AbraxaneTreatment for Breast Cancer, Non-Small Cell Lung Cancer, Pancreatic Cancer
American 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.
Posted: May 2004
- FDA Approves Abraxane for Late-Stage Pancreatic Cancer - September 6, 2013
- FDA Approves Abraxane for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer - October 12, 2012
- Abraxane American Pharmaceutical Partners, Inc. / American Bioscience, Inc. - Treatment for Metastatic Breast Cancer - January 7, 2005
- American Pharmaceutical Partners and American BioScience Announce Filing of a New Drug Application for FDA Approval of Abraxane for the Treatment of Metastatic Breast Cancer - March 8, 2004