Acusphere Changes FDA Approval Strategy for its Imagify Echo Contrast Agent

 

February 19, 2009

February 19, 2009 - Acusphere Inc. today submitted an amendment to its new drug application (NDA) for its ultrasound contrast agent Imagify (perflubutane polymer microspheres for injectable suspension), which is designed for the detection of coronary artery disease.

The NDA was submitted to the 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 cardiac stress imaging procedures are done each year in the U.S., of which 6.5 million are conducted with exercise stress and 3.5 million are conducted with pharmacologic stress. If FDA accepts the submitted amendment, the Imagify indication will be limited to subsets of patients undergoing pharmacologic stress techniques.

The amended indication is focused on patients where the risk-to-benefit ratio of Imagify is more compelling than the broader indication that was originally filed. Since this is a significant amendment to the NDA for Imagify, the company said it is likely the FDA will push back the Prescription Drug User Fee Act (PDUFA) target date for their complete response letter from Feb. 28, 2009 to May 31, 2009.

The company has engaged in discussions to reduce, defer or eliminate costs to ensure that it can fund its operations beyond the anticipated PDUFA date of May 31, 2009. The company also announced today that it had completed the renegotiation of payment terms under certain intellectual property agreements. Payments totaling about $6.7 million due in 2009 will be reduced to $350,000 immediately, with another $350,000 payable upon a financing of the company, and the remainder due in 2013. In addition, the company announced last week that the Board of Directors elected not to declare a quarterly cash dividend to holders of it 6.5 percent convertible exchangeable preferred stock that was otherwise payable on March 1, 2009, saving an additional $195,000.

“These actions will carry us into June 2009 at our current burn rate and, together with discussions already in progress and other cost reduction initiatives, could allow us to explore strategic partnerships and financing alternatives following the receipt of the FDA response to our proposed amendment,” said Lawrence A. Gyenes, Acusphere’s CFO.

Acusphere is a specialty pharmaceutical company that develops new drugs and improved formulations of existing drugs using its proprietary microsphere technology. The company’s lead product candidate is Imagify. The company’s proprietary technology enables control of the porosity and size of nanoparticles and microspheres in a manner that allows them to be customized to address the delivery needs of a variety of drugs.

For more information: www.acusphere.com