Abraxis BioScience Receives a Positive Opinion in Europe from the CHMP for the Approval of ABRAXANE for the Treatment of Metastatic Breast Cancer.

The Company Begins Establishing Its European Infrastructure to Prepare for the Launch of ABRAXANE in Europe

LOS ANGELES -- Abraxis BioScience, Inc. (NASDAQ:ABBI), an integrated, global biopharmaceutical company, today announced that ABRAXANE([R]) powder for suspension for infusion (an albumin-bound nanoparticle formulation of paclitaxel), has received a positive opinion in favor of approval from the European Committee for Human Medicinal Products (CHMP) for the treatment of metastatic breast cancer in women who have failed therapy in the first-line setting. The CHMP positive opinion was based on the clinical trial data that supported the approval of ABRAXANE in the United States and Canada. In that trial, ABRAXANE demonstrated significant superiority in the clinical endpoints of response rate, progression free survival and survival when compared with Taxol([R]) in the proposed indication in metastatic breast cancer.

"We are pleased that the CHMP has recommended approval of ABRAXANE for the treatment of metastatic breast cancer and look forward to receiving the final approval over the next few months and establishing our presence in Europe," said Patrick Soon-Shiong, M.D., chairman and chief executive officer of Abraxis BioScience. "More importantly, we believe this positive opinion is an important step in offering women diagnosed with breast cancer across Europe a more effective, convenient and well-tolerated alternative to solvent-based formulations of paclitaxel."

The positive opinion from the full scientific panel was based on the review of a marketing authorization application (MAA) using the centralized registration procedure. Abraxis BioScience has now begun the process of establishing a European infrastructure for the commercialization of ABRAXANE across Europe. The launch of ABRAXANE in Europe by Abraxis will initially focus on the United Kingdom, France, Spain, Italy and Germany.

The positive opinion from the CHMP is the final step before formal approval to market ABRAXANE in Europe. A formal decision by the European Commission on marketing authorization is expected within the next three to four months.

About ABRAXANE

The U.S. Food and Drug Administration approved ABRAXANE([R]) for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in January 2005 for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. The most serious adverse events associated with ABRAXANE in the randomized metastatic breast cancer ...