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news.Acusphere has reported that its product candidate has a comparable pharmacokinetic profile to the breast cancer drug Abraxane based upon human data available in publications on each drug.
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Acusphere plans to make changes to its drug, AI-850, 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.
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 II and III human clinical trials are usually not required.
Sherri Oberg, president and CEO of Acusphere, said: “Our hydrophobic drug delivery system 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.”