Millennium Pharmaceuticals, Inc. (MLNM) Release: VELCADE(R) For Injection Single-Agent And Combination Studies Show Positive Outcomes In A Broad Range Of Multiple Myeloma Patients

ATLANTA, Dec. 12 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) today announced positive results in a broad range of multiple myeloma populations exploring the use of VELCADE alone and in combination with other therapies. These studies show, despite poor prognostic factors, overall response rates up to 78 percent in relapsed and refractory multiple myeloma patients, a population in which the landmark phase III APEX trial has already demonstrated a median 30-month survival benefit for VELCADE as a single agent. The data were presented at the 47th Annual Meeting of the American Society of Hematology (ASH) being held December 10-13, 2005 in Atlanta, GA.

"The findings from these studies are exciting, most notably the high response rate and favorable safety profile of VELCADE in patients with renal failure, a condition which effects up to 50 percent of all multiple myeloma patients experience at some stage of their disease(1)," said David Schenkein, M.D., senior vice president, clinical development, Millennium. "Other studies show mounting evidence of VELCADE activity in patients with other poor prognostic factors such as chromosome 13 deletion."

VELCADE Multi-Center Retrospective Review of Relapsed Patients with Renal Failure (abstract #2550)

A multi-center, retrospective review of the safety and efficacy of VELCADE based therapy in relapsed multiple myeloma patients with renal failure requiring hemodialysis was conducted by Asher Alban Chanan-Khan, M.D., of the Roswell Park Cancer Institute in Buffalo. Data from 24 evaluable patients showed:

* Overall response rate of 78% was achieved with single-agent VELCADE and various VELCADE based combinations, with 33% of patients achieving a complete or near-complete response with a median of 7.5 cycles * Three patients achieved a complete response and did not require dialysis * VELCADE at full dose was generally well tolerated with manageable side effects; serious adverse events were rare, and did not appear to be increased compared to patients with normal renal function

"Patients with relapsed, refractory multiple myeloma often present with renal failure which can greatly impact their ability to tolerate treatment," said Dr. Chanan-Khan. "These results suggest that VELCADE may enable us to overcome this challenge and offer a much needed treatment option for these patients."

VELCADE Single-Agent in Patients with Chromosome 13 Deletion (abstract #509)

A retrospective analysis, conducted by Johannes Drach, M.D., at the Medical University of Vienna in Austria, evaluated the efficacy of VELCADE with poor prognostic factors, in particular chromosomal abnormalities, including chromosome 13 deletion. The objectives of the study were to assess response rate, time to treatment failure (TTF/TTP), and overall survival. Patients had received a median of three prior therapies. Results from 51 evaluable patients showed:

* Overall response rates, including complete and near-complete response rates, and duration of response were independent of chromosome 13 status * In patients with the chromosome 13 deletion, overall response rate was 50% with 23% of patients achieving a complete response and a 10.4-month duration of response * Median overall survival was 15 months and also independent of chromosome 13 status * Response rate and overall survival were also independent of other poor prognostic factors including 14q abnormality and Beta-2 microglobulin level

"The important observation is that with VELCADE treatment, we do not see a difference in response rate or duration of response for patients with and without a 13q deletion," said Dr. Drach. "This is different from the experience with chemotherapy and even transplantation."

VELCADE with Lenalidomide in Relapsed and Refractory Patients (abstract #365)

An ongoing, phase I trial conducted by Paul Richardson, M.D., of the Dana- Farber Cancer Institute in Boston evaluated the maximum-tolerated dose of VELCADE and lenalidomide in patients with relapsed and/or refractory multiple myeloma. Data from 21 evaluable patients showed:

* Overall response rate (includes complete, partial and minor responses) of 67% -- Two patients achieved complete or near-complete responses -- Nine achieved partial responses * Patients were heavily pretreated with a median of five prior therapies, including: VELCADE (50%), thalidomide (80%), lenalidomide (10%) and stem cell transplant (40%) * Median of seven cycles were completed; maximum-tolerated dose has not yet been reached * Most common adverse events for the combination were thrombocytopenia and neutropenia, but were very manageable

About Multiple Myeloma (MM) MM is the second most common hematologic malignancy and although the disease is predominantly a cancer of the elderly (the average age of onset is 65 to 70 years of age), recent statistics indicate both increasing incidence and younger age of onset. In the U.S., more than 45,000 to 50,000 individuals have MM and over 15,000 new cases are diagnosed each year. Worldwide there are approximately 74,000 new cases and over 45,000 deaths annually(2).


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

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® (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, 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

Contacts: Theresa McNeely (media) Kyle Kuvalanka (investors) (617) 679-7405 (617) 761-4734 (1) Pandit SR, Current Treatment Options in Oncology, 2003 Jun; 4(3):239-46 (2) American Cancer Society, Overview: Multiple Myeloma, 2005,

Source: Millennium Pharmaceuticals, Inc.

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