Acusphere, Inc. (NASDAQ: ACUS) today announced that the Cardiovascular
and Renal Drugs Advisory Committee of the U.S. Food and Drug
Administration advised that the diagnostic benefit of contrast
enhancement using Acusphere’s ImagifyTM (Perflubutane Polymer
Microspheres) for Injectable Suspension is not sufficient to justify the
risks associated with the product. The vote was sixteen against, one in
favor and one abstention. The Committee also discussed concerns that
they would like addressed to support approval of the product for the
detection of coronary artery disease.
“We appreciate the support Imagify has received from a wide variety of
cardiologists, who are eager for FDA to enable them to use the drug in
their practices to improve accessibility, reduce costs and avoid
exposure to radiation,” said Sherri C. Oberg, President and CEO,
Acusphere. “We continue to believe in Imagify for its intended purpose
and will work with FDA through the completion of the review process to
determine what additional information might be required for approval.”
The Advisory Committee’s recommendations, while not binding, will be
considered by the FDA in its review of the New Drug Application (NDA) of
Imagify. The expected FDA target action date for Imagify under the
Prescription Drug User Fee Act (PDUFA) is February 28, 2009.
Conference Call
Acusphere plans to hold a conference call with investors tomorrow,
Thursday, December 11, 2008, commencing at 8:30 am (Eastern Time). The
conference call will cover the Advisory Committee meeting, and will be
led by Sherri C. Oberg, President and Chief Executive Officer and
Lawrence A. Gyenes, Senior Vice President and Chief Financial Officer.
These Acusphere representatives will also be available for investor
questions. The conference may be heard live via the investor relations
section of the Company's website at www.acusphere.com
or by dialing 1-800-299-7635, or internationally 1-617-786-2901 using
the confirmation code: 52594832. After the conference call, a replay of
the call webcast will be made available via the Company's web site and a
telephone replay will be available through January 11, 2009, by dialing
1-888-286-8010, or internationally 1-617-801-6888, using the
confirmation code: 50372331.
About ImagifyTM
ImagifyTM (Perflubutane Polymer Microspheres) for Injectable
Suspension, is an investigational new drug developed to assess perfusion
using ultrasound (or echocardiography) for the detection of coronary
artery disease.