Edge Therapeutics, Inc. has entered into a supply agreement and an amended development agreement with Oakwood Laboratories for the commercial manufacture of EG-1962 for initial product launch and commercialization. EG-1962, an orphan drug with Fast Track product designation by the FDA, is currently in Phase III development for the treatment of aneurysmal subarachnoid hemorrhage (aSAH).

“These new agreements are an important step in establishing the supply of EG-1962 for potential commercialization, and we look forward to expanding our relationship with Oakwood Laboratories,” said Brian A. Leuthner, Edge’s president and chief executive officer. “We have been working with Oakwood for a period of time from process development through the manufacturing of the EG-1962 clinical supply used in our ongoing NEWTON 2 Phase III clinical study, and we were impressed by their capabilities in polymer-based microparticles and their ability to meet our timelines.”

EG-1962 is a novel polymeric microparticle containing nimodipine suspended in a diluent of sodium hyaluronate. EG-1962 utilizes Edge’s Precisa development platform and is designed to improve patient outcomes following aSAH.