New Data to Support Velcade (Bortezomib) For Injection Based Therapies as Setting New Standards in The Care of Newly Diagnosed Patients With Multiple Myeloma
CAMBRIDGE, Mass., November 26, 2007 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. today announced that new data from more than 130 abstracts of VELCADE clinical studies are scheduled to be featured at the 49th ASH Annual Meeting in Atlanta, Georgia, December 8-11, 2007. The data will highlight the significant efficacy of VELCADE in multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL).
"VELCADE based therapies have unprecedented complete remission rates and survival benefits in multiple myeloma," said Nancy Simonian, M.D., Chief Medical Officer, Millennium. "Data to be presented at ASH from three large, randomized Phase III trials will support the expansion of our market-leading therapy into the front-line multiple myeloma setting."
Front-Line Multiple Myeloma
Data to be featured at ASH will continue to build on the growing body of evidence that supports the use of VELCADE in both newly diagnosed transplant and non-transplant patients. The data from a total of 20 Phase II and Phase III front-line studies will highlight the efficacy of VELCADE based therapies with consistently high CR and survival benefits. Phase III presentation highlights are scheduled to include:
-- A Phase III Study Comparing VELCADE, Melphalan and Prednisone (VMP) with Melphalan Prednisone (MP) in Newly Diagnosed Multiple Myeloma - Lead investigator: Jesus San-Miguel, M.D., Ph.D., Hospital Universitario de Salamanca - Abstract #76: Oral presentation session: Sunday 9 December, 4:30 p.m. -- VELCADE Dexamethasone (VEL/D) versus VAD as Induction Treatment Prior to Autologous Stem Cell Transplantation (ASCT) in Newly Diagnosed Multiple Myeloma - Lead investigator: Jean-Luc Harousseau, M.D., University Hospital Hotel-Dieu - Abstract: #450: Oral presentation session: Monday 10 December, 1:30 p.m. -- VELCADE, Thalidomide and Dexamethasone (VTD) versus Thalidomide Dexamethasone (TD) in Preparation for Autologous Stem-Cell (SC) Transplantation (ASCT) in Newly Diagnosed Multiple Myeloma - Lead investigator: Michele Cavo, M.D., Seragnoli Institute of Hematology, University of Bologna - Abstract: #73: Oral presentation session: Sunday 9 December, 4:30 p.m.
Relapsed/Refractory Multiple Myeloma
Data will be presented from 23 studies of VELCADE based therapies for the treatment of relapsed MM. These data, including settings where VELCADE is used for retreatment and in patients with renal impairment, support the importance of adding VELCADE in combination with numerous emerging and established agents.
VELCADE is the only approved therapy in previously treated mantle cell lymphoma (MCL), the most aggressive form of NHL. Data will be featured on VELCADE in various subsets of NHL, including follicular and the use of biomarkers as a predictor of patient response.
About Multiple Myeloma
Multiple myeloma is the second most common hematologic malignancy and although the disease is predominantly a cancer of the elderly (the median age of onset is 70 years of age), recent statistics indicate both increasing incidence and younger age of onset. In the U.S., more than 50,000 individuals have MM and 20,000 new cases are diagnosed each year. Worldwide there are approximately 74,000 new cases and over 45,000 deaths annually.
About Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma
NHL is the most common hematological cancer, the fifth leading cause of cancer death and the second fastest growing form of cancer in the U.S. The prevalence of NHL in the U.S. is approximately 400,000 patients, including approximately 200,000 patients with diffuse large B-cell lymphoma, 100,000 patients with follicular and marginal zone lymphoma and 10,000 with MCL. There are approximately 54,000 new cases of NHL diagnosed in the U.S. per year, and 19,000 deaths are attributed to the disease annually.
MCL is an aggressive, rapidly progressive subtype of NHL, and is not curable with standard treatment. The median life expectancy for a patient with MCL following first relapse is one to two years.
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. For a limited period of time, Millennium and Ortho Biotech Inc. are co-promoting VELCADE in the U.S. VELCADE is approved in more than 80 countries worldwide.
In the U.S., VELCADE is indicated for the treatment of patients with multiple myeloma who have received at least one prior therapy. VELCADE is indicated for the treatment of patients with mantle cell lymphoma 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. In the European Union and many other countries worldwide, VELCADE is approved for patients with multiple myeloma after first relapse.
Risks associated with VELCADE therapy include new or worsening peripheral neuropathy, hypotension observed throughout therapy, cardiac and pulmonary disorders, gastrointestinal adverse events, thrombocytopenia, neutropenia and tumor lysis syndrome. Women of childbearing potential should avoid becoming pregnant while being treated with VELCADE. Cases of severe sensory and motor peripheral neuropathy have been reported. The long-term outcome of peripheral neuropathy has not been studied in mantle cell lymphoma. Acute development or exacerbation of congestive heart failure, and/or new onset of decreased left ventricular ejection fraction has been reported, including reports in patients with few or no risk factors for decreased left ventricular ejection fraction. There have been rare reports of acute diffuse infiltrative pulmonary disease of unknown etiology such as pneumonitis, interstitial pneumonia, lung infiltration and Acute Respiratory Distress Syndrome in patients receiving VELCADE. Some of these events have been fatal. A higher proportion of these events have been reported in Japan. There have been rare reports of RPLS in patients receiving VELCADE. RPLS is a rare, reversible, neurological disorder which can present with seizure, hypertension, headache, lethargy, confusion, blindness, and other visual and neurological disturbances. VELCADE is associated with thrombocytopenia and neutropenia. There have been reports of gastrointestinal and intracerebral hemorrhage in association with VELCADE. Transfusions may be considered. Complete blood counts (CBC) should be frequently monitored during treatment with VELCADE. Rare cases of acute liver failure have been reported in patients receiving multiple concomitant medications and with serious underlying medical conditions.
Safety Data of VELCADE as a Single-Agent: In 1163 patients in multiple myeloma and mantle cell lymphoma studies, the most commonly reported adverse events were asthenic conditions (64%), nausea (55%), diarrhea (52%), constipation (41%), peripheral neuropathy (39%), thrombocytopenia (36%), appetite decrease, including reports of anorexia (36%), pyrexia (34%), vomiting (33%) and anemia (29%). Twenty percent of patients reported at least one episode of grade 4 toxicity; the most common grade 4 toxicities were thrombocytopenia (5%) and neutropenia (3%). Fifty percent of patients reported serious adverse events. The most commonly reported serious adverse events were pneumonia (7%), pyrexia (6%), diarrhea (5%), vomiting (4%), and nausea, dehydration, dyspnea and thrombocytopenia (each 3%).
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).
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 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.
CONTACT: Media, Jennifer Snyder, +1-617-444-1439, or Investors, KyleKuvalanka, +1-617-761-4734, both of Millennium Pharmaceuticals, Inc.
Web site: http://www.millennium.com/
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Posted: November 2007