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New Drug Application for Abraxane Filed, Treatment of Metastatic Breast Cancer

SCHAUMBURG, Ill., March 8 /PRNewswire-FirstCall/ -- American Pharmaceutical Partners, Inc. (APP) (Nasdaq: APPX - News) and American BioScience, Inc. (ABI) today announced that ABI has completed the filing of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ABRAXANE(TM), for the treatment of metastatic breast cancer. Using proprietary nanoparticle technology, ABRAXANE combines the active drug paclitaxel with a natural protein called albumin into a nanoparticle 1/100th the size of a red blood cell, avoiding the need for any solvent. ABRAXANE is the first solvent-free nanoparticle albumin-bound chemotherapeutic, and may potentially exploit an inherent pathway for albumin receptor-mediated transport of drugs across endothelial cell walls of tumor neovasculature.

The NDA was submitted under the FDA's Fast Track designation, which was designed to facilitate the development of drugs for which there is an unmet medical need. As part of the NDA filing, ABI has requested FDA to consider the application for priority review designation, which if so designated, could potentially accelerate the approval of ABRAXANE. The filing of the NDA is based upon supportive Phase I and II clinical trials of ABRAXANE and a 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. In addition, the study confirmed that ABRAXANE could be administered safely over 30 minutes without the need for steroid premedication.

This filing culminates a decade of preclinical and clinical research of ABRAXANE as the first biologically interactive nanoparticle chemotherapy. Preclinical studies demonstrated greater anti-tumor activity and higher intra- tumoral concentration of ABRAXANE and these findings were predictive of the Phase III clinical results. Potential explanations for these findings are provided by ongoing mechanistic studies which suggest that the increased anti- tumor activity and increased intra-tumoral concentration of the drug may be due, in part, to albumin-mediated receptor transport of the drug across the blood vessel wall into the tumor.

According to Patrick Soon-Shiong, M.D., Chairman, President and Chief Executive Officer of American Pharmaceutical Partners, "Targeting endothelial cell transport is a novel approach to increasing drug concentration in the tumor and provides the opportunity to exploit a natural biological pathway the malignant cell inherently uses to supply itself nutrients and energy for rapid growth. Using this mechanism, the target would be shifted from the tumor cells themselves to the specific albumin receptor on the blood vessel wall of the tumor neovasculature. ABRAXANE represents the first example of the albumin-bound nanoparticle technology platform which may have the potential to exploit this natural biological pathway."

ABRAXANE was originally developed with the goal of addressing the toxicities associated with the solvents Cremophor-EL and alcohol, used in TAXOL. These toxicities required the need to premedicate patients with corticosteroids; required extended infusion times of TAXOL; limited the dose of TAXOL that could be administered; and, necessitated the use of specialized intravenous tubing sets to avoid leaching of plasticizers into the patient.

About Breast Cancer
According to the American Cancer Society (ACS), while early detection efforts have decreased mortality rates, in 2003 more than 200,000 women were 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 almost 41,000 deaths associated with breast cancer each year. One of every three cancers diagnosed in the United States is breast cancer; excluding skin cancer, it's the most common cancer among women.

Source: American Pharmaceutical Partners, Inc. and American BioScience, Inc. (ABI)

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