EPIX Pharmaceuticals Reaches Agreement with FDA on Protocol, Initiates Re-Read of Vasovist(TM) Phase 3 Images

EPIX Pharmaceuticals, Inc. (NASDAQ: EPIX) today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on its proposal for the re-read of images of its novel blood pool magnetic resonance angiographic (MRA) agent, Vasovist™ (gadofosveset trisodium). EPIX has received an Action Letter from the FDA confirming that the jointly agreed-upon protocol design and statistical analysis plan adequately address the objectives necessary to support the resubmission of the New Drug Application (NDA) for Vasovist. EPIX has initiated the re-read of images obtained in prior Phase 3 studies. Vasovist has been approved for marketing in 33 countries outside of the U.S. "We are extremely pleased with the progress we have made with the FDA,” said Andrew Uprichard, M.D., Ph.D., president and head of research and development at EPIX. "We have designed a protocol with input from the FDA that outlines the methodology of conducting the re-read of images and the statistical analysis of the data. As we announced in June 2007, the FDA has indicated that a blinded re-read of the images obtained from the previously completed Phase 3 clinical trials of Vasovist could support approval if the results meet the pre-specified endpoints agreed with the Agency. We expect to submit these results in mid 2008.” About Vasovist™ Vasovist is an injectable intravascular contrast agent designed to provide visual imaging of the vascular system through magnetic resonance angiography imaging (MRA). The initial target indication for Vasovist is for use in MRA imaging of the non-coronary vascular system. Vasovist has been approved for marketing in 33 countries, including among others 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 among others Germany, the Netherlands, Italy, all Nordic countries, United Kingdom, and Switzerland. About EPIX EPIX Pharmaceuticals is a biopharmaceutical company focused on discovering and developing novel therapeutics through the use of its proprietary and highly efficient in silico drug discovery platform. The company has a pipeline of internally-discovered drug candidates currently in clinical development to treat diseases of the central nervous system and lung conditions. EPIX also has collaborations with leading organizations, including GlaxoSmithKline, Amgen, Cystic Fibrosis Foundation Therapeutics and Bayer Schering Pharma. For more information, please visit the company’s website at www.epixpharma.com. This news release contains express or implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are based on current expectations of management. These statements relate to, among other things, our expectations regarding the clinical development of Vasovist and timing of the results of any re-read of images obtained in the previously completed clinical trials. These statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. In particular, the risks and uncertainties include, among other things: risks that product candidates may fail in the clinic or may not be successfully marketed or manufactured; risks relating to our ability to advance the development of product candidates currently in the pipeline or in clinical trials; failure to obtain the financial resources to complete development of product candidates; our inability to further identify, develop and achieve commercial success for new products and technologies; our inability to achieve commercial success for our products and technologies; our failure to comply with regulations relating to our products and product candidates, including FDA requirements; the risk that the FDA may interpret the results of our studies differently than we have; and risks of new, changing and competitive technologies and regulations in the U.S. and internationally. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. We undertake no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. For additional information regarding these and other risks that we face, see the disclosure contained in our filings with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q.