Acusphere submits new Imagify indication to FDA, renegotiates payments

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On the heels of a Nasdaq delisting and the resignation of its trial overseer, Acusphere has submitted an amendment to its new drug application (NDA) with the FDA for Imagify for injectable suspension, suggesting usage in subsets of patients undergoing pharmacologic stress techniques.

Imagify (Perflubutane Polymer Microspheres) was designed for the detection of coronary artery disease. The NDA was submitted to the FDA in April 2008 and filed in June 2008. In December of the same year, an FDA panel rejected the company's regulatory application due to inconsistent data proving its benefits.

"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, it is likely that the FDA will push back the Prescription Drug User Fee Act (PDUFA) target date for their complete response letter from February 28, 2009 to May 31, 2009," the Watertown, Mass.-based company said.

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.

Additionally, Acusphere said it has renegotiated payment terms under certain intellectual property agreements. Payments totaling approximately $6.7 million due in 2009 will be reduced to $350,000 immediately, with another $350,000 payable upon a financing, and the remainder due in 2013.

Last week, 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, saving an additional $195,000, the company said.

"We are very pleased to reach these agreements. 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, chief financial officer of Acusphere.