InvestorsHub Logo
Followers 35
Posts 6426
Boards Moderated 0
Alias Born 07/07/2002

Re: None

Wednesday, 12/04/2002 4:30:18 PM

Wednesday, December 04, 2002 4:30:18 PM

Post# of 704019
MLNM flying:

Millennium Plans To Submit a New Drug Application for Velcade(TM) (Bortezomib) for Injection
CAMBRIDGE, Mass., Dec 4, 2002 /PRNewswire-FirstCall via COMTEX/ -- Millennium
Pharmaceuticals, Inc. (Nasdaq: MLNM) today announced that the Company intends to
file a New Drug Application (NDA) with the U.S. Food and Drug Administration
(FDA) to market VELCADE as a treatment for relapsed and refractory multiple
myeloma by early 2003. Earlier this year, VELCADE was granted fast-track status
by the FDA as having the potential to treat a serious, life-threatening
condition and address an unmet medical need. The NDA is planned to be submitted
under the provisions of Subpart H - Accelerated Approval of New Drugs for
Serious or Life-Threatening Illnesses. The Company also plans to file a
Marketing Authorisation Application (MAA) to the European Agency for the
Evaluation of Medicinal Products (EMEA) within the same time frame.

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

The NDA filing for VELCADE will be based on the final results of the company's
major phase II clinical trial, which will be presented at the upcoming meeting
of the American Society for Hematology. Further, the Company is committed to
completing its international, multi-center, phase III (APEX) trial of VELCADE in
patients with multiple myeloma and moving ahead with ongoing and new phase I/II
trials in patients with various solid tumors.

"The Company's intention to move forward with an NDA filing for VELCADE
represents an important step in realizing our corporate mission of making new
treatment options based on novel mechanisms available to patients with
significant unmet medical needs," said Mark Levin, chairperson and chief
executive officer at Millennium.

Multiple myeloma is a cancer of the bone marrow in which white blood cells,
normally responsible for the production of antibodies (proteins that fight
infection and disease), are overproduced and cause decreased production of
normal red and white blood cells and normal disease-fighting antibodies, as well
as the growth of tumors that spread to multiple sites - hence the term multiple
myeloma. The decreased white blood cell production damages the immune system
while the myeloma tumors cause bone destruction that manifests as pain and
fractures.

About Millennium

Millennium Pharmaceuticals, Inc., a leading biopharmaceutical company, co-
promotes INTEGRILIN(R) (eptifibatide) Injection, a market-leading therapy for
patients with acute coronary syndrome, and has a robust clinical development
pipeline of product candidates. The Company's research, development and
commercialization activities are focused in four disease areas: cardiovascular,
oncology, inflammation and metabolic. By applying its knowledge of the human
genome, its understanding of disease mechanisms, and its industrialized
technology platform, Millennium is developing breakthrough personalized medicine
products. Headquartered in Cambridge, Mass. Millennium also has facilities in
South San Francisco, Calif. and Cambridge, UK.



Join the InvestorsHub Community

Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.