Velcade (bortezomib) for Injection Survival Data in Front-Line Multiple Myeloma Patients to be Featured at 11th International Myeloma Workshop-- More than 70 abstracts highlight VELCADE efficacy in broad range of patients and across continuum of care --
CAMBRIDGE, Mass., June 19, 2007 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. today announced that data for VELCADE, the market leading therapy with unsurpassed single-agent efficacy for patients with previously treated multiple myeloma (MM), will be featured at the upcoming International Myeloma Workshop (IMW) in Kos, Greece, June 25-30, 2007.
"Clinical data to be presented next week will underscore the crucial role of VELCADE based therapies in the front-line multiple myeloma treatment setting. These results will show that the high complete response rates seen with VELCADE based combinations translate to some of the most impressive survival rates to date," said Deborah Dunsire, M.D., President and Chief Executive Officer, Millennium. "These are exciting data for the field of multiple myeloma as we see that combining the power of VELCADE with other active agents substantially prolonged the lives of patients."
VELCADE in Front-Line MM Patients
Previously presented data have shown that VELCADE based combinations produce very high complete and near complete response rates. Data presented at this conference are expected to provide further evidence that this benefit leads to prolonged survival. Abstract highlights include:
-- Phase I / II Study of Upfront VELCADE, Lenalidomide and Dexamethasone in Multiple Myeloma: Early Results * Lead investigator: Paul Richardson, M.D., Dana-Farber Cancer Institute * Abstract #715; Poster session: Thursday 28th June, 4:30 p.m. -- Front-line VELCADE, Melphalan and Prednisone (VMP) in Elderly Multiple Myeloma Patients: Extended Follow-Up * Lead investigator: Maria-Victoria Mateos, M.D., PhD., Grupo Espanol de Multiple Myeloma * Abstract #718; Poster session: Thursday 28th June, 4:30 p.m. -- Combination Therapy with VELCADE, DOXIL(R) (pegylated liposomal doxorubicin) and Dexamethasone (VDD) in Newly Diagnosed Myeloma: Updated Results of a Phase II Clinical Trial * Lead investigator: Andrzej Jakubowiak, M.D., PhD., University of Michigan Comprehensive Cancer Center * Abstract #721; Poster session: Thursday 28th June, 4:30 p.m. -- Long-term Follow-Up of VELCADE, Doxorubicin and Dexamethasone (referred to as VcAD or PAD) for Untreated Multiple Myeloma * Lead investigator: Rakesh Popat, M.D., St. Bartholomew's Hospital Abstract #725; Poster session: Thursday 28th June, 4:30 p.m.
VELCADE in Previously Treated MM Patients
Data are expected to further support VELCADE as a foundation for combination therapy showing very high complete response rates in both VELCADE naive and retreated patients. Abstract highlights include:
-- Weekly VELCADE, Cyclophosphamide and Prednisone in Myeloma * Lead investigator: Donna Reece, M.D., Princess Margaret Hospital * Abstract #639; Poster session: Thursday 28th June, 4:30 p.m. -- Phase II Study of VELCADE, Lenalidomide and Dexamethasone in Relapsed / Refractory Multiple Myeloma * Lead investigator: Paul Richardson, M.D., Dana-Farber Cancer Institute * Abstract #660; Poster session: Thursday 28th June, 4:30 p.m.
VELCADE Addresses Multiple Myeloma-Related Complications
New data are expected to show that VELCADE is active and safe in patients with renal impairment and bone degeneration. These data will demonstrate VELCADE differentiation in benefiting a broad range of patients. Abstract highlights include:
-- VELCADE Plus Dexamethasone Therapy Induces Osteoblast Activation in Responsive Patients with Multiple Myeloma * Lead investigator: Shuji Ozaki, M.D., The University of Tokushima Graduate School of Health Biosciences * Abstract #311; Poster session: Tuesday 26th June, 4:30 p.m. -- Effect of VELCADE Monotherapy and VELCADE Based Regimens on Bone Metabolism in Patients with Relapsed / Refractory Multiple Myeloma * Lead investigator: Evangelos Terpos, M.D., General Airforce Hospital * Abstract #320; Poster session: Tuesday 26th June, 4:30 p.m. -- Cystatin-C: An Early Marker of Renal Impairment and an Independent Predictive Factor for Survival in Multiple Myeloma. Reduction Post VELCADE Therapy * Lead investigator: Evangelos Terpos, M.D., General Airforce Hospital * Abstract #227; Poster session: Tuesday 26th June, 4:30 p.m. -- VELCADE in Renally Impaired Multiple Myeloma Patients * Lead investigator: Jesus San Miguel, M.D., PhD., Hospital Universitario de Salamanca * Abstract #1114; Poster session: Thursday 28th June, 4:30 p.m.
VELCADE Shows Potential in Additional Diseases and in Combination with Emerging Agents
New data will highlight VELCADE efficacy in amyloidosis, a disease of high unmet need, and in combination with new agents such as HSP90-, AKT- and mTOR-inhibitors. Abstract highlights include:
-- Treatment of Light Chain (AL) Amyloidosis with the Combination of VELCADE and Dexamethasone * Lead investigator: Efstathios Kastritis, M.D., Alexandra Hospital, University of Athens School of Medicine * Abstract #913; Poster session: Thursday 28th June, 4:30 p.m. -- VELCADE and Tanespimycin in Multiple Myeloma: Pharmacology, Safety and Activity in Relapsed / Refractory Patients * Lead investigator: Paul Richardson, M.D., Dana-Farber Cancer Institute * Abstract #610; Poster session: Thursday 28th June, 4:30 p.m. -- A Multicenter Phase I / II Trial of VELCADE and Perifosine (KRX-0401) in Relapsed / Refractory Multiple Myeloma Patients Previously Treated with VELCADE: Preliminary Results * Lead investigator: Paul Richardson, M.D., Dana-Farber Cancer Institute * Abstract #608; Poster session: Thursday 28th June, 4:30 p.m. -- Combination of the mTOR-Inhibitor Rapamycin and Proteasome Inhibitor VELCADE is Synergistic In Vitro in Multiple Myeloma * Lead investigator: Xavier Leleu, M.D., Centre Hospitalier Regional Universitaire de Lille * Abstract #534; Poster session: Tuesday 26th June, 4:30 p.m.
About Multiple Myeloma (MM)
Multiple myeloma is the second most common hematologic malignancy and although the disease is predominantly a cancer of the elderly (the average age of onset is 65 to 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 close to 20,000 new cases are diagnosed each year. Worldwide there are approximately 74,000 new cases and more than 45,000 deaths annually.
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. will co-promote 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, 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: In 1163 patients in multiple myeloma and mantle cell lymphoma studies, the most commonly reported adverse events were asthenic conditions (64%), nausea (55%) in single-agent VELCADE, 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.
Editors' Note: This press release is also available under the Media section of the Company's website at: www.millennium.com. All session times listed are Eastern European Daylight Time.
CONTACT: Jennifer Snyder (media), +1-617-444-1439, or Kyle Kuvalanka(investors), +1-857-498-0818
Web site: http://www.millennium.com/
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Posted: June 2007