Edge Therapeutics Announces Commercial Supply Agreement With Oakwood Laboratories
Edge Therapeutics, Inc. recently announced it has entered into a supply agreement and an amended and restated development agreement with Oakwood Laboratories for the commercial manufacturing of EG-1962 for initial product launch and thereafter. EG-1962, an orphan drug and Fast Track product designated by the US FDA, is currently in Phase 3 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 3 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 proprietary PrecisaTM development platform and is designed to improve patient outcomes following aSAH. EG-1962, administered through an EVD, is currently being studied in the pivotal Phase 3 NEWTON 2 study. EG-1962 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA), and orphan drug designation by the FDA and the European Commission.
Edge Therapeutics, Inc. is a clinical-stage biotechnology company that discovers, develops and seeks to commercialize novel, hospital-based therapies capable of transforming treatment paradigms for the management of acute, life-threatening neurological and other conditions. EG-1962, Edge’s lead product candidate, has the potential to fundamentally improve patient outcomes and transform the management of aneurysmal subarachnoid hemorrhage, which is bleeding around the brain due to a ruptured brain aneurysm. Edge is evaluating EG-1962 in two clinical studies: a pivotal Phase 3 NEWTON 2 study of EG-1962 delivered via external ventricular drain, and a study of direct intracisternal administration of EG-1962. For more information, visit www.edgetherapeutics.com.
Total Page Views: 1219
