July 20, 2012 — Acusphere Inc. announced that it had completed the marketing authorization application (MAA) dossier for its lead product candidate, Imagify (perflubutane polymer microspheres) for injectable suspension, and is now starting the process of filing the MAA dossier with the European Medicines Agency (EMA) to support the regulatory review of Imagify in the European Union. The company has also secured an additional $8 million of debt financing this year, following stockholder approval of a reverse stock split in early 2012.
“We are very pleased that we have completed the MAA dossier within the timing we predicted, since starting the submission in Europe marks a major milestone for Acusphere and Imagify,” said Sherri C. Oberg, president and CEO of the company. “With the benefit of our new financing as well as this critical step, we look forward to working with the European rapporteurs through their schedule of reviews in our efforts to bring what we believe is a very promising drug forward into the European marketplace. At the same time, we are ramping up our potential partnership efforts, focused both on the European opportunity as well as global and U.S. markets, so that the timing of those discussions is synchronized with the MAA review process. ”
Imagify is under development as a cardiovascular drug intended for the detection of coronary artery disease (CAD), a leading cause of death throughout the world. It remains the leading development candidate for myocardial perfusion assessment with ultrasound. Acusphere believes that Imagify continues to show promise as a radiation-free test for perfusion assessment, offering cost and convenience advantages over the current standard of care — nuclear stress testing — as well as safety advantages. Each episode of nuclear stress testing delivers a radiation dose equivalent to between 140 and 800 chest X-rays depending upon the radiopharmaceutical used, whereas Imagify is radiation-free. At least 3 million procedures, which translate to a $600 million addressable market for Imagify, occur each year in Europe, based upon existing procedures. Acusphere believes this market could grow significantly since the prevalence of heart disease in the European population is similar to the U.S. population’s (the U.S. addressable market is approximately 10 million procedures, or $2 billion).
Earlier this year, Acusphere closed an $8 million in debt financing with Burrill and Co.’s venture capital group, bringing Burrill’s total investment in Acusphere to $18 million. To date, $3.5 million of the new financing has been received, with the remaining $4.5 million to be provided in additional installments through November 2012, subject only to standard closing conditions. The new debt is convertible at Burrill’s option into 11.4 million shares of Acusphere common stock, assuming the full $8 million is drawn down.
For more information: www.acusphere.com