Biocon & Abraxis to introduce breast cancer drug Abraxane in India

Biocon Limited and Abraxis BioScience Inc will soon launch the breast cancer drug Abraxane in India. Abraxane (paclitaxel protein-bound particles for injectable suspension is an albumin-bound) is indicated for the treatment of breast cancer after failure of combination therapy for metastatic disease or relapse within six months of adjuvant chemotherapy.

Abraxane is now available in India as a single-use 100 mg vial (as a lyophilized powder, to be reconstituted for intravenous administration). It is approved for marketing in 35 countries including USA and Europe, stated Kiran Mazumdar-Shaw, chairman and managing director, Biocon Limited.

Abraxane is a solvent-free chemotherapy treatment option for metastatic breast cancer. Developed by using Abraxis BioScience's proprietary nab technology platform, Abraxane is a protein-bound chemotherapy agent, which combines paclitaxel with albumin, a naturally-occurring human protein, to deliver the drug and eliminates the need for solvents in the administration process. Because solvents are not used for administration, Abraxane allows for the delivery of a 49 per cent higher dose compared to solvent-based paclitaxel (Taxol) without compromising safety and tolerability. In a previous randomized phase III study of metastatic breast cancer patients, Abraxane demonstrated nearly double the overall tumour response rate compared to solvent-based paclitaxel.

Earlier Pharmabiz had reported that in the Asia-Pacific region, Abraxane was approved in India in November 2007 and in Korea in April 2008. Abraxane is under regulatory review by the Therapeutic Goods Administration (TGA) in Australia and by the Federal Authority for Healthcare and Social Development Regulation in Russia for the treatment of breast cancer. In March 2008, the Japanese licensee of Abraxis, Taiho Pharmaceutical Co., filed a New Drug Application (J-NDA) with the Ministry of Health, Labour and Welfare to market Abraxane for the treatment of breast cancer in Japan.

In addition, Abraxis has received approval from the China State Food and Drug Administration to market Abraxane Paclitaxel for injection (Albumin Bound) for the treatment of breast cancer after failure of standard chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.