TEWKSBURY, Mass, June 24, 2009 -- 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 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.
Contact:
Acusphere, Inc.
Sherri Oberg,
617-925-3444
IR@acusphere.com