Acusphere, Inc. Announces Change in Management
TEWKSBURY, Mass., Dec 15, 2009 (BUSINESS WIRE) -- 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).
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.
SOURCE: Acusphere, Inc.
Investors:Acusphere, Inc.Kelley Wharff, [email protected] Business Wire 2009