LEXINGTON, Mass.–(BUSINESS WIRE)–July 1, 2008–EPIX Pharmaceuticals, Inc. (NASDAQ:EPIX), a biopharmaceutical company focused on discovering and developing novel therapeutics through the use of its proprietary and highly efficient in silico drug discovery platform, announced today that the New Drug Application (NDA) for its novel blood pool magnetic resonance angiography (MRA) agent, Vasovist (gadofosveset trisodium) was resubmitted to the U.S. Food and Drug Administration (FDA) on June 30, 2008.
If approved, Vasovist will be the first contrast agent approved for marketing in the United States for use with MRA, a non-invasive modality for imaging blood vessels. In 2007, there were approximately 1.3 million MRA procedures performed in the United States using contrast agents.
We look forward to continuing to work with the FDA to bring Vasovist to market in the United States, said Michael G. Kauffman, M.D., Ph.D., chief executive officer of EPIX. Throughout the appeal process for Vasovist, we worked closely with the FDA and the resubmission is a culmination of the work done by our team at EPIX. We remain hopeful that we will achieve approval for Vasovist by the end of 2008 and are focused on executing our strategy to monetize our interest in this valuable asset.
Vasovist is an injectable intravascular contrast agent designed to provide improved imaging of the vascular system through magnetic resonance angiography imaging (MRA). Vasovist has been approved for marketing in 33 countries, including all 27 member states of the European Union, Switzerland, Turkey, Australia and Canada. The marketing rights to Vasovist are held by Bayer Schering Pharma in Europe and by Bayer HealthCare Pharmaceuticals in the United States and Canada. Both companies are part of Bayer AG. Vasovist is currently marketed in Canada and 18 European countries, including Germany, the Netherlands, Italy, all Nordic countries, the United Kingdom and Switzerland.