NEWARK, NJ--(Marketwire - July 20, 2010) - Edge Therapeutics, Inc., a specialty pharmaceutical company focused on improving the delivery of life-saving medicines to the brain announced today that it has entered into a feasibility agreement with SurModics, Inc. (NASDAQ: SRDX), 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.
About Secondary Brain Damage
Secondary brain injury is an indirect result of a sudden brain injury (hemorrhagic stroke or TBI) that can damage neurons that were unharmed in the primary injury. While sudden brain injury results from processes initiated directly by the stroke or TBI, secondary brain injury occurs in the hours and days following the primary injury and plays a large role in the ultimate extent of brain damage and deaths. In sudden brain injury, 80% to 90% of victims survive the initial injury, but almost half suffer secondary brain damage in the days after the event.
Cerebral vasospasm is a leading delayed complication following aneurysmal subarachnoid hemorrhage or TBI. Vasospasm occurs 3-14 days after the subarachnoid hemorrhage and results in arteries in the brain contracting, thereby limiting blood flow to vital areas of the brain. This reduced blood flow can cause another stroke or additional tissue damage.
About NimoGel™ (EG-1961)
NimoGel consists of the FDA-approved calcium channel blocker nimodipine formulated in a proprietary biodegradable polymer designed to release the drug over 14 days. NimoGel is delivered directly to the site in the brain where it is needed, thus providing very high drug concentrations at the specific site at risk for life-threatening vasospasm while using 80% less drug than is currently administered systemically. Today's oral nimodipine therapy is minimally effective because dangerous side effects such as lowering of blood pressure limit the ability to achieve optimal drug concentrations in the brain.
About Edge Therapeutics
Edge Therapeutics is a privately held specialty pharmaceutical company located at the Enterprise Development Center Incubator on the campus of New Jersey Institute of Technology in Newark, NJ. The company was founded in 2009 and is supported by private investors, the New Jersey Commission on Science and Technology, and the New Jersey Economic Development Authority. Edge Therapeutics seeks to revolutionize treatment to prevent secondary brain damage after hemorrhagic stroke or TBI, by taking today's minimally effective off-patent drugs and delivering them directly to the brain via proprietary sustained-release formulations. The most advanced product, NimoGel™, consists of the generic calcium channel blocker nimodipine formulated in a biodegradable polymer carrier composed of FDA-approved materials. NimoGel™ is designed to be placed directly next to brain arteries after ruptured brain aneurysms or TBI to prevent vasospasm, a type of secondary stroke, and thereby improve patient outcomes. For more information on Edge Therapeutics, please visit www.edgetherapeutics.com.