Acusphere, Inc. (ACUS.PK) today announced that co-founder and CEO,
Sherri C. Oberg, will assume a new role as Executive Chair, working 20%
of her time. Ms. Oberg will retain the title of President but effective
December 16, 2009, she will resign as Chief Executive Officer.
Commensurate with her new responsibilities, her salary will be reduced
to 20% of its current level. Acusphere’s current focus is to work with
the FDA to design the new clinical trial required for U.S. regulatory
approval of the Company’s lead product candidate, ImagifyTM
(Perflubutane Polymer Microspheres) for Injectable Suspension, a
cardiovascular drug for the detection of coronary artery disease, and to
work with regulatory agencies in Europe to determine what additional
work must be completed before filing the Marketing Authorization
Application (“MAA”) to support Imagify in that market. Since most of
this work is presently underway utilizing third parties, Ms. Oberg
recommended changing her role as a cost-saving measure for the Company.
“In today’s environment, reducing health care costs is a national
priority. We believe that Imagify has the potential to save billions of
dollars in cardiac screening costs while improving the quality of health
care by eliminating the radiation exposure of nuclear stress testing,
which is associated with a 1 in 1000 cancer death rate from a single
procedure, “ said Ms. Oberg. “I look forward to working with FDA and the
European regulatory authorities to complete the remaining steps required
for approval so that Imagify can reach the marketplace and contribute to
improved patient care, faster and less expensively.”
Ms. Oberg will continue to oversee the regulatory discussions as well as
strategic discussions with potential corporate partners. The Company now
expects its cash resources to extend into the third quarter of 2010.
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. In the complete response
letter received in February 2009, FDA noted that additional clinical
trial work would need to be completed in advance of regulatory approval.
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 (www.acusphere.com).
Forward-looking Statements
The above press release contains forward-looking statements,
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. The
Company notes that effective as of March 3, 2009, pursuant to a Form 15
filing made with the SEC, it is not currently required to file periodic
reports with the SEC, including annual reports on Form 10-K, quarterly
reports on Form 10-Q and current reports on Form 8-K. 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.