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American Pharmaceutical Partners Announces Presentation of ABRAXANE(TM) Survival Data at 22nd Annual Miami Breast Cancer Conference

Posted on: Friday, 25 February 2005, 09:00 CST

SCHAUMBURG, Ill., Feb. 25 /PRNewswire-FirstCall/ -- American Pharmaceutical Partners, Inc. today announced that the pivotal Phase III clinical study of ABRAXANE(TM) for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in patients with metastatic breast cancer demonstrated a statistically significant improvement in survival in second-line patients. The data were presented at the 22nd Annual Miami Breast Cancer Conference in Miami, FL, by Edith Perez, M.D., Professor of Medicine, Mayo Clinic College of Medicine, Chair Breast Committee, North Central Cancer Treatment Group. Dr. Perez's presentation of new anti-tubulin agents included for the first time an initial analysis of survival data from the prospectively randomized trial of 460 patients with metastatic breast cancer.

The study population included patients who were previously untreated and those who were previously treated (second-line or greater-line therapy) for metastatic breast cancer. In the overall patient population, median survival for those patients receiving ABRAXANE was 10 weeks longer (65.0 weeks v. 55.7 weeks) than for patients receiving Taxol but this difference did not reach statistical significance. However there was a significant prolongation in survival (p=0.016) in patients receiving ABRAXANE in the second-line or greater setting as compared to those receiving Taxol (56.4 weeks vs. 46.7 weeks). In this group, there was a 29% reduction in the risk of death (i.e., hazard ratio of 0.71) for patients who received ABRAXANE compared to those who received Taxol.

ABRAXANE consists only of albumin-bound paclitaxel nanoparticles and no toxic solvents. As previously reported, in the Phase III clinical study, ABRAXANE demonstrated a superior response rate with an almost doubling of the reconciled target lesion response rate when compared with the solvent-based Taxol(R). Because it contains no toxic solvents, this next-generation taxane product enables the administration of 50% more chemotherapy with a well-tolerated safety profile, requires no premedication to prevent hypersensitivity reactions and can be given over 30 minutes using standard IV tubing. The Phase III study was designed to compare ABRAXANE(TM) at a dose of 260 mg/m2 given as a 30-minute infusion without premedication to paclitaxel injection (Taxol(R)) at 175 mg/m2 given as a 3-hour infusion with standard steroid and antihistamine premedication.

ABRAXANE(TM) was launched on February 7, 2005 by Abraxis Oncology, the proprietary division of APP after having received FDA approval in January. ABRAXANE is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.

About American Pharmaceutical Partners

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. Abraxis Oncology, the proprietary division of APP, is devoted entirely to developing and promoting innovative, next-generation cancer therapies such as ABRAXANE(TM), recently launched for the treatment of metastatic breast cancer. For more information, visit APP's website at http://www.appdrugs.com/ and http://www.abraxisoncology.com/.

This press release contains forward-looking statements within the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. All statements included or incorporated by reference in this press release, other than statements that are purely historical, are forward-looking statements. The words "may,""will,""should,""could,""expect,""plan,""anticipate,""believe,""estimate,""predict,""continue," and similar expressions identify forward-looking statements. Forward-looking statements also include the assumptions underlying or relating to any forward-looking statements.

Because these forward-looking statements involve risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include, without limitation, the timing of and costs associated with the ongoing launch of ABRAXANE(TM), the market adoption and demand of ABRAXANE, that the actual results achieved in further Phase II and III trials for ABRAXANE may or may not be consistent with results achieved to date, the difficulty in predicting the timing or outcome of other product research and development efforts, potential product characteristics and indications, marketing approvals and launches of other products, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing, the availability and pricing of ingredients used in the manufacture of pharmaceutical products, the ability to successfully manufacture products in a time-sensitive and cost effective manner, the acceptance and demand of new pharmaceutical products, the impact of patents and other proprietary rights held by competitors and other third parties. Additional relevant information concerning risks can be found in the Company's Form 10-K for the year ended December 31, 2003 and other documents filed by the Company with the Securities and Exchange Commission.

The forward-looking statements in this press release reflect the Company's judgment as of the date of this press release. The Company disclaims any intent or obligation to update these forward-looking statements.

Taxol is a registered trademark of Bristol-Myers Squibb Company.

American Pharmaceutical Partners, Inc.

CONTACT: Nicole Williams, Executive Vice President & CFO of AmericanPharmaceutical Partners, Inc., +1-847-969-2700; or Rob Whetstone or RobertJaffe, both of PondelWilkinson Inc., +1-310-279-5963, for AmericanPharmaceutical Partners, Inc.

Web site: http://www.abraxisoncology.com/

Web site: http://www.appdrugs.com/

Source: PRNewswire-FirstCall

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