Company Watch

Biocon and Abraxis announce approval of Abraxane in India

Our News Bureau
Bangalore, Los Angeles

Biocon and Abraxis BioScience, an integrated global biopharmaceutical company, have announced the approval by the country's Drug Controller General to market Abraxane for injectable suspension (paclitaxel protein-bound particles) in India for the treatment of breast cancer. Commercial introduction of Abraxane in the Indian market is expected in 2008, following the completion of the appropriate importation certifications. "The approval of Abraxane in India is an important step in providing access to the NAB (nanoparticle albumin bound) technology globally," said Patrick Soon-Shiong, Managing Director, Chairman and Chief Executive Officer of Abraxis. "In partnership with Biocon, we are excited to offer physicians in India this important advance in the treatment of breast cancer."

In August 2007, Biocon and Abraxis had announced an agreement for the commercialisation of Abraxane in India by Biocon. Under the terms of the agreement, Biocon will have the right to market Abraxane in India, Pakistan, Bangladesh, Sri Lanka, the United Arab Emirates, Saudi Arabia, Kuwait and certain other South Asian and Persian Gulf countries. Abraxis will be initiating a worldwide head-to-head phase III registration trial, comparing weekly Abraxane to every three week Taxotere for the treatment of first-line metastatic breast cancer, as well as phase III trials for the treatment of non-small cell lung cancer and melanoma. Abraxane is currently under active review in Australia, Russia, China and the European Union by their respective regulatory agencies.

Kiran Mazumdar Shaw, Chairman and Managing Director, Biocon, said, "This is a significant step for Biocon's innovation led oncotherapeutics division in our endeavour to bring new therapeutics for Indian cancer patients. There is a huge need for Abraxane in the treatment of breast cancer in the country and we look forward to attaining market leadership in this segment." Biocon's oncotherapeutics portfolio has already seen the successful launch of its proprietary antibody, BIOMAb EGFR for the treatment of head and neck cancers. The approval of Abraxane in India was based on the clinical trial data that was the basis of approval in the United States. In that trial, Abraxane demonstrated a superior response rate with an almost doubling of the reconciled target lesion response rate when compared with Taxol in a prospectively randomised trial of 460 patients with metastatic breast cancer.

Abraxane uses albumin, a human protein, to deliver the active ingredient paclitaxel. Unlike other chemotherapy treatments, Abraxane does not contain chemical solvents, which eliminates the need for pre-medication with steroids or antihistamines often needed to prevent the toxic side effects associated with solvents. Abraxane was developed by Abraxis and is marketed in the US under a co-promotion agreement between Abraxis and AstraZeneca Pharmaceutical.