Acusphere Withdraws its European Marketing Authorization Application for Imagify
LEXINGTON, Mass.--(BUSINESS WIRE)--Acusphere, Inc. (ACUSD.PK) announced today the strategic decision to voluntarily withdraw its Marketing Authorization Application (MAA) submitted to the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for Imagify™ (Perflubutane Polymer Microspheres for Injectable Suspension). The Company intends to continue working with the U.S. Food and Drug Administration (FDA) on the development of Imagify.
“The withdrawal of the MAA in Europe does not affect the status of Imagify’s Special Protocol Assessment with the FDA and we remain committed to completing its clinical development.”
“The withdrawal of the MAA is a difficult but necessary decision at this time. We are choosing to focus our resources on a pivotal trial in the U.S. to strengthen Imagify’s total data package for future partnering discussions and global regulatory submissions,” said Mark Leuchtenberger, President and Chief Executive Officer of Acusphere. “The withdrawal of the MAA in Europe does not affect the status of Imagify’s Special Protocol Assessment with the FDA and we remain committed to completing its clinical development.”
In May 2011, Acusphere reached an agreement with the FDA, under a Special Protocol Assessment (SPA), on the design of a placebo controlled trial to demonstrate that stress ultrasound with Imagify has superior efficacy to stress ultrasound without Imagify.
About Acusphere, Inc.
Acusphere, Inc. (ACUSD.PK) is a specialty pharmaceutical company focused on the development and regulatory approval of our lead product candidate, Imagify™ (Perflubutane Polymer Microspheres for Injectable Suspension). Imagify is a cardiovascular drug for the detection of coronary artery disease, the leading cause of death in the United States and Europe. Imagify was created using proprietary technology that enables Acusphere to control the porosity and size of nanoparticles and microparticles, which were customized to control the delivery of gas needed for ultrasound myocardial perfusion assessment. For more information about Acusphere visit the Company’s website (www.acusphere.com).