In Brief: Nycomed/Centeon
This article was originally published in The Gray Sheet
Executive Summary
Nycomed/Centeon: Announce letter of intent under which Centeon will gain the exclusive rights to market Nycomed's TachoComb fibrin adhesive product to all countries outside of Europe, excluding Japan and certain other countries. Under terms of the deal, Centeon will make a down payment to Nycomed and contribute to TachoComb's worldwide development. Centeon also will fund and perform clinical development for the product in the U.S. and counties outside of Europe. TachoComb, a collagen fleece coated with a fibrin sealant, complements Centeon's fibrin sealant BeriPlast, both of which are used in tissue sealing and the control of bleeding. FDA currently is reviewing data from overseas trials of BeriPlast to determine whether the information is sufficient to support a premarket approval application or whether additional U.S. trials will be needed, Centeon says...