CAMBRIDGE, Mass., Nov. 2 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. today provided clinical development updates at its annual Analyst Day in New York City. Millennium reported key clinical advancements in the development of VELCADE(R) (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.
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“Today’s oncology and inflammation advancements are the result of our strengths in delivering high-value molecules through a rigorous proof-of- concept process, a proactive regulatory approach, and aggressive commercial strategies,” said Deborah Dunsire, M.D., president and chief executive officer of Millennium. “By realigning resources to focus on the most promising opportunities and maintaining a strong fiscal discipline, Millennium continues its drive toward non-GAAP profitability in 2006 and growth beyond.”
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.
The webcast of the Analyst Day event will be archived for 30 days and may be accessed by visiting the Investors section of the Company’s website, http://www.millennium.com.
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, including the U.S., the countries of the European Union and a number of countries within Latin America and South-East Asia. VELCADE is also approved in the European Union as a second-line treatment. It is indicated as a monotherapy for use in patients with progressive multiple myeloma who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplantation.
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.
Editor’s Note: This release is available on the Media section of the Millennium website at http://www.millennium.com.
This press release contains “forward-looking statements,” including statements about the Company’s growth, strategic alliances, discovery 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.
Contacts:
Theresa McNeely (media) Kyle Kuvalanka (investors)
(617) 679-7405 (617) 761-4734
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CONTACT: Theresa McNeely, +1-617-679-7405, or Kyle Kuvalanka,+1-617-761-4734, both of Millennium Pharmaceuticals, Inc.
Web site: http://www.millennium.com//
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