EPIX Pharmaceuticals Inc. (Nasdaq:EPIX) share has more than quadrupled over the past few days following receipt of US Food and Drug Administration (FDA) approval for marketing its novel blood pool magnetic resonance angiography (MRA) agent, Vasovist.
Israeli company EPIX, which discovers and develops novel therapeutics, had been waiting three years for the approval.
On Monday, EPIX's share price quadrupled, and a further 38% rise yesterday saw the value reach $1.66 per share giving a market cap of $69.19 million.
Vasovist evaluates aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease. AIOD occurs when arteries become narrowed or blocked and may prevent the sufficient transport of oxygen and/or blood throughout the body.
Vasovist is the first contrast agent approved for marketing in the US for use with MRA, a non-invasive method of imaging blood vessels. In 2007, there were approximately 1.3 million MRA procedures performed in the United States using contrast agents not specifically approved for this procedure. MRA is a less invasive procedure than x-ray angiography, allowing for reduced patient discomfort and recuperation time and unlike x-ray angiography, MRA does not expose patients to ionizing radiation.
Vasovist had previously been approved for marketing in 34 countries outside the US based on data from four multi-center, Phase III clinical trials that showed that Vasovist’s overall accuracy was similar to that of catheter-based x-ray angiography, as determined by blinded readings.
EPIX interim CEO Elkan Gamzu said, “Vasovist is a first-in-class contrast agent with several unique characteristics that we believe will allow it to become a market leader in the United States. It offers good resolution angiography, a high signal per dose, a long imaging window timeframe and single-dose imaging of multiple vessel beds. We believe the resulting high-quality image will allow physicians to fully utilize MRA as a meaningful diagnostic and therapeutic tool."
Published by Globes [online], Israel business news - www.globes-online.com - on December 24, 2008
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