Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated, global biotechnology company, and Specialised Therapeutics Ltd. today announced that MEDSAFE, the New Zealand Medicines and Medical Devices Safety Authority, has approved for marketing ABRAXANE ® (nanoparticle albumin-bound paclitaxel) for the treatment of metastatic breast cancer after failure of anthracycline therapy.
Abraxis BioScience granted exclusive marketing rights to Specialised Therapeutics for ABRAXANE in New Zealand. Specialised Therapeutics will commence distribution upon receiving reimbursement approval of ABRAXANE from the New Zealand pharmaceutical reimbursement authority, Pharmac. ABRAXANE is currently fully reimbursed for “ Metastatic breast cancer after failure of prior therapy” in Australia under the Pharmaceutical Benefits Scheme.
“In the U.S. and Australia ABRAXANE has rapidly become the taxane treatment of choice in its approved indication,” said Patrick Soon-Shiong, M.D., Executive Chairman of Abraxis BioScience. “We are pleased to provide this new treatment option for women in New Zealand with metastatic breast cancer.”
“ABRAXANE offers a safer and more efficacious taxane therapy for New Zealand women with metastatic breast cancer,” said Carlo Montagner, Chief Executive Officer of Specialised Therapeutics. “Discussions with Pharmac will commence shortly and we hope to make ABRAXANE available as soon as an agreement with Pharmac is reached.”With the approval in New Zealand, ABRAXANE is now approved in 41 countries. About ABRAXANE ® ABRAXANE is a solvent-free chemotherapy treatment option for metastatic breast cancer which was developed using Abraxis BioScience’s proprietary nab ® technology platform. This protein-bound chemotherapy agent combines paclitaxel with albumin, a naturally-occurring human protein. By wrapping the albumin around the active drug, ABRAXANE can be administered to patients at higher doses, delivering higher concentrations of paclitaxel to the tumor site than solvent-based paclitaxel. ABRAXANE is currently in various stages of investigation for the treatment of the following cancers: expanded applications for metastatic breast, non-small cell lung, malignant melanoma, pancreatic and gastric. The U.S. Food and Drug Administration approved ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in January 2005 for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. For the full prescribing information for ABRAXANE please visit http://www.abraxane.com. About nab ® -Driven Chemotherapy Abraxis BioScience has developed a proprietary nanoparticle albumin-bound (nab) technology which leverages albumin nanoparticles for the active and targeted delivery of chemotherapeutics to the tumor. This nab-driven chemotherapy provides a new paradigm for penetrating the blood-stroma barrier to reach the tumor cell. The proposed mechanism of delivery of this nab-driven chemotherapy is thought to be by targeting a previously unrecognized tumor-activated, albumin-specific biologic pathway with a nanoshell of the human blood protein albumin. This nano-shuttle system is believed to activate an albumin-specific (Gp60) receptor-mediated transcytosis path through the cell wall of proliferating tumor cells, using caveolin-1 activated caveolar transport. Once in the stromal micro-environment, the albumin-bound drug may be preferentially localized by a second albumin-specific binding protein, SPARC, a protein secreted into the stroma by tumor cells. The resulting collapse of stroma surrounding the tumor cell may thus enhance the delivery of the nab-chemotherapeutic to the intracellular core of the tumor cell itself.