Acusphere to Develop Potential Abraxane(R) Bioequivalent
Friday November 2, 9:03 am ET
Reformulation of paclitaxel offers partnership opportunities and faster track to commercialization
WATERTOWN, Mass.--(BUSINESS WIRE)--Acusphere, Inc. (NASDAQ: ACUS - News) announced today that its product candidate AI-850 has a comparable pharmocokinetic profile to the breast cancer drug Abraxane® based upon human data available in publications on each drug. AI-850 is Acusphere’s patented formulation of paclitaxel, the active ingredient in Abraxane. Drug product candidates that are confirmed to have equivalent pharmacokinetics in a human study may be eligible for regulatory approval as a bioequivalent, with an accelerated development timeline, since Phase 2 and 3 human clinical trials are usually not required. Abraxane for Injectable Suspension, which is marketed under a co-promotion agreement between Abraxis BioScience, Inc. and AstraZeneca, generated $150 million in revenues in the six months ended June 30, 2007, and is projected by some analysts to reach revenues of $1 billion by 2013.
Acusphere plans to make changes to the AI-850 formulation that will make it a more suitable commercial formulation and plans to work with a partner to bring this improved formulation into development for approval as a bioequivalent to Abraxane. The Company has commenced discussions with potential partners to move this program forward.
Sherri C. Oberg, Acusphere’s President and CEO, said, “Our Hydrophobic Drug Delivery System (HDDS) technology has enabled us to engineer a drug candidate that has comparable pharmacokinetics to one of the fastest growing cancer drugs. We are in active discussions with potential partners on a strategy that could lead to quicker commercialization options for this important program. This program will have no impact on our previously-communicated financial guidance for operating expenses.”
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