EPIX RECEIVES FDA RESPONSE TO APPEAL OF APPROVABLE LETTERS

Epix Pharmaceuticals has received a letter from the FDA denying the company's formal appeal to approve its blood-pool imaging agent Vasovist (gadofosveset trisodium) and turning down its request for an advisory committee review of Vasovist.

In its response letter, the Office of New Drugs (OND) of the FDA also suggested that, if Epix decides to conduct additional clinical research, a safer course of action would be to conduct two new clinical trials to support the application for approval, rather than relying on a blinded re-read of previously submitted data and data from a new clinical trial. Epix submitted the appeal to the OND on June 30 in response to two prior approvable letters for Vasovist.

"We are evaluating several options available to us as next steps with Vasovist in the United States, including the option to appeal this decision to the next level at the FDA," Andrew Uprichard, president of Epix, said.

Vasovist is an injectable intravascular contrast agent designed to provide visual imaging of the vascular system through magnetic resonance angiography. In October 2005, the European Medicines Agency granted marketing approval for Vasovist in all 25 members of the European Union. It has also been approved in Switzerland and recommended for approval in Australia.