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news.Abraxis BioScience, a biotechnology company, has entered into an agreement with AstraZeneca, under which, subject to approval by the board of directors of Abraxis, the company would re-acquire the exclusive rights to market Abraxane in the US.
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Abraxis has developed an extensive clinical program that the company believes will form the basis for new indications for Abraxane as well as other product candidates for which the company’s nab-technology platform is deployed.
This program includes eight Phase III clinical trials, for which five protocols have been reviewed by the FDA for study design, 65 investigator-initiated Phase II clinical trials and 16 Phase I studies.
Patrick Soon-Shiong, chairman and CEO of Abraxis BioScience, said: “In multiple tumor types, the Phase II data for Abraxane in breast, lung, melanoma and pancreatic cancer has met pre-specified endpoints resulting in the FDA and Japanese regulatory authorities agreeing to the company proceeding with pivotal trials of Abraxane in a number of new indications in 2009. We also anticipate initiating two Phase III clinical trials with our proprietary candidate nab-docetaxel.”