MLNM Millennium Pharmaceuticals (MM)

-- Trial results of combination therapy VELCADE, melphalan and prednisone reported a 32 percent complete remission rate with 85 percent of patients alive at three years -- CAMBRIDGE, Mass., March 13 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (NASDAQ:MLNM) today announced the publication of updated results of the Phase I/II clinical trial of the combination therapy VELCADE, melphalan and prednisone (VcMP) in newly diagnosed multiple myeloma patients, who were ineligible for stem cell transplantation. Results of this study included one of the highest reported complete remission (CR) rates, which is an important indicator for long-term survival, and the highest three- year survival rate reported in the non-transplant setting. These results provided the basis for the Phase III VISTA trial. The Company submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) in December 2007 for VELCADE expansion into newly diagnosed multiple myeloma. The FDA decision date for the sNDA is scheduled for June 20, 2008. The Company's co-development partner, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) also has filed a corresponding application with the European Medicines Evaluation Agency. (Logo: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO ) "These results support the strong relationship between high rates of durable complete remissions with long-term survival in patients with newly diagnosed multiple myeloma," said Nancy Simonian, M.D., Chief Medical Officer, Millennium. "We are confident that VELCADE will be a key component of the standard of care in this patient setting." The study was pre-published online in the journal, Haematologica. Data from the 60 patient Phase I/II trial conducted by the PETHEMA Foundation in Spain were evaluated by the stringent European Group for Blood and Marrow Transplantation (EBMT) criteria and results are as follows: -- Results showed an immunofixation-negative CR rate of 32 percent and an overall response rate (ORR) of 89 percent with VcMP. -- The overall survival rate at 38 months was 85 percent with VcMP compared to the 38 percent historical control with melphalan and prednisone (MP) (p/= Grade 4 toxicity, most commonly thrombocytopenia (5%) and neutropenia (3%). A total of 50% of patients experienced serious adverse events (SAEs) during the studies. The most commonly reported SAEs included pneumonia (7%), pyrexia (6%), diarrhea (5%), vomiting (4%), and nausea, dehydration, dyspnea and thrombocytopenia (each 3%). Adverse events thought by the investigator to be drug-related and leading to discontinuation occurred in 22% of patients. The reasons for discontinuation included peripheral neuropathy (8%), asthenic conditions (3%) and thrombocytopenia and diarrhea (each 2%). In total, 2% of the patients died and the cause of death was considered by the investigator to be possibly related to study drug: including reports of cardiac arrest, congestive heart failure, respiratory failure, renal failure, pneumonia and sepsis. This integrated analysis does not include the Phase III, VELCADE plus DOXIL study. 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. Millennium's research, development and commercialization activities are focused in two therapeutic areas: oncology and inflammation. By applying its knowledge of the human genome, understanding of disease mechanisms and industrialized drug discovery platform, Millennium is developing an exciting pipeline of innovative product candidates. Millennium'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. Editors' Note: This press release is also available under the Media section of the Company's website at: http://www.millennium.com/ Contacts: Jennifer Snyder (media) Kyle Kuvalanka (investors) (617) 444-1439 (617) 761-4734 http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO http://photoarchive.ap.org/ DATASOURCE: Millennium Pharmaceuticals, Inc. CONTACT: Media: Jennifer Snyder, +1-617-444-1439; Investors: Kyle Kuvalanka, +1-617-761-4734, both for Millennium Pharmaceuticals, Inc. Web site: http://www.millennium.com/ Company News On-Call: http://www.prnewswire.com/comp/114562.html

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