EPIX Pharmaceuticals Files Formal Appeal for Vasovist(TM) with the Center for Drug Evaluation and Research
- Category: Small Molecules
- Published on Thursday, 01 March 2007 02:00
- Hits: 2297
LEXINGTON, MA, USA | Feb 28, 2007 | EPIX Pharmaceuticals, Inc. (NASDAQ: EPIX) today announced that it has submitted a formal appeal to Steven Galson, M.D., director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) asking the CDER director to approve the company's novel blood-pool imaging agent Vasovist(TM) (gadofosveset trisodium injection). In the filing, EPIX has asked that an Advisory Committee be considered as part of the appeal process. The company expects that the CDER director will respond to its submission within approximately 30 days, although any decision could be postponed until an Advisory Committee meeting if CDER grants the company's request for one.
"As we said at the end of last year, we had planned to file a formal appeal to the Center for Drug Evaluation and Research in the first quarter of 2007," said Andrew Uprichard, M.D., president of EPIX Pharmaceuticals. "Vasovist has been approved for clinical use in the European Community, Canada, Norway, Iceland, and Australia for the visualization of abdominal and peripheral vascular disease and in Switzerland for magnetic resonance angiography (MRA) of the whole body. We are hopeful that we will have the opportunity to present data from our four Phase 3 trials along with other data collected on Vasovist to an Advisory Committee as part of the appeal process."
Vasovist is an injectable intravascular contrast agent designed to provide visual imaging of the vascular system through MRA. The initial target indication for Vasovist is for use in magnetic resonance angiography imaging of non-coronary vascular disease. Vasovist has been approved for marketing in 30 countries including all 25 member states of the European Union, Norway, Iceland, Switzerland, Australia and Canada. Vasovist is marketed by Bayer Schering Pharma AG, Germany.
About EPIX Pharmaceuticals
EPIX Pharmaceuticals is a biopharmaceutical company focused on discovering, developing and commercializing novel pharmaceutical products through the use of proprietary technology to better diagnose, treat and manage patients. The company has five internally-discovered therapeutic and imaging drug candidates currently in clinical trials targeting conditions such as depression, Alzheimer's disease, cardiovascular disease and obesity. These drug candidates include PRX-08066 in Phase 2 clinical development for pulmonary hypertension associated with chronic obstructive pulmonary disease, PRX-03140 which is in a Phase 2a clinical trial in Alzheimer's disease, PRX-00023 which is being developed to treat major depression, and PRX-07034, which is in Phase 1 clinical development for the treatment of obesity and cognitive impairment. The company also has a blood-pool imaging agent (Vasovist(TM)) approved in 30 countries and marketed in Europe. EPIX also has collaborations with leading organizations, including GlaxoSmithKline, Amgen, Cystic Fibrosis Foundation Therapeutics, and Bayer Schering Pharma AG, Germany. For more information about EPIX, 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 our regulatory strategies for Vasovist. 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: our failure to comply with regulations relating to our products and product candidates, including FDA requirements; failure to obtain the financial resources to complete development of product candidates; the risk that the FDA may interpret the results of our studies differently than we have; the risk that clinical trials may not result in marketable products; the risk that we may be unable to successfully secure regulatory approval of and market our drug candidates; 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 Quarterly Report on Form 10-Q.
Kim C. Drapkin, 781-761-7602
Chief Financial Officer
Sheryl Seapy, 949-608-0841
SOURCE: EPIX Pharmaceuticals, Inc.