Healthcare Industry News: Bayer HealthCare
News Release - July 1, 2008
EPIX Pharmaceuticals Announces Resubmission of New Drug Application for Vasovist(R)LEXINGTON, Mass.--(HSMN NewsFeed)--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.
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 and assumptions concerning regulatory approval of Vasovist and the expected timing thereof, the company’s ability to monetize its interest in Vasovist and management's plans, objectives and strategies. 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 Vasovist may not be successfully marketed or manufactured; 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; 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; the risk that we may be unable to successfully secure regulatory approval of and market Vasovist; 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.
Source: EPIX Pharmaceuticals
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