Epix Launches Appeal For FDA Approval Of Vasovist
This article was originally published in The Pink Sheet Daily
Executive Summary
Epix is seeking an advisory committee review of its Vasovist imaging agent, which will be marketed by Schering AG if approved.
|
Epix is seeking an advisory committee review of its blood imaging agent Vasovist (gadofosveset) in a formal appeal to the Center for Drug Evaluation & Research's Office of New Drugs. The appeal, submitted June 30, asks that an advisory committee "be utilized as part of the appeal process," the company said. "We are hopeful that we will have the opportunity to present the data from our four completed Phase III trials, as well as other data collected on Vasovist, to an advisory committee as part of the appeal process, and are continuing preparations accordingly," Epix COO Andrew Uprichard said in a statement. The firm is urging approval of the magnetic resonance angiography imaging agent after an arduous path through FDA thus far. The agency has twice issued "approvable" letters seeking additional Vasovist clinical trial data. Epix said in late 2005 that it would conduct a new Phase III trial and a re-read of images from previous Phase III studies after a second "approvable" letter restated FDA's earlier request (1 (Also see "Epix Pegs Vasovist Approval In Second Half 2007 Following Second “Approvable” Letter" - Pink Sheet, 23 Nov, 2005.)). At the time, the firm said it expected approval within 18 to 24 months. Schering AG holds worldwide marketing rights for Vasovist, which was approved in the EU in October for "visualization of abdominal or limb vessels in patients with known or suspected vascular disease such as stenosis and aneurysms" (2 (Also see "Schering AG/Epix Contrast Agent Vasovist Gains EU Approval, Waits For FDA" - Pink Sheet, 5 Oct, 2005.)). In April, Cambridge, Mass.-based Epix announced its acquisition of Predix, a privately held pharmaceutical company based in Lexington, Mass. The transaction was valued at $90 mil. plus up to $35 mil. in milestones, Epix said. The intention of the combined company is to license its later-stage products to larger pharmaceutical companies or biotechs, Epix said. With Predix, Epix acquired PRX-00023, a Phase III treatment for generalized anxiety disorder that has completed enrollment for the first of two planned pivotal trials. Predix said it expects to release preliminary data from the trial by the end of this year. -Shirley Haley |