CHICAGO, June 04, 2007 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. today announced the presentation of positive data for VELCADE, the market-leading therapy for patients with multiple myeloma (MM) who have received at least one prior therapy. These data include results from a Phase II trial for subcutaneous (SC) administration of VELCADE, a new option under evaluation. Results were also presented from the international Phase III trial of VELCADE + DOXIL, which served as the basis for the recent U.S. approval of the combination and showed significant improvement in time to disease progression compared to VELCADE alone, the current standard of care. The VELCADE + DOXIL abstract was selected by the Best of the American Society of Clinical Oncology (ASCO) Program Committee as one of the premier abstracts at the 43rd Annual Meeting in Chicago.
"We and our partner Johnson & Johnson Pharmaceutical Research and Development L.L.C. continue to develop new clinical data that reinforce the role of VELCADE as the U.S. market-leading therapy in previously treated multiple myeloma," said Nancy Simonian, M.D., Chief Medical Officer, Millennium. "These data demonstrate that VELCADE in combination with another active agent can further strengthen the unparalleled impact of VELCADE. We are aggressively pursuing development of a subcutaneous delivery form to broaden alternatives for patients who prefer to receive VELCADE treatment at home."
Prospective Comparison of Subcutaneous to Intravenous Administration of Bortezomib in Patients with Multiple Myeloma: Pharmacokinetics, Efficacy and Toxicity (Abstract #8046)
This randomized trial evaluated the pharmacokinetics/pharmacodynamics (PK/PD), toxicity and response rate of VELCADE in patients treated with either an SC or intravenous (IV) administration option. Results were presented by Philippe Moreau, M.D., University Hospital Hotel-Dieu and showed:
-- Similar bioavailability for the two routes of administration -- Similar safety and tolerability profiles for the two routes of administration with a trend favoring the SC route as evidenced by fewer patients in this group discontinuing therapy -- Identical response rates for the two routes of administration with both groups of patients achieving an overall response rate (complete and partial response) of 42 percent
The trial included 24 patients who were randomized to receive either SC or IV injections of VELCADE at the standard dose of 1.3 mg/m2 twice weekly for two weeks on days 1, 4, 8 and 11 with one week rest for up to eight cycles. Blood samples were taken on days 1 and 11 to measure PK by plasma Cmax (maximum plasma concentration), AUC (area under plasma concentration-time curve) and Tmax (time to Cmax) values and to measure PD by AUE (area under effect curve) and Emax (maximum effect) values. Patients received a median number of six and five cycles in the IV and SC groups, respectively.
Effect of the Combination of Pegylated Liposomal Doxorubicin and Bortezomib on Time to Progression (TTP) and Overall Survival of Patients With Relapsed/Refractory Multiple Myeloma Compared With Bortezomib Alone (Abstract #8002)
"The combination of VELCADE + DOXIL is highly active, with the time to disease progression the strongest in any U.S.-approved label for this patient population," said Jean-Luc Harousseau, M.D., University Hospital Hotel-Dieu. "Based on the Phase II trial, which showed a median overall survival greater than 38 months, we believe that the strong efficacy of the combination in the Phase III trial will extend to a substantial improvement in overall survival as well."
The Phase III study compared the efficacy and safety of the combination of VELCADE + DOXIL to VELCADE monotherapy, the standard of care in patients with previously treated MM. Results were presented by Dr. Harousseau and showed:
-- A survival advantage was observed for the VELCADE + DOXIL combination, after approximately 20 percent of events occurred (p<0.05, hazard ratio=1.406, 95 percent confidence interval [1.002; 1.972]) -- Median time to progression (TTP) of 9.3 months for the combination, a 43 percent, highly statistically significant reduction in risk of disease progression over the control arm (p<0.00001) -- A predictable safety profile consistent with the known toxicities of the two agents, including thrombocytopenia, neutropenia and anemia
The trial included 646 patients who had received at least one prior therapy. Patients were randomized in a one-to-one ratio, with 322 patients receiving VELCADE at 1.3 mg/m2 on days 1, 4, 8 and 11 of the 21-day cycle and 324 patients receiving the same dose and schedule of VELCADE with the addition of DOXIL at 30 mg/m2 given on day 4 of each cycle. Patients were treated for up to eight cycles. The primary endpoint of the study was TTP as defined by the interval between the date of randomization and the date of disease progression, including relapse after complete response or death due to disease progression. In both arms, 66 percent of patients had received more than two prior therapies before entering the trial. Responses were assessed by European Group for Blood and Marrow Transplantation (EBMT) criteria.
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 20,000 new cases are diagnosed each year. Worldwide there are approxi mately 74,000 new cases and over 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).
About Millen nium
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. T he 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.
Contacts: Jennifer Snyder (media) Kyle Kuvalanka (investors) (617) 448-0281 (857) 498-0818
CONTACT: media, Jennifer Snyder, +1-617-448-0281, or investors, KyleKuvalanka, +1-857-498-0818, both of Millennium Pharmaceuticals, Inc.
Web site: http://www.millennium.com/
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