Millennium announces clinical updates to analysts

From the Millennium corporate website at www.millennium.com

Millennium Pharmaceuticals, Inc. today provided clinical development updates at its annual Analyst Day. Millennium reported key clinical advancements in the development of VELCADE® (bortezomib) for Injection, its market-leading drug in relapsed multiple myeloma. These updates included the use of VELCADE in front line multiple myeloma, mantle cell and follicular lymphoma, non-small cell lung cancer, and key advances with other molecules. The Company also provided further details regarding its refined strategy to shift resources toward the inflammation and oncology development pipeline as well as commercial efforts in oncology.

Oncology Clinical Updates

Robert Tepper, M.D., president of research and development of Millennium, presented details of the Company's product pipeline which includes eight molecules in the clinic; four of which were developed by Millennium scientists.

Non-Hodgkin's Lymphoma

The Company announced today its intention to file a supplemental New Drug Application (sNDA) for VELCADE in mantle cell lymphoma in the second half of 2006. The Company, together with co-development partner, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), recently completed a phase II study of VELCADE as a single-agent in mantle cell lymphoma patients. Analysis of the data is currently underway, with final data anticipated in the first half of 2006.

Management also announced completed enrollment of 81 patients in a phase II study of VELCADE in relapsed follicular lymphoma, a type of Non-Hodgkin's lymphoma. The trial compared rituximab alone and in combination with VELCADE. Updated data will be presented at the American Society of Hematology meeting in December of this year. Planning for a phase III study of VELCADE in relapsed follicular lymphoma is underway with a potential start date in the second half of 2006.

Non-Small Cell Lung Cancer

Dr. Tepper presented interim survival data in non-small cell lung cancer from a phase II study of VELCADE as a front line treatment. The analysis, conducted by the Southwest Oncology Group, found that VELCADE in combination with gemcitabine and carboplatin, showed a median five-month progression-free survival and a median 11 month overall survival. Based on these and other results, the Company and J&JPRD are exploring clinical rationale, trial design and funding options for possible next steps.

Second Generation Proteasome Inhibitors

Dr. Tepper unveiled details of the Company's second-generation proteasome inhibitor platform which is a large, ongoing initiative aimed at enhancing safety and efficacy, exploring new boronates and other new chemotypes and developing novel chemistry upstream in the pathway. The Company plans to advance a second-generation proteasome inhibitor development candidate by the end of 2006.

Inflammation Clinical Update

The Company anticipates entering the oral, selective IKK inhibitor, MLN0415, into the clinic next year. This small molecule would inhibit IKK beta similar to VELCADE, by inhibiting NFkB. Preclinical data suggest that this molecule has activity across a variety of diseases including rheumatoid arthritis, multiple sclerosis, and chronic obstructive pulmonary disease. The Company's initial phase I study is expected to begin in the second half of 2006. This molecule is part of the sanofi-aventis development and commercialization collaboration.

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%).

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).