Epix Pharmaceuticals, Inc, 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 that the US Food and Drug Administration (FDA) has approved for marketing its novel blood pool magnetic resonance angiography (MRA) agent, Vasovist (gadofosveset trisodium), to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease. AIOD occurs when iliac 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 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 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 United States based on data from four multi-center, Phase 3 clinical trials that showed that Vasovist's overall accuracy was similar to that of catheter-based x-ray angiography, as determined by blinded readings.

"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," said Elkan Gamzu, interim chief executive officer of EPIX. "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. In addition, the albumin-binding properties of Vasovist make it ideal for vascular imaging as opposed to other gadolinium agents that are rapidly cleared from the blood stream and have a narrow imaging window. There are no other imaging agents approved for MRA in the United States and we believe Vasovist will be well-received by the physician community as a valuable, safe tool for MRA. Our strategy remains to monetize this asset and we believe these characteristics and market dynamics make Vasovist an appealing opportunity for a company interested in building or augmenting its competitive position in the imaging market."

The approval was based on the positive results from a blinded, independent re-read of images of Vasovist from previous Phase 3 studies. The re-read, which was conducted earlier this year, met all pre-specified endpoints prospectively agreed to with the FDA.

Vasovist is an injectable intravascular contrast agent designed to provide improved imaging of the vascular system through magnetic resonance angiography imaging (MRA).