VELCADE(TM) (Bortezomib) Recommended for European Marketing Approval
Thursday January 22, 11:51 am ET
-- Potential new treatment for patients in Europe with relapsed and refractory multiple myeloma --
# CAMBRIDGE, Mass., Jan. 22 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc., (Nasdaq: MLNM - News) today announced that the European Medicines Evaluation Agency's (EMEA) Committee on Proprietary Medicinal Products (CPMP) has issued a positive opinion to recommend approval under exceptional circumstances for VELCADE (bortezomib) for the treatment of patients with multiple myeloma who have received at least two prior therapies and have demonstrated disease progression on their last therapy. The Marketing Authorization Application for VELCADE (bortezomib) was submitted to the EMEA in January 2003 and accepted for review in February 2003.
The CPMP's opinion was issued today in London, U.K., and will be forwarded to the European Commission. The Company anticipates that the Commission will ratify the opinion and will issue a Marketing Authorization in the second quarter of this year. Under a Marketing Authorization, a single license would be granted to Millennium to market VELCADE (bortezomib) in the 15 member states of the European Union, the 10 accession member countries, plus Norway and Iceland.
"The Committee's positive recommendation to approve this application represents another significant step toward the Company's global mission of developing breakthrough products that make an important difference in patients' lives," said David Schenkein, M.D., vice president, oncology clinical development at Millennium. "With its new and unique mechanism of action of inhibiting the proteasome, VELCADE (bortezomib) is different from traditional chemotherapies and represents a completely new approach to treating cancer."
Under the terms of the co-development and commercialization agreement for VELCADE (bortezomib), Ortho Biotech and its affiliate, Janssen-Cilag, will commercialize VELCADE (bortezomib) outside of the U.S., including Europe. Millennium will receive royalties from Ortho Biotech and its affiliate Janssen-Cilag on sales outside the U.S.
"We are pleased to have worked in partnership with Millennium to secure a positive CPMP opinion for VELCADE (bortezomib) in Europe," said Martine George, M.D., vice president, global clinical research and development for Johnson & Johnson Pharmaceutical Research and Development, L.L.C. "We are committed to bringing this important medication forward to multiple myeloma patients in Europe as quickly as possible."
In the U.S., the drug was approved in May 2003 for patients with multiple myeloma who have received at least two prior therapies and have demonstrated disease progression on the last therapy. Millennium continues to investigate the full potential of VELCADE (bortezomib) in both hematologic and solid tumors and currently has over 80 ongoing or planned clinical trials.
About VELCADE® (bortezomib) for Injection
VELCADE, the first of a new class of medicines called proteasome inhibitors, is the first treatment in more than a decade to be approved for patients with multiple myeloma -- a cancer of the blood. Millennium received approval from the U.S. Food and Drug Administration (FDA) on May 13, 2003 to market VELCADE for the treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. The effectiveness of VELCADE is based on response rates. There are no controlled trials demonstrating a clinical benefit such as an improvement in survival.
VELCADE is being co-developed by Millennium and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Millennium is responsible for commercialization of VELCADE in the U.S.; Ortho Biotech and Janssen-Cilag will be responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical K.K. will be responsible for Japan.
VELCADE has a generally predictable, manageable safety profile (with appropriate monitoring and, if necessary, dose modification). VELCADE is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol.
In 228 patients who were treated with VELCADE® (bortezomib) for Injection in two phase II studies of multiple myeloma, the most commonly reported adverse events were asthenic conditions (including fatigue, malaise and weakness) (65 percent), nausea (64 percent), diarrhea (51 percent), appetite decreased (including anorexia) (43 percent), constipation (43 percent), thrombocytopenia (43 percent), peripheral neuropathy (including peripheral sensory neuropathy and peripheral neuropathy aggravated) (37 percent), pyrexia (36 percent), vomiting (36 percent), and anemia (32 percent). Fourteen percent of patients experienced at least one episode of grade four toxicity, with the most common toxicity being thrombocytopenia (3 percent) and neutropenia (3 percent). A total of 113 (50 percent) of the 228 patients experienced serious adverse events (SAEs). The most commonly reported SAEs included pyrexia (7 percent), pneumonia (7 percent), diarrhea (6 percent), vomiting (5 percent), dehydration (5 percent) and nausea (4 percent).
For more information about VELCADE clinical trials, patients and physicians can contact the Millennium Medical Product Information Department at 1-(866)-VELCADE.
About Millennium
Millennium Pharmaceuticals, Inc., a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE, a novel cancer product, co- promotes INTEGRILIN® (eptifibatide) Injection, a market-leading cardiovascular product, and has a robust clinical development pipeline of product candidates. The Company's research, development and commercialization activities are focused in three therapeutic areas: oncology, cardiovascular, 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.
This press release contains "forward-looking statements," including statements about our growth and future operating results, discovery and development of products, potential acquisitions, strategic alliances and intellectual property. 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 our drug discovery and clinical development programs; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialize products and services based on our work; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; the commercial success of INTEGRILIN and VELCADE; 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 we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim 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 under the Media section on the Company's website at www.millennium.com.
Contacts:
Kelly Lindenboom (media)
(617) 679-7405
Clare Midgley (investor)
(617) 679-7480
Source: Millennium Pharmaceuticals, Inc. |
