AI-700, currently in phase III clinical trials, is Acusphere’s leading product candidate. The commercial scale batch, produced at the company’s commercial manufacturing facility in Tewksbury, Massachusetts, met all of its pre-defined target specifications.
For purposes of its phase III clinical trials, Acusphere produced AI-700 at a third-party site, which was suitable for production of AI-700 clinical trial material but inadequate for commercial production.
The next steps in development are aseptic qualification of the facility, product stability testing and completion of other validation activities under current good manufacturing practices (cGMPs). Data from the production of AI-700 under cGMPs is intended to be part of the Company’s new drug application (NDA) submission for AI-700, which is currently scheduled for the first half of 2007.
“We are pleased to have achieved this key milestone which allows us to maintain our NDA submission timeline for AI-700,” stated Sherri Oberg, president and CEO of Acusphere.