abraxane aap

First Biologically Interactive Protein Nanoparticle Chemotherapy Resulted inAlmost Doubling of Response Rate and Prolongation of Time to Tumor Progressionin Women With Metastatic Breast Cancer

SCHAUMBURG, Ill., March 8, 2004 -- American Pharmaceutical Partners, Inc abraxane aap. (APP)and American BioScience, Inc abraxane aap. (ABI) today announced that ABI has completed thefiling of a New Drug Application (NDA) to the U.S abraxane aap. Food and Drug Administration(FDA) for Abraxane, for the treatment of metastatic breast cancer abraxane aap. Using proprietarynanoparticle technology, Abraxane combines the active drug paclitaxel with anatural protein called albumin into a nanoparticle 1/100th the size of a redblood cell, avoiding the need for any solvent abraxane aap. Abraxane is the first solvent-freenanoparticle albumin-bound chemotherapeutic, and may potentially exploit aninherent pathway for albumin receptor-mediated transport of drugs across endothelialcell walls of tumor neovasculature.

The NDA was submitted under the FDA's Fast Track designation, which was designedto facilitate the development of drugs for which there is an unmet medical need abraxane aap. As part of the NDA filing, ABI has requested FDA to consider the applicationfor priority review designation, which if so designated, could potentially acceleratethe approval of Abraxane abraxane aap. The filing of the NDA is based upon supportive PhaseI and II clinical trials of Abraxane and a pivotal randomized controlled PhaseIII trial that compared the safety and efficacy of 260 mg/m2 of Abraxane to175 mg/m2 of Taxol(R) administered every three weeks in 460 patients with metastaticbreast cancer abraxane aap. The Phase III trial demonstrated that Abraxane resulted in analmost doubling of the response rate and a prolongation of time to tumor progressionin first and second line patients with metastatic breast cancer abraxane aap. In addition,the study confirmed that Abraxane could be administered safely over 30 minuteswithout the need for steroid premedication.

This filing culminates a decade of preclinical and clinical research of Abraxaneas the first biologically interactive nanoparticle chemotherapy abraxane aap. Preclinicalstudies demonstrated greater anti-tumor activity and higher intra- tumoral concentrationof Abraxane and these findings were predictive of the Phase III clinical results abraxane aap. Potential explanations for these findings are provided by ongoing mechanisticstudies which suggest that the increased anti- tumor activity and increasedintra-tumoral concentration of the drug may be due, in part, to albumin-mediatedreceptor transport of the drug across the blood vessel wall into the tumor.

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

Abraxane was originally developed with the goal of addressing the toxicitiesassociated with the solvents Cremophor-EL and alcohol, used in Taxol abraxane aap. Thesetoxicities required the need to premedicate patients with corticosteroids; requiredextended infusion times of Taxol; limited the dose of Taxol that could be administered;and, necessitated the use of specialized intravenous tubing sets to avoid leachingof plasticizers into the patient.

ABI and APP are strategic partners in the development, manufacture and marketingof Abraxane abraxane aap. ABI is responsible for the clinical development and registrationof Abraxane abraxane aap. APP has licensed the exclusive North American manufacturing andmarketing rights for Abraxane abraxane aap. APP has taken a number of steps in preparingfor the launch of Abraxane, including forming a proprietary drug division, AbraxisOncology, and hiring a seasoned sales and marketing and medical affairs teamwith extensive experience in oncology abraxane aap. APP has made significant strides in buildinga drug sales force and thus far has hired over 50 sales representatives withmajor pharmaceutical oncology experience.

About Breast Cancer
According to the American Cancer Society (ACS), while early detection effortshave decreased mortality rates, in 2003 more than 200,000 women were expectedto be diagnosed with breast cancer that had already spread abraxane aap. Breast cancer isstill the leading overall cause of death in women between the ages of 20 and59, with almost 41,000 deaths associated with breast cancer each year abraxane aap. One ofevery three cancers diagnosed in the United States is breast cancer; excludingskin cancer, it's the most common cancer among women.

About the Companies
American BioScience, Inc abraxane aap. is a privately held biotechnology company focusedon the discovery, development and delivery of next-generation therapeutic moietiesincluding biologically active molecules already existing within the human biologicalsystem, for the treatment of life-threatening diseases abraxane aap. American PharmaceuticalPartners, Inc abraxane aap. is a majority owned subsidiary of American BioScience, Inc.

American Pharmaceutical Partners, Inc abraxane aap. is a specialty drug company that develops,manufactures and markets injectable pharmaceutical products, focusing on theoncology, anti-infective and critical care markets abraxane aap. APP has acquired the exclusiveNorth American rights to manufacture and market Abraxane(TM), a proprietarynanoparticle injectable oncology product that has completed Phase III clinicaltrials for metastatic breast cancer abraxane aap. The company believes that it has establishedthe only commercial scale protein-engineered nanoparticle manufacturing capabilityin the United States.

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