CAMBRIDGE, Mass., March 9 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) today announced the Company will receive a $10 million payment from Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) based on sales milestones reached for VELCADE® (bortezomib) for Injection in territories outside the U.S. Milestone payments are recorded in the strategic alliance revenue line on the Company’s income statement.
“This milestone payment reflects the continued worldwide growth of VELCADE, a market-leader in relapsed, refractory multiple myeloma, with more than 33,000 patients treated globally,” said Marsha Fanucci, Chief Financial Officer and Senior Vice President at Millennium. “We believe VELCADE represents a more than $1 billion peak worldwide opportunity and, together with J&JPRD, we continue to pursue clinical development to realize the potential of VELCADE.”
Ms. Fanucci will discuss this milestone payment and anticipated other milestones in 2006 in more detail at the Company’s presentation at the Lehman Brothers Ninth Annual Global Healthcare Conference later today. The conference will be webcast and accessible through the Millennium website at http://www.millennium.com.
In June 2003, Millennium entered into an agreement with Ortho Biotech Products, L.P. and its research affiliate, J&JPRD, to collaborate on the commercialization and continued clinical development of VELCADE. Under the terms of the agreement, Ortho Biotech and its affiliate, Janssen-Cilag, commercialize VELCADE outside of the U.S. and Millennium receives royalties on sales outside the U.S. In addition, Millennium may receive payments for achieving clinical, development and regulatory approvals and sales milestones outside of the U.S.
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 Pharmaceuticals K.K. is responsible for commercialization in Japan.
Millennium and Johnson & Johnson Pharmaceutical Research and Development, L.L.C. are investigating VELCADE in both hematologic and solid tumors in trials throughout the U.S. and Europe. VELCADE currently is approved in more than 65 countries worldwide including the U.S., most of Europe, and a number of countries within Latin America and South-East Asia such as Australia, Argentina, China, Korea, Singapore and Thailand. Johnson & Johnson Research & Development, L.L.C., Ortho Biotech Products, L.P., Janssen-Cilag and Janssen Pharmaceuticals K.K. are all members of the Johnson & Johnson Family Of Companies.
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, understanding of disease mechanisms and industrialized drug discovery platform, Millennium is developing an exciting pipeline of innovative product candidates. The Company’s website is http://www.millennium.com.
This press release contains “forward-looking statements,” including statements about the Company’s growth, future operating results, 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® (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: This release is available on the Media section of the Millennium website at http://www.millennium.com Contacts:
Kyle Kuvalanka (investors) Theresa McNeely (media) (617) 761-4734 (617) 679-7405
Source: Millennium Pharmaceuticals, Inc.
