ImagifyTreatment for Diagnostic
Imagify to be Reviewed at FDA Meeting
Acusphere's Imagify to be Reviewed at FDA Advisory Committee Meeting on December 10, 2008
WATERTOWN, Mass.--(BUSINESS WIRE)--Oct 13, 2008 - Acusphere, Inc. (NASDAQ: ACUS) announced today that the Food and Drug Administration (FDA) has published a Federal Register Notice on the FDA website (www.fda.gov/cder/audiences/acspage/meetings/cvrac_20081210.htm) of a planned public meeting of the Cardiovascular and Renal Drugs Advisory Committee on December 10, 2008. On the agenda for that meeting will be a review of Acusphere's lead product candidate, Imagify (Perflubutane Polymer Microspheres) for Injectable Suspension, proposed for use as an ultrasound imaging agent indicated for patients with stable chest pain being evaluated for inducible ischemia for the detection of coronary artery disease based on assessment of myocardial perfusion and wall motion.
"We are excited about this opportunity to present the case for Imagify's approval by FDA. We believe that there is a significant public health need for a cost-effective, convenient and radiation-free alternative to the 7 million nuclear stress tests done each year in the U.S. to detect coronary artery disease, the leading cause death in the U.S. We hope that the Advisory Committee and FDA will agree with our view that Imagify meets that need," said Sherri C. Oberg, President and CEO of Acusphere.
The Imagify briefing package prepared by the Company will focus on the safety, efficacy and risk-benefits of the procedure. In addition, FDA will prepare briefing materials for the advisory committee. It is the usual practice of FDA to post both the sponsor's and the agency's publicly available briefing materials on the FDA website (www.fda.gov/ohrms/dockets/ac/acmenu.htm) no later than two full business days before the committee meeting.
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, Imagify (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 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 procedures are done each year in the U.S. to detect coronary artery disease, the leading cause of death in the United States. The Company estimates that the potential annual U.S. market opportunity for Imagify exceeds $2 billion. 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.
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 efficacy, safety and tolerability of Imagify, the NDA submission for Imagify and likelihood of regulatory approval, the commercial opportunity for Imagify, manufacturing qualification, the commercial opportunity for other product candidate and other business development efforts.. 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, future 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 June 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.
Lawrence A. Gyenes, 617-648-8800
Posted: October 2008
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- Acusphere Announces Results of FDA Advisory Committee Meeting - December 11, 2008
- Acusphere, Inc. Announces Posting of Briefing Documents for FDA Cardio Renal Drugs Advisory Committee Meeting on Imagify - December 8, 2008
- Acusphere Announces FDA Acceptance of Imagify NDA for Detection of Coronary Artery Disease - June 30, 2008
- Acusphere Submits New Drug Application for FDA Approval of Imagify - April 29, 2008