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.
