Abraxis Files for European Approval

0

Los Angeles-based biotech company Abraxis BioScience Inc. reports that the European Medicines Agency has accepted for review the company’s application to market its Abraxane drug for the treatment of breast cancer.

The typical EMEA review period for this centralized procedure is roughly one year. Abraxane was approved in the United States in 2005 and in Canada this June.

“This submission to the EMEA marks an important milestone in our ongoing effort toward the global development and approval of Abraxane,” said Abraxis Chief Executive Patrick Soon-Shiong in a statement. In conjunction with European filing, Abraxis announced it would seek a global commercialization partner for the drug. The company this summer launched a U.S. co-promotion deal with London-based drug giant AstraZeneca Plc.

Abraxis said that it plans to file for regulatory approval in China, Japan, Korea, Taiwan, Australia, Turkey and Russia, among other countries.

Abraxane attaches its cancer treatment to a nano-sized protein particle, “fooling” cancers cells into bonding with it. However, Abraxane sales have been performing below expectations for such the drug, with second quarter sales of $36.3 million, between $4 million and $10 million lower than analysts’ projections.

No posts to display