Monday, July 09, 2012 9:32:29 AM
LEXINGTON, Mass., Jul 09, 2012 (BUSINESS WIRE) -- Acusphere, Inc. (ACUS.PK)
today announced that it had completed the Marketing Authorisation Application
(MAA) dossier for its lead product candidate, Imagify(TM)
(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
(EU). 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), the leading cause of death in Europe and
throughout the world, including the U.S. 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 compelling cost and convenience advantages over
the current standard of care, nuclear stress testing, as well as safety
advantages over nuclear stress testing: 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 European
population is similar to the U.S. population and the prevalence of heart disease
is similar as well (the U.S. addressable market is approximately 10 million
procedures/$2 billion).
Earlier this year, Acusphere closed an $8 million in debt financing with Burrill
& 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 11,428,572
shares of Acusphere common stock, assuming the full $8 million is drawn down.
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