Epix Medical MS-325 Imaging Agent NDA Filing Targeted For Early 2003
This article was originally published in The Gray Sheet
Executive Summary
Initial results from one of Epix Medical's four Phase III trials of the magnetic resonance imaging intravascular contrast agent MS-325 will be released at the upcoming American College of Cardiology annual meeting, March 17-20 in Atlanta
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Epix/Schering Vascular Imaging Agent Approval Delayed, Needs New Trial
Epix' MS-325 magnetic resonance angiography vascular imaging agent will need additional studies prior to approval due to a lack of standardization in non-contrast comparator scans
Epix/Schering Vascular Imaging Agent Approval Delayed, Needs New Trial
Epix' MS-325 magnetic resonance angiography vascular imaging agent will need additional studies prior to approval due to a lack of standardization in non-contrast comparator scans
Epix Medical
Cardiovascular magnetic resonance imaging agent pact will result in a $10 mil. up-front fee and $20 mil. in milestone payments from Schering AG. MS-325, formerly known as AngioMark and designed to detect blockages in the cardiovascular system, will be co-developed and sold worldwide by Schering (excluding Japan). Epix will complete Phase III trials currently underway and file for FDA approval. Mallinckrodt will manufacture the product under a long-term supply contract. Epix and Schering will split U.S. profits and Schering will pay royalties for other markets. Under a separate strategic partnership agreement for development of additional cardiovascular MRI agents, Schering will make a $20 mil. equity investment in Epix