Abraxane
paclitaxel
Treatment for Breast CancerAmerican Pharmaceutical Partners and American BioScience Announce FDA Acceptance of New Drug Application of Abraxane for the Treatment of Metastatic Breast Cancer
SCHAUMBURG, Ill., May 10, 2004 -- American Pharmaceutical Partners, Inc. (Nasdaq: APPX) and American BioScience, Inc. (ABI) today announced that the New Drug Application (NDA) for Abraxane has been accepted for filing with standard review by the U.S. Food and Drug Administration (FDA), indicating the FDA has determined that the application is sufficiently complete to permit a substantive review. The final portion of the NDA was submitted on March 8, 2004 under FDA's Fast Track designation, as a treatment for metastatic breast cancer.
"I am very proud of the tremendous effort by the entire development team in accomplishing this successful filing of an electronic NDA. FDA's acceptance of this NDA filing moves us one step closer to providing a potential new treatment for metastatic breast cancer patients," said Patrick Soon-Shiong, M.D., Chairman, President and Chief Executive Officer of American Pharmaceutical Partners. "By meeting this important milestone our clinical development plan for Abraxane in breast cancer remains on track. With this acceptance we are now aggressively expanding our clinical development program to pursue indications in other malignancies such as non-small cell lung cancer and ovarian cancer, as well as combination therapies of Abraxane with other chemotherapeutic agents."
The filing of the NDA is based primarily upon the pivotal randomized controlled Phase III trial that compared the safety and efficacy of 260 mg/m2 of Abraxane to 175 mg/m2 of Taxol administered every three weeks in 460 patients with metastatic breast cancer. The Phase III trial demonstrated that Abraxane resulted in an almost doubling of the response rate and a prolongation of time to tumor progression in first and second line patients with metastatic breast cancer.
ABI and APP are strategic partners in the development, manufacture and marketing of Abraxane. ABI is responsible for the clinical development and registration of Abraxane. APP has licensed the exclusive North American manufacturing and marketing rights for Abraxane.
About Breast Cancer
According to the American Cancer Society (ACS), while early
detection efforts have decreased mortality rates, in 2004 an
estimated 215,990 women are expected to be diagnosed with breast
cancer that had already spread. Breast cancer is still the leading
overall cause of death in women between the ages of 20 and 59, with
40,110 deaths estimated in 2004. One of every three cancers
diagnosed in the United States is breast cancer; excluding skin
cancer, it's the most common cancer among women.
About the Companies
American BioScience, Inc. is a privately held
biotechnology company focused on the discovery, development and
delivery of next-generation therapeutic moieties including
biologically active molecules already existing within the human
biological system, for the treatment of life-threatening diseases.
American Pharmaceutical Partners, Inc. is a majority owned
subsidiary of American BioScience, Inc.
American Pharmaceutical Partners, Inc. is a
specialty drug company that develops, manufactures and markets
injectable pharmaceutical products, focusing on the oncology,
anti-infective and critical care markets. APP has acquired the
exclusive North American rights to manufacture and market Abraxane,
a proprietary nanoparticle injectable oncology product that has
completed Phase III clinical trials for metastatic breast cancer
and for which the FDA has granted "Fast Track" designation. The NDA
submission has commenced and the submission is now ongoing. The
company believes that it has established the only commercial scale
protein-engineered nanoparticle manufacturing capability in the
United States.
For more information, visit APP's website at
www.appdrugs.com.
Taxol is a registered trademark of Bristol-Myers Squibb Company.
SOURCE: American Pharmaceutical Partners, Inc.
Related Articles:
Abraxane American Pharmaceutical Partners, Inc. / American Bioscience, Inc. - Treatment for Metastatic Breast Cancer - January 7, 2005
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