American Pharmaceutical Partners, Inc. (APP), a specialty drug company, and American BioScience, Inc. (ABI), a privately held biotechnology company, 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.