Acusphere, Inc. (ACUS.PK) today announced that it has prepaid its
equipment loans with Oxford Finance Corporation and Massachusetts
Development Finance Agency. These transactions, in combination with the
previously disclosed prepayment in full of General Electric Capital
Corporation debt, represent total debt reduction of $3.8 million. After
such prepayments, the Company has approximately $2.4 million in
unaudited cash which is expected to fund operations to the end of the
third quarter of 2009 based on the current operating plan.
The Company continues to discuss its New Drug Application (NDA) with the
U.S. Food & Drug Administration (FDA) for its lead product candidate,
Imagify™ (Perflubutane Polymer Microspheres) for Injectable Suspension,
a Perfusion Stress Echo imaging agent targeted for use in detecting
coronary artery disease. The Company previously announced that it had
received a complete response from the FDA for Imagify in February 2009,
FDA’s target date under the Prescription Drug User Fee Act (PDUFA). The
response was largely consistent with the feedback received at the
Advisory Committee meeting in December 2008, and discussions that
continued with FDA in January 2009. In general, FDA’s response stated
that additional clinical work would be required to support approval.
Discussions with FDA continue regarding the design of the clinical
program.
About Acusphere, Inc.
Acusphere is a specialty pharmaceutical company that develops new drugs
and improved formulations of existing drugs using its proprietary
microsphere technology. We are focused on developing proprietary drugs
that can offer significant benefits such as improved safety and
efficacy, increased patient compliance, greater ease of use, expanded
indications or reduced cost. Our lead product candidate, ImagifyTM
(Perflubutane Polymer Microspheres) for Injectable Suspension, is a
cardiovascular drug for the detection of coronary artery disease, the
leading cause of death in the United States, for which a New Drug
Application (NDA) was submitted to the U.S. Food & Drug Administration
(FDA) in April 2008 and filed in June 2008. Imagify and the Company's
other product candidates were created using proprietary technology that
enables Acusphere to control the porosity and size of nanoparticles and
microspheres in a versatile manner that allows them to be customized to
address the delivery needs of a variety of drugs.