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Monday, December 29, 2008

Epix gets FDA OK for imaging agent Vasovist


Epix Pharmaceuticals Inc. has won approval from the U.S. Food and Drug Administration for its lead product Vasovist Injection (gadofosveset trisodium).

According to the FDA, this is the first contrast imaging agent approved to be used on patients undergoing MRA (magnetic resonance angiography), according to the. An MRA is a minimally invasive scan for examining blood vessels and uses MRI technology. Vasovist is designed to help doctors see possible blood vessel problems on the scan.

Lexington-based Epix (Nasdaq: EPIX) said there were 1.3 million MRA procedures performed in the United States using contrast agents not specifically approved for this purpose.

Vasovist is now approved for marketing in 35 different countries. Global marketing rights for Vasovist are held by Bayer Schering Pharma until March 1, 2009, when marketing rights revert to Epix.

In October, Epix announced a plan to cut about 23 percent of its workforce and tighten its research and development in an effort to save money. The layoffs would save the company about $3 million in salary and benefits and would cost about $300,000 in termination fees, Epix officials reported.

Epix, founded in 1988 as Metacorp Inc., is a biopharmaceutical company focused on therapeutics through the use of an in silico drug discovery platform. The company reported a net loss of $62.8 million on revenue of $14.96 million in 2007.

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