EPIX TO APPEAL VASOVIST DECISION

Epix Pharmaceuticals has announced it will submit a formal appeal to the director of the FDA's Center for Drug Evaluation and Research (CDER) asking the director to overrule the decision by the Office of New Drugs (OND) denying a previously submitted appeal for its blood-pool imaging agent Vasovist (gadofosveset trisodium injection). The company anticipates submitting the appeal in the first quarter of 2007.

Epix received a response from the OND in August denying the company's formal appeal of two approvable letters and turning down its request for an advisory committee review of Vasovist. The company appealed the letters because vigorously disagrees with CDER's determination that Vasovist has not been shown to be safe and effective for identifying problematic stenosis in the peripheral vasculature.

The company plans to reiterate its request for the FDA to convene an advisory committee before deciding on this new appeal. The company believes that where there is clear-cut scientific disagreement, the FDA should not refuse a request to allow external experts to provide their independent viewpoints.

The European Medicines Agency granted marketing approval for Vasovist in 2005. It has also been approved in Switzerland, Canada and Australia.