Acusphere, Inc. Announces Amended Terms of Cephalon Agreements
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TEWKSBURY, Mass.--(Business Wire)--
Acusphere, Inc. (ACUS.PK) today announced a $1 million payment by Cephalon, the
cancellation of Cephalon`s $15 million Senior Secured Convertible Note ("Note")
and the amendment of its March and November 2008 License Agreements with
Cephalon for the oncology applications of Acusphere`s Hydrophobic Drug Delivery
System ("HDDS") technology and AI-525, an intravenous formulation of celecoxib.
Under the amended terms of the License Agreements, Cephalon is no longer
obligated to make a $15 million milestone payment or any royalty payments upon
approval of AI-525 and Cephalon will assume primary responsibility for patent
prosecution of licensed technology. As a result of this transaction, Cephalon`s
Pledge and Security Agreement, and Registration Rights Agreement have also been
terminated and Cephalon no longer has a security interest in any of Acusphere`s
assets. Also as a result of this transaction, Cephalon no longer has any rights
related to equity ownership in Acusphere nor any product rights to Imagify
(Perflubutane Polymer Microspheres) for Injectable Suspension, Acusphere`s lead
product candidate.
Acusphere now has global rights to Imagify, a Perfusion Stress Echo imaging
agent for detecting coronary artery disease, the leading cause of death in the
U.S. Targeting a $2 billion potential market in the U.S. alone, Imagify is being
developed to offer a low cost, radiation free alternative to the 7 million
nuclear stress imaging procedures performed each year in the U.S. The Company is
currently seeking a partner for the continued development of Imagify.
Previously, the Company announced that it received in February 2009 a complete
response from the U.S. Food & Drug Administration (FDA) to its New Drug
Application (NDA) for Imagify. FDA`s response stated that additional clinical
work demonstrating Imagify`s performance relative to non-contrast ultrasound
would be required before approval for marketing in the U.S. The amount of time
and funding required to complete the additional clinical work will depend on the
design of the clinical program, which will be developed collaboratively with the
potential partner and FDA. After the $1 million payment from Cephalon, the
Company has approximately $2.8 million in unaudited cash which the Company
expects will fund operations to the fourth quarter of 2009 based on the current
operating plan.
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. 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
qualityrequirements, 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.
Acusphere, Inc.
Sherri Oberg, 617-925-3444
IR@acusphere.com
Copyright Business Wire 2009
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