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European approval for Epix’s vascular visualization drug

Epix Pharmaceuticals' lead product, Vasovist, has been given European regulatory approval for visualization of abdominal or limb vessels in patients with known or suspected vascular disease using magnetic resonance angiography.

Schering AG will market the product in Europe, and in other countries where Vasovist may receive approval.

Millions of people worldwide suffer from various forms of vascular disease. In the EU alone more than two million people are hospitalized and an estimated four million patients per year undergo invasive, catheter-based X-ray angiography (XRA). Magnetic resonance angiography (MRA) with Vasovist may represent an alternative to XRA as a minimally invasive method.

The product uniquely demonstrates prolonged blood residence time which may allow radiologists to visualize the vasculature by MRA with a single Vasovist injection. Vasovist enhanced MRA, therefore, may provide the clinician with a robust and flexible tool to perform a comprehensive diagnostic work-up as compared to currently available angiographic techniques.

“With this approval, Epix joins the ranks of commercial biopharmaceutical companies,” said Michael Astrue, Interim CEO of Epix. “This accomplishment is an important milestone not only for our company, but more importantly for the patients and physicians in Europe who will benefit from this safe and effective way to obtain high quality images of diseased blood vessels. We continue to work with the FDA toward the goal of allowing patients in the US to have the same opportunity.”