New Data Support High Complete Remission Rates With Velcade (Bortezomib) for Injection Based Therapies in Patients With Newly Diagnosed Multiple Myeloma- Five Oral Presentations at ASCO Annual Meeting Will Further Demonstrate the Strength of VELCADE Combinations in Front-line Multiple Myeloma -
CAMBRIDGE, Mass., May 16, 2008 /PRNewswire/ -- Millennium Pharmaceuticals, The Takeda Oncology Company, today announced that new data from VELCADE clinical studies are scheduled to be featured at the 2008 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois, May 30 - June 3, 2008. The data will highlight the significant efficacy of multiple VELCADE based therapies in patients with newly diagnosed multiple myeloma (MM).
The Company submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) in December 2007 for the use of VELCADE to treat patients with newly diagnosed MM. The filing is based on data from the landmark Phase III VISTA trial. The FDA granted the sNDA priority review and a decision is expected by June 20, 2008. VELCADE is currently the market leader in relapsed multiple myeloma and the only drug approved for the treatment of relapsed mantle cell lymphoma.
"VELCADE based therapies continue to demonstrate unprecedented complete remission rates and survival benefits for patients with newly diagnosed multiple myeloma," said Nancy Simonian, M.D., Chief Medical Officer, Millennium. "Data to be presented at ASCO are expected to support that deep and durable complete remissions are an important indicator for long-term patient outcomes. The continued strength of clinical trial data, combined with the pending FDA approval, will further solidify VELCADE as a key component of the standard of care for this disease."
Newly Diagnosed Multiple Myeloma
Data to be featured at ASCO include the use of VELCADE in both newly diagnosed transplant and non-transplant MM patients. The data from a total of five studies (four Phase II and one Phase III) will highlight how VELCADE based therapies consistently deliver high complete remission (CR) rates and survival benefits to patients with newly diagnosed MM. Oral presentation highlights are scheduled to include:
-- VELCADE Dexamethasone (Vc/D) versus VcAD as Induction Treatment Prior to Autologous Stem Cell Transplantation (ASCT) in Previously Untreated Multiple Myeloma: Updated Data from IFM 2005/01 Trial -- Lead investigator: Jean-Luc Harousseau, M.D., Hospital Hotel-Dieu, Nantes, France -- Abstract #8505: Oral presentation session: Saturday, 31 May, 9:00 a.m. CT -- Total Therapy (TT) for Myeloma: 10 Percent Cure Rate with TT1 Suggested by >10 Year Continuous Complete Remission (CCR): VELCADE in TT3 Overcomes Poor Risk Associated with T (4;14) and DelTP53 in TT2 -- Lead investigator: Bart Barlogie, M.D., Ph.D., Director, Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences -- Abstract #8516: Oral presentation session: Saturday, 31 May, 3:00 p.m. CT -- Efficacy of Induction with CyBorD in Newly Diagnosed Multiple Myeloma -- Lead investigator: Craig Reeder, M.D., Assistant Professor of Medicine - Mayo Clinic College of Medicine -- Abstract #8517: Oral presentation session: Saturday, 31 May, 3:15 p.m. CT -- VELCADE, Pegylated-Lyposomal-Doxorubicin and dexamethasone (PAD) as Induction Therapy Prior to Reduced Intensity ASCT Followed by Lenalidomide and Prednisone (LP) as Consolidation and Lenalidomide Alone as Maintenance -- Lead investigator: Antonio Palumbo, M.D., Chief of the Myeloma Unit; Department of Hematology, University of Torino -- Abstract #8518: Oral presentation session: Saturday, 31 May, 3:30 p.m. CT -- Safety and Efficacy of Lenalidomide, VELCADE and dexamethasone in Patients with Newly Diagnosed Multiple Myeloma: A Phase I/II Study -- Lead investigator: Paul Richardson, M.D., Associate Professor of Medicine, Harvard Medical School; Clinical Director, Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, Boston -- Abstract #8520: Oral presentation session: Saturday, 31 May, 4:15 p.m. CT
Relapsed/Refractory Multiple Myeloma
Data will be presented from several studies of VELCADE based therapies for the treatment of relapsed MM. These data are expected to support the value of adding VELCADE in combination with emerging and established agents, including patients with renal insufficiency.
Non-Hodgkin's Lymphoma (NHL)
Beyond multiple myeloma, the Company continues to pursue and support trials in NHL, which is expected to be the next potential growth opportunity for VELCADE. Currently, VELCADE is the only approved therapy for patients with previously treated mantle cell lymphoma (MCL), the most aggressive form of NHL. ASCO-related data will be featured for VELCADE in combination with established agents in patients with relapsed MCL, indolent NHL and Waldenstrom's Macroglobulinemia, including:
-- Primary therapy of Waldenstrom's Macroglobulinemia with bortezomib, dexamethasone and rituximab: results of WMCTG clinical trial 05-180 -- Lead investigator: Steven Treon, M.D., Ph.D., Assistant Professor in Medicine, Harvard Medical School -- Abstract #8519: Oral presentation session: Saturday, 31 May, 3:45 p.m. CT
In addition to these highlighted trials, the Company is expected to fully accrue patients by the first half of this year for a large, registration-enabling Phase III trial in follicular lymphoma. The trial is designed under a special protocol assessment (SPA) with the FDA of VELCADE and rituximab versus rituximab alone in patients with relapsed follicular lymphoma. Final data are expected in 2010. These trials support the Company's comprehensive development program in NHL.
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), 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 (NHL) and Mantle Cell Lymphoma (MCL)
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, The Takeda Oncology Company, and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Millennium is responsible for commercialization of VELCADE in the U.S. and 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 85 countries worldwide. More than 85,000 patients have been treated with VELCADE globally.
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 also 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 Reversible Posterior Leukoencephalopathy Syndrome (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.
Integrated Safety Data: Safety data from Phase II and III studies of single-agent VELCADE 1.3 mg/m2/dose twice weekly for 2 weeks followed by a 10-day rest period in 1163 patients with multiple myeloma (N=1008) and mantle cell lymphoma (N=155) were integrated and tabulated. In these studies, the safety profile of VELCADE was similar in patients with multiple myeloma and mantle cell lymphoma. In the integrated analysis, the most commonly reported adverse events were asthenic conditions (including fatigue, malaise, and weakness) (64%), nausea (55%), diarrhea (52%), constipation (41%), peripheral neuropathy NEC (including peripheral sensory neuropathy and peripheral neuropathy aggravated) (39%), thrombocytopenia and appetite decreased (including anorexia) (each 36%), pyrexia (34%), vomiting (33%), and anemia (29%). Twenty percent (20%) of patients experienced at least 1 episode of >/= 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.
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, The Takeda Oncology Company, and 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 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. Additional information about Millennium is available through its website, 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: www.millennium.com
Jennifer Snyder Karen Gobler (617) 444-1439 (617) 444-1392
CONTACT: Jennifer Snyder, +1-617-444-1439, or Karen Gobler,+1-617-444-1392, both of Millennium Pharmaceuticals, Inc.
Web site: http://www.millennium.com/
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Posted: May 2008