Acusphere Announces that Imagify Safety and ECHO Reader Training Data Will Be Presented at EuroEcho 2007
Dr. Richard Walovitch, Acusphere's Senior Vice President of Clinical Research, said, "We are very pleased to have the opportunity to present this important safety data from our Phase 3 clinical trials for Imagify at one of the leading events for echocardiologists throughout the world. We are very excited with the positive outcome that this peer-reviewed analysis presents."
In addition, one of the ECHO blinded readers in Acusphere's Phase 3 clinical trials, Dr. Harald Becher, Director, Cardiac Ultra-sound Unit, John Radcliffe Hospital in Oxford, England, will present at EuroECHO 2007 on the same day and time another poster on Imagify entitled "Impact of Focused Training on Increased Sensitivity and Consistency of Perfusion Stress Contrast."
Added Dr. Walovitch, "Dr. Becher's presentation provides insight into how to teach cardiologists strategies to optimize Imagify image interpretation. We are confident that these findings will be quite useful as we move forward with our commercialization plans for Imagify."
EuroEcho is the major annual educational and research meeting in cardiovascular ultrasound in Europe, showcasing some of the most important scientific data on echocardiography and attracting participants from around the world.
In the RAMP-1 and -2 trials, Imagify was well-tolerated with the majority of adverse events (AEs) reported being mild in intensity, transient, and resolved without residual effects. The most common AEs reported were headache, chest pain or discomfort, nausea and flushing and occurred following dipyridamole dosing (an alternative to exercise stress).
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. In May 2007 we announced the results of our Phase 3 pivotal trials for Imagify. We are currently working towards submitting an NDA (New Drug Application) for Imagify. 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 commercial opportunity for Imagify and statements regarding the timing and likelihood of regulatory approval, and the commercial prospects for, Imagify. There can be no assurance that the FDA will accept the Company's NDA for Imagify or 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 with respect to Imagify and uncertainties regarding the potential affects 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2007. 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.
For Acusphere, Inc.
Mary T. Conway, 617-244-9682
Posted: December 2007