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Biotech / Medical : Millennium Pharmaceuticals, Inc. (MLNM) -- Ignore unavailable to you. Want to Upgrade?

To: Icebrg who wrote (2254)	11/2/2004 4:21:52 PM
From: tuck	Respond to of 3044

>>CAMBRIDGE, Mass., Nov. 2 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) today announced that the Food and Drug Administration (FDA) has granted VELCADE fast track designation for relapsed and refractory mantle cell lymphoma, an aggressive form of non-Hodgkin's lymphoma (NHL) which accounts for approximately six percent of all lymphomas. Currently, VELCADE is being evaluated as a single agent in a Company-sponsored multicenter Phase II clinical trial for the treatment of mantle cell lymphoma in addition to multiple investigator-initiated trials. These trials are part of an ongoing research collaboration between Millennium and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. to jointly investigate VELCADE in hematologic and solid tumors. VELCADE is currently indicated for the treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. "We are pleased that the FDA has recognized the unmet medical need of patients suffering from mantle cell lymphoma," said David Schenkein, M.D., vice president, clinical oncology development, Millennium. "Mantle cell lymphoma remains one of the deadliest forms of cancer and is generally considered incurable. Millennium remains committed to the clinical development and registration of VELCADE as a treatment for the critical unmet medical needs of patients suffering from mantle cell lymphoma." Under the FDA Modernization Act of 1997, designation as a fast track product indicates that the FDA will facilitate the development and expedite the review of a drug if it is intended for the treatment of a serious life- threatening condition, and demonstrates the potential to address unmet medical needs for such a condition. Specifically, this designation allows for the FDA to accept on a rolling basis portions of a marketing application for review prior to the completion of a final document. The fast track designation is based on preliminary data from an ongoing Company-sponsored phase II clinical trial of VELCADE in patients with relapsed or refractory mantle cell lymphoma, and the commitment to a full development program designed to lead to registration. The trial, initiated in June 2003, is designed to assess time to progression, response rate, duration of response and overall survival in patients with relapsed or refractory mantle cell lymphoma following one or two prior chemotherapeutic regimens. Millennium anticipates interim data will be presented at the American Society of Clinical Oncology (ASCO) annual meeting in 2005. Support of this designation was based on data from four separate Phase II investigator-initiated studies of VELCADE as a single agent for the treatment of indolent and aggressive NHL which were presented at the 2003 and 2004 American Society of Clinical Oncology (ASCO) meetings and the 2003 American Society of Hematology (ASH) meeting. Additionally, Millennium anticipates further data from two of these studies will be submitted for presentation at the December American Society of Hematology 46th annual meeting in San Diego, Calif. Millennium and Johnson & Johnson Pharmaceutical Research & Development jointly continue to investigate VELCADE globally in both hematologic and solid tumors and currently have approximately 80 ongoing clinical trials. VELCADE is currently approved in the United States, 27 European Union states, South Korea, Argentina and Israel. VELCADE is being co-developed by Millennium and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Millennium is responsible for commercialization of VELCADE in the U.S.; Ortho Biotech and Janssen-Cilag are responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical K.K. will be responsible for Japan. About Mantle Cell Lymphoma Mantle cell lymphoma, an aggressive form of non-Hodgkin's lymphoma, accounts for approximately six percent of all lymphomas. This form of lymphoma is often widespread when diagnosed and typically involves the lymph nodes, bone marrow and spleen. Only one fifth of patients survive more than five years following diagnosis; median survival is three years.<< snip Every little bit helps. Cheers, Tuck

To: Icebrg who wrote (2254)	11/5/2004 12:50:07 AM
From: tuck	Respond to of 3044

[Cost effectiveness of bortezomib in the treatment of advanced multiple myeloma] >>Manag Care Interface. 2004 Sep;17(9):52-61. Cost effectiveness of bortezomib in the treatment of advanced multiple myeloma. Mehta J, Duff SB, Gupta S. Hematopoietic Stem Cell Transplantation Program, The Feinberg School of Medicine, Northwestern University, Chicago, USA. j-mehta@northwestern.edu This study evaluated the cost effectiveness of bortezomib in relapsed, refractory myeloma, relative to best supportive care (BSC) and thalidomide. Data were derived from the phase 2 pivotal study of bortezomib, a Delphi panel of six myeloma thought leaders, and published literature. Objective assumptions regarding treatment choices and consequences (response and complications), and actual cost data were used. Bortezomib was found to be cost effective relative to BSC and thalidomide. Sensitivity analyses demonstrated the robustness of the results. These data suggest that bortezomib provides a cost-effective treatment option and the best value (in terms of cost/life-yr gained) among the currently available therapeutic options for relapsed, refractory myeloma.<< So what if they inlicensed it? Cheers, Tuck