Healthcare Industry News: Janssen
News Release - April 18, 2006
Millennium and Johnson & Johnson Pharmaceutical Research and Development Initiate Phase III Clinical Trial with VELCADE(R) (bortezomib) for Injection in Follicular Non-Hodgkin's LymphomaCAMBRIDGE, Mass., April 18 (HSMN NewsFeed) -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM ) along with co-development partner Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) today announced the initiation of a Phase III clinical trial of VELCADE in combination with rituximab in patients with relapsed or refractory follicular lymphoma, a subtype of non-Hodgkin's lymphoma (NHL). This study builds on clinical data observed in previous trials of VELCADE that showed high objective response rates and a favorable safety profile across a variety of lymphomas.
"We accelerated the timeline for initiating this high-priority trial," said Robert Tepper, M.D., President, Research & Development, Millennium Pharmaceuticals, Inc. "Based on previous study results that demonstrated substantial single-agent and combination activity in this patient population, we are excited about the potential of VELCADE to benefit patients with this form of NHL, a disease that is not curable with standard therapy."
The Phase III study is expected to enroll approximately 670 patients with relapsed or refractory, rituximab na´ve or sensitive follicular NHL. Patients will be randomized to either the combination regimen of once-weekly VELCADE plus rituximab or rituximab alone. The primary endpoint is progression-free survival. Secondary endpoints of the study include the overall response rate and duration of response as assessed by the International Workshop to Standardize Response Criteria for NHL (IWRC). The weekly dose of VELCADE in this study is 1.6 mg/m2 and rituximab will be administered at 375 mg/m2.
This study builds on previous clinical trials results of VELCADE in NHL, including data from a Phase II study presented in December 2005 at the 47th Annual Meeting of the American Society of Hematology. In a randomized, multi- center Phase II study comparing weekly and twice-weekly VELCADE in combination with the standard-weekly dose of rituximab, the more convenient weekly arm showed a response rate similar to that of the twice-weekly arm, with an improved safety profile. Results from the 74 evaluable patients (39 in the weekly arm and 35 in the twice-weekly arm) included overall response rates, including complete responses, of 54 percent in the weekly arm, and 51 percent in the twice-weekly arm with a similar total amount of drug received in both treatment arms. Additionally, data presented at the 9th International Conference of Malignant Lymphoma in Lugano, Switzerland in June 2005 demonstrated response rates for single-agent VELCADE as high as 56 percent in patients with relapsed or refractory follicular lymphoma. The most common adverse events seen in these trials were gastrointestinal symptoms, neutropenia, thrombocytopenia, fatigue and peripheral neuropathy.
About Non-Hodgkin's Lymphoma (NHL)
Non-Hodgkin's lymphoma is the most common hematological cancer and the fifth leading cause of cancer death in the U.S. There are approximately 56,400 new cases diagnosed per year, it is responsible for 19,200 deaths annually and is the second fastest growing form of cancer in the U.S.(1) The prevalence of NHL is approximately 400,000, including 77,000 patients with follicular lymphoma and approximately 10,000 with mantle cell lymphoma.(2,3) According to the American Cancer Society, the incidence of NHL has more than doubled since the 1970s. The average age of diagnosis is between 55 and 60.
VELCADE is indicated for the treatment of multiple myeloma patients 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.
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.
In 331 patients who were treated with VELCADE in a Phase III study, the most commonly reported adverse events were asthenic conditions (61%), diarrhea (57%), nausea (57%), constipation (42%), peripheral neuropathy (36%), vomiting (35%), pyrexia (35%), thrombocytopenia (35%), psychiatric disorders (35%), anorexia and appetite decreased (34%), parasthesia (27%), dysesthesia (27%), anemia and headache (26%), and cough (21%). Fourteen percent of patients reported at least one episode of grade 4 toxicity; the most common grade 4 toxicities were thrombocytopenia (4%), neutropenia (2%), and hypercalcemia (2%). A total of 144 patients on VELCADE (44%) reported serious adverse events (SAEs) during the study. The most commonly reported SAEs were pyrexia (6%), diarrhea (5%), dyspnea, pneumonia (4%), and vomiting (3%).
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. VELCADE is approved in 66 countries worldwide. VELCADE is also approved in the European Union as a second-line treatment.
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. The Company'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 candidate products. The Company's website is http://www.millennium.com.
This press release contains "forward-looking statements," including statements about the Company's discovery 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.
Editor's Note: This release is available under the Media section on the Company's website at http://www.millennium.com.
(1) 2005, American Cancer Society, Inc., Surveillance Research
(2) SEER, SARGA, and Decision Resources (for growth rate) data
(3) Federico et al., BLOOD 95(3): 783-789; 2000
Source: Millennium Pharmaceuticals
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