2) of VELCADE biweekly plus 75mg/m(2) of docetaxel on day one of every three weeks. Patients received a median of two cycles. Toxicities were manageable and adverse events were similar to those observed in other clinical trials of VELCADE such as gastrointestinal symptoms, fatigue and peripheral neuropathy.

Millennium and J&JPRD remain committed to further development and plan to commence randomized, phase II trials of VELCADE in combination with Tarceva (erlotinib) and Alimta (pemetrexed), two new therapies in the treatment of NSCLC. The companies also recently announced the initiation of the phase II PEAK trial in brochioloalveolar carcinoma.

MLN2704 in Late-stage Hormone Refractory Prostate Cancer (ASCO Abstract 4615)

Preliminary data from an ongoing multicenter, open label phase I/II clinical trial led by Howard Scher, M.D., Memorial Sloan-Kettering Cancer Center, and presented by Matthew Milowsky, M.D., Weill Medical College of Cornell University, were reported. Responses were evaluated based on a sustained 50 percent prostate specific antigen (PSA) decline and by measurable disease (RECIST criteria). Investigators reported the following results:

• Four of six patients receiving MLN2704 at 330mg/m(2) achieved a greater than 25 percent reduction in PSA, two of which achieved a greater than 50 percent reduction;
• In the study overall (n=29), three patients achieved a decrease of PSA greater than 50 percent that was sustained 10 weeks in one patient and greater than 31 weeks in another patient. Five additional patients achieved a decrease of PSA between 25 and 50 percent that was sustained between four and 13 weeks;
• Of the seven patients with measurable disease, four achieved stable disease by RECIST criteria; and
• Toxicities have been generally low-grade (Grade 1 and 2) and manageable, including neutropenia, neuropathy, fatigue and gastrointestinal symptoms; the only dose limiting toxicity was increased serum alanine transaminase.

"MLN2704 is a conjugated monoclonal antibody that shows activity in prostate cancer tumors in a novel way," said Howard Scher, M.D., Chief of Genitourinary Oncology at Memorial Sloan-Kettering Cancer Center in New York, and the study's lead investigator. "We are continuing with early phase I/II trials to assess the optimal dose and schedule of MLN2704."

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 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%). 14% 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® (bortezomib) for Injection 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 and Janssen-Cilag are 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 46 countries worldwide, including the U.S., European Union and a number of countries within Latin America and South-East Asia.

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 MLN2704

MLN2704 is composed of a deimmunized monoclonal antibody (MLN591) directed at prostate specific membrane antigen (PSMA) conjugated to the chemotherapeutic agent DM1. MLN2704 binds to PSMA, which is rapidly internalized into the cell delivering a lethal dose of chemotherapy directly to prostate cancer cells. Unlike the enzyme PSA which circulates in the blood, PSMA is a protein expressed on the cell surface of virtually all prostate cancer cells and its abundance on the cell surface increases as the disease progresses and becomes refractory to hormonal therapy. PSMA has little expression in normal tissues.

In April 2001, Millennium entered into an agreement with BZL Biologics, L.L.C., for the joint development and commercialization of antibody-based therapeutics targeting PSMA, including both chemotherapeutic agent conjugated and radio-labeled products. These products include MLN2704 and MLN591RL. Millennium currently has exclusive development and worldwide marketing rights to these products. To develop MLN2704, Millennium conjugates the chemotherapeutic agent DM1 -- licensed from ImmunoGen, Inc. -- to the MLN591 antibody, which targets PSMA. DM1 was developed by ImmunoGen specifically for antibody-directed delivery to tumor cells.

About Millennium

Millennium Pharmaceuticals, Inc., a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE, a novel cancer product, co-promotes INTEGRILIN® (eptifibide) 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.

This press release contains "forward-looking statements," including statements about the Company's growth, future operating results, discovery and development of products and strategic alliances. 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® (bortezomib) for Injection and INTEGRILIN® (eptifibide) 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: This release is available under the Media section on the Company's website at http://www.millennium.com.

ASCO Abstracts: 6563, 7034, 4615

CONTACT:
Theresa McNeely
media
+1-617-679-7405

Kyle Kuvalanka
investor
+1-617-761-4734
Both of Millennium Pharmaceuticals, Inc.