Acusphere Inc. Reaches Special Protocol Assessment Agreement with FDA for Imagify™ Phase 3 Placebo-Controlled Trial

Acusphere, Inc. (ACUS), a specialty pharmaceutical company, today announced that it had reached an agreement with the U.S. Food & Drug Administration regarding the design of a new Phase 3 study of the company's lead product candidate, Imagify™ Perflubutane Polymer Microspheres for Injectable Suspension. As previously announced, this new study, designed under the Special Protocol Assessment process, will compare stress ultrasound with Imagify to stress ultrasound without Imagify for the detection of coronary artery disease. Said Sherri C. Oberg, President and Chief Executive Officer, “We are delighted to have reached agreement with FDA on the design for a new Phase 3 trial for Imagify under the SPA Process. This is a critical milestone for Acusphere, and one that may reduce the level of risk for potential partners. We believe that this trial design will help provide clear evidence of Imagify's superiority over stress ultrasound because it enables myocardial perfusion assessment, a potential $2 billion market in the U.S. alone, and one that is growing. We continue to believe strongly in Imagify's potential for the condition proposed, and we remain committed to realizing that opportunity for the benefit of Acusphere and its shareholders.” She added, “We believe that this accomplishment, together with our continued progress in moving Imagify forward in the European regulatory process, will enable us to approach a wider range of potential partners, in the U.S. and abroad, in a significantly more appealing position. There are few new cardiology drugs that address markets of this size, and we feel that having an agreed-upon trial design for a new Phase 3 trial creates an improved opportunity for the right company.”