Acusphere Announces Change In Imagify Regulatory Strategy and Deferral of Near-Term Contractual Cash Payments
February 17 2009 - 3:01PM
Business Wire
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. These actions will
carry us into June 2009 at our current burn rate and, together with
discussions already in progress and other cost reduction
initiatives, could allow us to explore strategic partnerships and
financing alternatives following the receipt of the FDA response to
our proposed amendment."
About Acusphere, Inc.
Acusphere (OTCBB: ACUS) 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, filed in June 2008 and amended in February 2009. 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. For more information about Acusphere
visit the Company's web site at www.acusphere.com.
"Acusphere" and "Imagify" are trademarks of Acusphere, Inc.
Forward-looking Statements
The above press release contains forward-looking statements
which are made pursuant to the safe harbor provisions of Section
21E of the Securities Exchange Act of 1934, including statements
regarding, the NDA submission for Imagify and likelihood of
regulatory approval and the commercial opportunity for Imagify.
There can be no assurance that Imagify will be approved for the
indication the Company is seeking, or at all. The Company's actual
results may differ materially from those anticipated in these
forward-looking statements based upon a number of factors,
including anticipated operating losses and existing capital
obligations, uncertainties associated with research, development,
testing and related regulatory approvals, including uncertainties
regarding regulatory evaluation of the Company's statistical
analysis plan and clinical trial results and uncertainties
regarding the potential effects of not achieving clinical
endpoints, limited time to date for the Company to review the
details of the clinical trial results, capital needs and
uncertainty of additional financing, uncertainties regarding the
cost, timing and ultimate success of the qualification of the
Company's commercial manufacturing facility in accordance with
applicable regulatory requirements, complex manufacturing, high
quality requirements, lack of commercial manufacturing experience,
dependence on third-party manufacturers, suppliers and
collaborators, uncertainties associated with intellectual property,
competition, loss of key personnel, uncertainties associated with
market acceptance and adequacy of reimbursement, technological
change and government regulation, and other risks and challenges
detailed in the Company's filings with the U.S. Securities and
Exchange Commission, including the Company's Annual Report on Form
10-K for the year ended December 31, 2007 and its Form 10-Q for the
quarter ended September 30, 2008. Readers are cautioned not to
place undue reliance on any forward-looking statements, which speak
only as of the date of this press release. The Company undertakes
no obligation to publicly release the results of any revisions to
these forward-looking statements that may be made to reflect events
or circumstances that occur after the date of this press release or
to reflect the occurrence of unanticipated events.
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