Healthcare Industry News: gadofosveset
News Release - November 6, 2006
EPIX Announces Canadian Approval of Vasovist(TM); Marks 30th Country in Which Vasovist is Approved for MarketingLEXINGTON, Mass.--(HSMN NewsFeed)--EPIX Pharmaceuticals, Inc. (NASDAQ:EPIX ) today announced that Health Canada's Health Products and Food Branch (HPFB) has approved its novel blood pool imaging agent Vasovist for marketing in Canada. Vasovist (gadofosveset trisodium injection) is indicated for contrast-enhanced magnetic resonance angiography (MRA) for visualization of abdominal or limb vessels in patients with suspected or known vascular disease.
"We are delighted with this approval of Vasovist in Canada, which represents the 30th country in which Vasovist is approved for marketing," stated Andrew Uprichard, MD, president of EPIX Pharmaceuticals. "We remain in dialogue with the U.S. Food and Drug Administration regarding the path to approval for Vasovist in the U.S."
Dr. Uprichard added, "In addition to this milestone for Vasovist, data from our Phase 2a clinical trial of EP-2104R, our novel thrombus imaging agent, will be the subject of an oral presentation at the Radiological Society of North America (RSNA) later this month. These achievements further demonstrate the significant progress we have made in the clinical development of our robust pipeline of novel imaging and therapeutic product candidates."
Vasovist is an injectable intravascular contrast agent designed to provide visual imaging of the vascular system through magnetic resonance angiography which has been developed in collaboration with and will be marketed by Schering AG, Germany. The initial target indication for Vasovist is for use in magnetic resonance angiography imaging of non-coronary vascular disease. In October 2005, the European Medicines Agency granted marketing approval of Vasovist to Schering for all 25 member states of the European Union. Vasovist has also been approved in Norway, Iceland, Switzerland, Australia and Canada.
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 MR imaging agent (Vasovist) approved and marketed in Europe by Schering AG, 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, and PRX-03140, which has completed a Phase 1b clinical trial in Alzheimer's patients. EPIX also has collaborations with leading organizations, including 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 and business strategies,,including the initiation of clinical trials,the timing of clinical trial results, product performance and growth opportunities 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: risks that product candidates may fail in the clinic or may not be successfully marketed or manufactured; any 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 FDA may interpret the results of our studies differently than we have; competing products may be more successful; our inability to interest potential partners in our technologies and products; our inability to achieve commercial success for our products and technologies; the possibility of delays in the research and development necessary to select drug development candidates and delays in clinical trials; 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.
Source: EPIX Pharmaceuticals
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