Acusphere Inc. (OTCBB: ACUS) announced today that it has submitted an
amendment to its New Drug Application (NDA) for ImagifyTM
(Perflubutane Polymer Microspheres) for Injectable Suspension. Imagify
is designed for the detection of coronary artery disease, the leading
cause of death in the United States. The NDA was submitted to the U.S.
Food & Drug Administration (FDA) in April 2008 and filed in June 2008.
Imagify is designed to enable ultrasound to compete more effectively
with nuclear stress testing, the leading procedure for detecting
coronary artery disease. It is estimated that more than 10 million
cardiac stress imaging procedures are done each year in the U.S. of
which 6.5 million are conducted with exercise stress and 3.5 million are
conducted with pharmacologic stress. If FDA accepts the submitted
amendment, the Imagify indication will be limited to subsets of patients
undergoing pharmacologic stress techniques. The amended indication is
focused on patients where the risk-to-benefit ratio of Imagify is more
compelling than the broader indication that was originally filed. Since
this is a significant amendment to the NDA for Imagify, it is likely
that the FDA will push back the Prescription Drug User Fee Act (PDUFA)
target date for their complete response letter from February 28, 2009 to
May 31, 2009.
The Company has engaged in discussions to reduce, defer or eliminate
costs to ensure that it can fund its operations beyond the anticipated
PDUFA date of May 31, 2009. The Company also announced today that it had
completed the renegotiation of payment terms under certain intellectual
property agreements. Payments totaling approximately $6.7 million due in
2009 will be reduced to $350,000 immediately, with another $350,000
payable upon a financing of the company, and the remainder due in 2013.
In addition, the Company announced last week that the Board of Directors
elected not to declare a quarterly cash dividend to holders of it 6.5%
convertible exchangeable preferred stock that was otherwise payable on
March 1, 2009, saving an additional $195,000.
Lawrence A. Gyenes, Chief Financial Officer of Acusphere, said, "We are
very pleased to reach these agreements.
