Millennium Pharma - Velcade Fast Track!!!!!!!!!!!!!!!! - 500 Beiträge pro Seite

[Snake3000]

Press Release Source: Millennium Pharmaceuticals, Inc.


FDA Grants VELCADE(R) (bortezomib) for Injection Fast Track Status for Relapsed and Refractory Mantle Cell Lymphoma
Tuesday November 2, 4:15 pm ET
-- Phase II mantle cell lymphoma development an integral component of Company`s broad NHL program --


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.
(Logo: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO )
"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.

[Snake3000]

Klares Kaufsignal für den morgigen Tag! After Hour: +4%

Lediglich ein neuer US-President (Kerry) könnte uns einen Strich durch die Rechnung machen. Seine Pläne bezüglich der härteren Reglementierung des Pharma/BiotechBereichs sollten eine "underperformance" des Biotechsektors mit sich bringen.

Schön Gruß
Snake3000

[Boersenkrieger]

@Snake

mir ist trotzdem kerry lieber auch wenn´s meine MLNM und CELG treffen wird...kerry dürfte für die us-wirtschaft wesentlich besser sein ! ...für stammzellenaktien wäre er auch besser... habe leider keine ausser geron für 500 Euro nur