Edge Therapeutics, Inc., a specialty pharmaceutical company focused on improving the delivery of life-saving medicines to the brain announced that it has entered into a feasibility agreement with SurModics, Inc., a leading provider of drug delivery and surface modification technologies to the healthcare industry. According to the agreement, SurModics will develop a novel biodegradable, site-specific, sustained-release formulation (NimoGel, EG-1961) for treatment of delayed complications of ruptured brain aneurysms or traumatic brain injury (TBI). NimoGel, Edge’s lead drug, is a combination of the FDA-approved drug nimodipine, a calcium channel blocker, and a proprietary biodegradable delivery system designed to be injected delivered directly into the subarachnoid space around the brain.
“The need for effective ways to improve treatment of cerebrovascular bleeding events has never been greater than it is today,” said J. Paul Muizelaar, MD, PhD, Professor and Chair of the Department of Neurosurgery at the University of California at Davis and a member of Edge Therapeutics’ Scientific Advisory Board. “There is a strong rationale for delivering nimodipine once locally to the site of the bleed and sustain it over 14 days. If successful, this approach could give patients a better chance of a full recovery.”
Under the agreement, Edge Therapeutics will lead and fund development and commercialization of NimoGel, as well as provide the scientific expertise of its co-founder and Chief Scientific Officer, R. Loch Macdonald, MD, PhD, a leading researcher on secondary brain injury. SurModics will provide technical and manufacturing expertise.
“There is a tremendous unmet medical need in treating brain injuries. Treatments available today are only minimally effective because the doses that can be tolerated by patients are too low to prevent certain types of delayed complications such as vasospasm, a type of stroke that is a leading cause of permanent brain damage or death after brain injury,” said Dr. Macdonald. “The NimoGel clinical development program is important because it has the potential to deliver high enough concentrations of nimodipine to the brain to prevent vasospasm and avoid the systemic side effects caused by oral nimodipine.”
SurModics has completed a major facility expansion at its site in Birmingham, Alabama. The agreement with Edge Therapeutics anticipates the use of this facility for the production of clinical materials and ultimately for commercial supply.
“The use of SurModics’ proprietary biodegradable drug delivery system is an ideal match in this clinical area, as generating high local drug levels is critical for achieving optimal clinical outcomes,” said Phil Ankeny, interim CEO of SurModics. “We look forward to a strong collaboration with Edge Therapeutics and to continuing in the development and commercialization of this important product for patients suffering a stroke or TBI.”
“We are thrilled to have SurModics as our development partner on NimoGel and believe that their technical experience, depth of capabilities, and world-class cGMP manufacturing facility make them an ideal partner to help us advance our research and development,” said Brian Leuthner, President and CEO of Edge Therapeutics.
Date: July 21, 2010
Source: Edge Therapeutics, Inc.
