November 11, 2008
Acusphere Announces Data Demonstrating Imagify(TM) Perfusion Stress Echo Predicts Presence of Coronary Artery Disease
Acusphere, Inc. (NASDAQ: ACUS) announced that additional analyses from its Phase 3 clinical trials of Imagify(TM) (Perflubutane Polymer Microspheres) for Injectable Suspension were presented today at the annual American Heart Association Scientific Sessions in New Orleans, Louisiana. These results build upon the thesis presented at AHA last year that Imagify Perfusion Stress Echo is an effective and well-tolerated, minimally invasive approach to evaluating chest pain patients at risk for heart attack. The new analysis ascribes incremental predictive value to the use of Imagify for detecting coronary artery disease over other current clinical risk factors.
Imagify is the first echocardiography imaging agent designed and shown in clinical trials to assess myocardial perfusion (blood flow in the heart) accurately. Myocardial perfusion is a sensitive marker of coronary artery disease (CAD). Currently, perfusion information is not available using stress echocardiography (cardiac ultrasound), but must be obtained using a nuclear stress test. Imagify Perfusion Stress Echo would have many potential benefits over nuclear stress testing including quicker results, lower cost and no exposure to radioactivity. More than 10 million stress imaging procedures are done each year in the U.S. to detect CAD, the leading cause of death in the United States.
"We are pleased that the American Heart Association has once again selected additional analyses of Acusphere's clinical trials on Imagify for oral presentation to the physician community here at the Scientific Sessions. We are confident that the continuing interest from clinicians for a valuable non-invasive predictive tool that helps detect coronary artery disease early on will assist us as we await approval from the U.S. Food & Drug Administration for Imagify," said Sherri C. Oberg, President and CEO of Acusphere. "Imagify is a novel cardiac perfusion imaging agent, which for the first time will enable myocardial blood flow assessment in stress echo procedures, addressing a significant medical need."
Michael Picard, M.D., Director, Clinical Echocardiography at Massachusetts General Hospital Heart Center gave the presentation and stated, "As described in the presentation, we continue to see that Perflubutane Polymer Microspheres for Injectable Suspension represent a technique that can easily be integrated into the current application of echocardiography. While we currently detect wall motion abnormalities with cardiac ultrasound the simultaneous addition of myocardial blood flow information that this technique makes possible should provide strong benefits in helping us better evaluate patients at risk for heart disease. The results presented today suggest that the power to enable assessment of both wall motion and blood flow is a stronger predictor of coronary artery disease, and indeed stronger than the other clinical risk factors that most clinicians currently use."
The abstract presented by Dr. Picard at today's session is published in the current Supplement to Circulation: Journal of the American Heart Association.
The expected FDA target action date for Imagify under the Prescription Drug User Fee Act (PDUFA) is February 28, 2009.
Imagify(TM), (Perflubutane Polymer Microspheres) for Injectable Suspension, is an investigational new drug developed to assess perfusion using ultrasound (or echocardiography) for the detection of coronary artery disease. Myocardial perfusion is blood flow in the heart muscle and is a sensitive marker of coronary artery disease. Currently, perfusion information is not available using cardiac ultrasound but must be obtained using a nuclear stress test, which is the most frequently used imaging procedure for detecting coronary artery disease. Imagify is designed to provide real-time perfusion information with quicker results, lower cost, broader access and no exposure to radiation compared with nuclear stress tests. Imagify was designed to be used with commercially available ultrasound equipment and established imaging techniques.
According to the American Heart Association, approximately 16 million people in the United States suffer from coronary artery disease, the single leading cause of death in the United States. CAD is characterized by the accumulation of plaque, which narrows coronary arteries and reduces blood flow in the heart muscle. The reduced blood flow can cause chest pain, and if the plaque ruptures, it may cause a heart attack. The American Heart Association estimates that the direct and indirect cost of CAD in the United States for 2007 is more than $150 billion.
Early detection of CAD can save lives, reduce treatment costs and improve patients' quality of life. Two of the most common methods of CAD screening are nuclear stress imaging and stress echocardiography, or "stress echo"-- ultrasound of the heart. In 2006, more than 10 million of these screening procedures were performed in the United States, including more than seven million nuclear stress tests and nearly three million stress echo procedures.
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(TM) (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 over 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. 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 development and commercial opportunity for Imagify. 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 the Company's Quarterly Report on Form 10-Q for the quarter ended September 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.