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In a release, the company noted that under the amended terms of the License Agreements, it is no longer obligated to make a $15 million milestone payment or any royalty payments upon approval of AI-525 and Cephalon will assume primary responsibility for patent prosecution of licensed technology. As a result of this transaction, Cephalon's Pledge and Security Agreement, and Registration Rights Agreement have also been terminated and Cephalon no longer has a security interest in any of Acusphere's assets. Also as a result of this transaction, Cephalon no longer has any rights related to equity ownership in Acusphere nor any product rights to Imagify (Perflubutane Polymer Microspheres) for Injectable Suspension, Acusphere's lead product candidate.
The company said that Acusphere now has global rights to Imagify, a Perfusion Stress Echo imaging agent for detecting coronary artery disease, the leading cause of death in the U.S. Targeting a $2 billion potential market in the U.S. alone, Imagify is being developed to offer a low cost, radiation free alternative to the 7 million nuclear stress imaging procedures performed each year in the U.S. The Company is currently seeking a partner for the continued development of Imagify. Previously, the Company announced that it received in February 2009 a complete response from the U.S. Food & Drug Administration (FDA) to its New Drug Application (NDA) for Imagify. FDA's response stated that additional clinical work demonstrating Imagify's performance relative to non-contrast ultrasound would be required before approval for marketing in the U.S. The amount of time and funding required to complete the additional clinical work will depend on the design of the clinical program, which will be developed collaboratively with the potential partner and FDA. After the $1 million payment from Cephalon, the Company has approximately $2.8 million in unaudited cash which the Company expects will fund operations to the fourth quarter of 2009 based on the current operating plan.
Acusphere is a specialty pharmaceutical company that develops new drugs and improved formulations of existing drugs using its proprietary microsphere technology.
((Comments on this story may be sent to health@closeupmedia.com))
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