SurModics and Edge Therapeutics enter licensing agreement for drug delivery technology

SurModics, Inc. (Nasdaq: SRDX), a leading provider of drug delivery and surface modification technologies to the healthcare industry, and Edge Therapeutics, Inc., a specialty biopharmaceutical company that transforms proven, off-patent drugs into targeted, locally delivered therapies for neurological disorders, announced today that the companies have entered into a licensing agreement for drug delivery technology.

“SurModics' proprietary biodegradable drug delivery system is an ideal match for brain injury clinical applications, as generating high local drug levels is critical for achieving optimal clinical outcomes”

On July 21, 2010, Edge announced a feasibility collaboration with SurModics to develop a novel biodegradable, site-specific, sustained-release formulation (NimoGel™, EG-1961) for the potential treatment of delayed cerebral ischemia (DCI). DCI is a complication that often occurs hours to days following subarachnoid hemorrhage (SAH), which is typically the result of a ruptured brain aneurysm or head trauma.

Under the licensing agreement, Edge will lead and fund development and commercialization of the program. SurModics will provide Edge access to certain proprietary technologies as well as technical and manufacturing expertise at its cGMP facility in Birmingham, Alabama. SurModics will be eligible to receive licensing fees and milestone payments in the event of the successful development and commercialization of the product. SurModics will also receive royalties on product sales.

The license agreement covers NimoGel, Edge's lead drug program that combines the FDA-approved calcium channel blocker nimodipine and SurModics' proprietary biodegradable delivery system. NimoGel is designed to be delivered directly to the injury and is expected to provide consistent and appropriate local concentrations of nimodipine while minimizing systemic side effects.

"SurModics' proprietary biodegradable drug delivery system is an ideal match for brain injury clinical applications, as generating high local drug levels is critical for achieving optimal clinical outcomes," said Philip D. Ankeny, SurModics' interim chief executive officer, senior vice president and chief financial officer. "We are very impressed with the thought leaders and clinical advisors that Edge has assembled and the drive that Edge executives have demonstrated to rapidly advance this program. The promising data that our teams generated in the feasibility phase was a compelling reason for executing this licensing agreement. We look forward to continued progress in developing and commercializing this important product for patients suffering brain hemorrhages."

"We are excited to have SurModics as our development and commercialization partner on NimoGel given the company's technical experience, depth of capabilities, and world-class cGMP manufacturing facility," said Brian A. Leuthner, president and chief executive officer of Edge Therapeutics. "We are confident in our ability to advance our research and development and ultimately commercialize this potentially life-saving product."

"There is an urgent need for better treatments to address complications resulting from SAH. The current treatment, oral nimodipine, is only marginally effective in part because it fails to provide adequate drug concentrations at the injury site in the brain. Higher oral doses that may be more effective cause side effects outside the brain and are unsafe," said R. Loch Macdonald, M.D., co-founder and chief scientific officer of Edge Therapeutics. "Importantly, NimoGel has the potential to dramatically improve patient outcomes where other drugs have failed."