Healthcare Industry News: Janssen
News Release - April 17, 2007
Millennium Discovers Biomarkers Potentially Predictive of Response to VELCADE(R) (Bortezomib) for InjectionFindings Published in Blood Highlight Millennium Leadership in Personalized Medicine and Could Strengthen the Role of VELCADE as Foundation of Therapy in Broad Range of Multiple Myeloma Patients
CAMBRIDGE, Mass., April 17 (HSMN NewsFeed) -- Findings published in the April 15th issue of Blood show that a team of researchers led by Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM ) has discovered biomarkers which may lead to identifying multiple myeloma patients likely to respond to VELCADE. VELCADE is the U.S. market leading therapy for previously treated multiple myeloma patients with an unsurpassed median survival of 29.8 months as a single agent.
These findings add to the body of evidence that supports the role of VELCADE in the treatment of a broad range of multiple myeloma patients and highlight the applicability of genomics research. This research, in combination with similar ongoing studies, may ultimately lead to improved outcomes for patients.
The identification of these biomarkers was the result of a collaborative effort by researchers from Millennium and leading multiple myeloma academic centers. These centers included Dana-Farber Cancer Institute, Boston; Myeloma Institute of Research and Therapy at the University of Arkansas for Medical Services, Little Rock; Mayo Clinic, Scottsdale; and Department of Hematology, Erasmus Medical Center, Rotterdam.
The combined team performed genomics analyses on tumor samples from multiple myeloma patients in VELCADE clinical trials. These trials included the APEX Phase III study, which demonstrated the superiority of VELCADE over standard-of-care dexamethasone in previously treated multiple myeloma patients and is one of the first and largest prospective randomized trials to include genomics analyses.
Findings from the analyses showed that patients with an increased expression of genes in the NFk-B and adhesion molecule pathways may be more sensitive to VELCADE therapy. Additionally, these findings showed that the biomarkers did not predict sensitivity to dexamethasone therapy, indicating that the biomarkers may be specific to VELCADE.
"Millennium is recognized as a leader in personalized medicine, and this publication is a testament to the strength of our clinical innovation," said Nancy Simonian, M.D., Chief Medical Officer, Millennium. "The genomic findings add further knowledge about VELCADE efficacy in treating a broad range of multiple myeloma patients."
Millennium and its co-development partner, Johnson & Johnson Pharmaceutical Research and Development, L.L.C. (J&JPRD) is continuing genomics research on VELCADE in additional trials. Studies include a Phase III trial conducted by the Dutch and German co-operative groups, HOVON and GMMG, which is evaluating a VELCADE based combination in patients with newly diagnosed multiple myeloma. In addition, genomics research is ongoing in a Phase III trial evaluating a VELCADE based combination therapy in indolent non-Hodgkin's lymphoma.
"While the published results represent an important step forward in our genomics research, the next critical step is to conduct similar analyses with VELCADE in combination with other anti-cancer agents," said George Mulligan PhD, Associate Director, Translational Medicine, Millennium. "We are committed to improving outcomes for multiple myeloma patients and this work should bring us closer to determining optimal treatment strategies."
VELCADE is being co-developed by Millennium and J&JPRD. 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, 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%), 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 nine innovative product candidates. Millennium's website is http://www.millennium.com.
This press release contains "forward-looking statements," including statements about the Company's growth and research 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® (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.
Source: Millennium Pharmaceuticals
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