FDA Closer to Approval of EPIX's Vasovist

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Includes: AMGN, BYERF, EPIX, GSK
by: 48020465

In October 2005, the European Medicines Agency granted EPIX Pharmaceuticals marketing approval of Vasovist to the 25 member states of the European Union. With this approval, Bayer Schering Pharma AG Germany (OTC:BYERF), EPIX’s partner for Vasovist, began marketing Vasovist throughout Europe in the second quarter of 2006. With the addition of Bulgaria, and Romania to the E.U. in 2007, Vasovist is now approved in all 27 member states. Vasovist is an injectable intravascular contrast agent designed to provide visual imaging of the vascular system through magnetic resonance angiography.

The FDA, which is known to be slower at approving new drugs than its foreign counterparts, still has not given its approval for the drug to be marketed in the United States. Last week, on the U.S. side, the company heard positive news from the Food and Drug Administration that said they might waive the requirement for the completion of one or two more clinical trials which they had previously required. This is beginning to lead to the company getting more analyst attention, as Maxim Group just initiated coverage with a target price of $10.

EPIX has developed some close ties with some of the powerhouse pharmaceutical giants including GlaxoSmithKline (NYSE:GSK) Amgen (NASDAQ:AMGN), and Bayer Schering Pharma AG , Germany, the world’s market-leading MRI pharmaceutical company. Even though the FDA approval could take six months or longer, these critical alliances should help to insure quick access to the market for Vasovist, when and if it gets the government’s approval for distribution.

EPIX 1-yr chart:
EPIX 1-yr chart

Disclosure: The author’s fund is does not own any of the companies mentioned herein as of July 1, 2007.

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