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FOR IMMEDIATE RELEASE
Acusphere, Inc. Reports Q3 2007
Financial Results and Business Highlights
WATERTOWN, Mass., November 8, 2007 Acusphere, Inc. (NASDAQ: ACUS) today reported financial results for the third quarter ended September 30, 2007 and commented on its business and progress. The Company is moving aggressively to file its planned New Drug Application (NDA) submission for its lead product candidate, ImagifyTM (Perflubutane Polymer Microspheres) for Injectable Suspension, which is planned for early in 2008. Imagify is a Perfusion Stress Echo imaging agent for use in detecting coronary artery disease.
Began focused effort on potential partnership discussions for Imagify and continue extensive dialogue with a wide range of parties
Successfully completed Chemistry Manufacturing and Controls (CMC) meeting with FDA as part of continued push for Imagify NDA filing preparation
Appointed Chief Financial Officer with extensive experience
Imagifys Phase 3 clinical results were presented at the prestigious American Heart Association meeting
Acuspheres key current priorities are:
Preparing the regulatory submissions for Imagify
Continuing active potential partnership discussions for Imagify and a potential Abraxane® bioequivalent
The Company continues to focus on the steps necessary to submit an NDA for Imagify and support the Marketing Authorization Application (MAA) filing in Europe by Nycomed, its European partner. In addition to preparing the clinical sections of the NDA, Acusphere is working to qualify its commercial manufacturing facility for Imagify, including aseptic validation, process performance qualification and continued product stability testing. The Company plans to complete these qualification steps in time to support the NDA submission in early 2008. In addition, the Company announced during the third quarter that it was actively engaged in wide-ranging partnership discussions with respect to Imagify, and those discussions are now moving into a phase where proposals are being received.
The following information was filed by Acusphere Inc (ACUS) on Thursday, November 8, 2007 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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