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Jul 29, 2010

New Zealand and Japan Sanction Abraxis’ Albumin-Bound Paclitaxel for Breast Cancer Therapy

  • Abraxis BioScience reported regulatory approval of Abraxane® in New Zealand for the treatment of metastatic breast cancer after failure of anthracylcine therapy. The latest approval for the albumin-bound paclitaxel formulation follows on from Japanese clearance, which was granted just a few days ago. Both approvals spell good news for Celgene, which in June announced an agreement to acquire Abraxis in a cash and shares deal that values the firm at some $2.9 billion.

    Abraxane was developed by Abraxis using its nanparticle albumin-bound nab™ technology platform and will be distributed in New Zealand by marketing partner Specialised Therapeutics once reimbursement approval has been received by the country’s pharmaceutical reimbursement authority. In Japan the drug will be marketed by Otsuka’s Taiho Pharmaceutical business.

    Abraxane was approved in the U.S. in January 2005 and is now approved in 41 countries including those in the EU, Abraxis notes. The drug is the company’s flagship product and is also undergoing Phase II/III development for the treatment of breast cancer including metastatic and taxane-refactory disease as well as advanced lung cancer, malignant melanoma, and advanced pancreatic cancer.

    Abraxis is exploiting its technology for the development of nab-based formulation of doctaxel and rapamycin, which are in Phase II and Phase I development, respectively. A nab-formulated Hsp90 inhibitor and a dual microtubule/topoisomerase-1 inhibitor are also in preclinical development.

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