PIX Pharmaceuticals announced that it has reached agreement with the US FDA on its proposal for the re-read of images of its novel blood pool magnetic resonance angiographic agent, Vasovist (gadofosveset trisodium).

EPIX has received an Action Letter from the FDA confirming that the jointly agreed-upon protocol design and statistical analysis plan adequately address the objectives necessary to support the resubmission of the New Drug Application (NDA) for Vasovist. EPIX has initiated the re-read of images obtained in prior Phase 3 studies. Vasovist has been approved for marketing in 33 countries outside of the US.

"We are extremely pleased with the progress we have made with the FDA," said Andrew Uprichard, M.D., Ph.D., president and head of research and development at EPIX. "We have designed a protocol with input from the FDA that outlines the methodology of conducting the re-read of images and the statistical analysis of the data. As we announced in June 2007, the FDA has indicated that a blinded re-read of the images obtained from the previously completed Phase 3 clinical trials of Vasovist could support approval if the results meet the pre-specified endpoints agreed with the Agency. We expect to submit these results in mid 2008.