EPIX WINS CANADIAN APPROVAL FOR VASOVIST

Epix Pharmaceuticals announced that Health Canada has approved its novel blood pool imaging agent Vasovist for marketing in Canada. Vasovist (gadofosveset trisodium injection) is indicated for contrast-enhanced magnetic resonance angiography for visualization of abdominal or limb vessels in patients with suspected or known vascular disease.

"We are delighted with this approval of Vasovist in Canada, which represents the 30th country in which Vasovist is approved for marketing," Andrew Uprichard, president of Epix, said. "We remain in dialogue with the U.S. Food and Drug Administration regarding the path to approval for Vasovist in the U.S."

Epix received a letter from the FDA in August denying the company's formal appeal to approve Vasovist and turning down its request for an advisory committee review of the agent. The company had submitted the appeal in June in response to two approvable letters for Vasovist.

The European Medicines Agency in 2005 granted marketing approval for Vasovist in all 25 members of the European Union. The agent has also been approved in Norway, Iceland, Switzerland, Australia and Canada.