Abraxis BioScience, Inc. (NSDQ: ABII) received SFDA approval for ABRAXANE® Paclitaxel for Injection (Albumin Bound) as a breast cancer treatment. The indication was limited to use following failure of standard chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. The approval was based on trials conducted in the US and in China. Currently, Abraxis is conducting trials of ABRAXANE as a first-line chemotherapy for metastatic breast cancer.

ABRAXANE is a protein-bound chemotherapy, combining paclitaxel and albumin to deliver the drug. Because the delivery mechanism does not require solvents, a 49% higher dose of the active ingredient, paclitaxel (Taxol®), can be given without causing safety issues. In the China Phase III trial, ABRAXANE almost doubled the overall tumor response rate compared to solvent-based paclitaxel (54% vs. 29%), prolonged time to tumor progression by 26% and improved overall survival. These results were more positive than the data from the US trials.

In the Asia-Pacific region, ABRAXANE was approved in India in November 2007 and in Korea in April 2008. ABRAXANE is under regulatory review in Australia and Russia.

In the US, ABRAXANE is marketed under a co-promotion agreement between Abraxis and AstraZeneca (NYSE: AZN). There was no announcement about Abraxis’ distribution plans for ABRAXANE in China. Abraxis has not previously had a presence in the China pharmaceutical market.