Healthcare Industry News: Alzheimer's disease
News Release - December 14, 2006
EPIX Pharmaceuticals to File Appeal with the Center for Drug Evaluation and Research for Vasovist(TM)LEXINGTON, Mass.--(HSMN NewsFeed)--EPIX Pharmaceuticals, Inc. (NASDAQ: EPIX ) today announced that it will submit a formal appeal to the director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) asking the director to overrule the decision by the Office of New Drugs (OND) denying a previously submitted appeal for its novel blood-pool imaging agent Vasovist(TM) (gadofosveset trisodium injection). The company anticipates submitting the appeal in the first quarter of 2007.
This appeal is in response to OND's denial in August 2006 of EPIX's appeal to OND of two approvable letters. The decision to appeal from OND to the CDER director was made because EPIX vigorously disagrees with CDER's previous determinations that Vasovist has not been shown to be safe and effective for identifying problematic stenosis in the peripheral vasculature. EPIX also plans to reiterate its request for FDA to convene an advisory committee before deciding on this new appeal. The company believes that where, as here, there is clear-cut scientific disagreement FDA should not refuse a request to allow external experts to provide their independent viewpoints. The time needed for the CDER director to hear the appeal will depend on whether FDA agrees to convene an advisory committee and, if so, how long that process takes.
Andrew Uprichard, M.D., president of EPIX Pharmaceuticals, said, "We are very pleased that regulatory authorities for the European Community, Switzerland, Canada, and Australia have already approved Vasovist for the visualization of peripheral vascular disease. We look forward to approval in the U.S."
Vasovist is an injectable intravascular contrast agent designed to provide visual imaging of the vascular system through magnetic resonance angiography. 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, where it is marketed by Schering 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 a blood-pool imaging agent approved and marketed in Europe (Vasovist(TM)), and 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 EP-2104R, a novel thrombus imaging agent which has completed a Phase 2a trial, 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, and PRX-07034, which is in Phase 1 clinical development for the treatment of obesity and cognitive impairment. EPIX also has collaborations with leading organizations, including GlaxoSmithKline, Amgen, Cystic Fibrosis Foundation Therapeutics, and Schering 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.
Source: EPIX Pharmaceuticals
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