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True relief with sustained release for largely unmet neurological problem
NEWARK, N.J.—Edge Therapeutics Inc., a specialty biopharmaceutical company that transforms proven, off-patent drugs into targeted, locally delivered therapies for neurological disorders, and SurModics Inc., a provider of drug delivery and surface modification technologies, announced in early November an exclusive worldwide licensing agreement to develop a biodegradable, site-specific, sustained-release formulation (NimoGel, EG-1961) for the potential treatment of delayed cerebral ischemia (DCI).
The relationship goes back to July, when Edge announced a feasibility collaboration with Eden Prairie, Minn.-based SurModics to develop a drug delivery technology for addressing DCI, 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. Brian A. Leuthner, president and CEO of Edge Therapeutics, cites SurModics' technical experience, depth of capabilities and world-class cGMP manufacturing facility as key reasons for choosing it as a collaborator.
"We believe that locally delivered, sustained release brought directly to the site of brain injury will prevent certain complications," notes Leuthner. "There are a number of well-verified unmet medical needs in central nervous system indications where something like a oral drug just doesn't cut the mustard because of the blood brain barrier or other issues. We were looking for a partner who could help us take well-proven off- patent drugs and make them locally delivered, and that partner was SurModics."
Under the agreement, Edge Therapeutics will lead and fund development and commercialization of the program, while SurModics will provide Edge access to certain proprietary technologies as well as technical and manufacturing expertise at its cGMP facility in Birmingham, Ala.
Although specific terms of the deal were not released, the companies do note that SurModics will be eligible to receive licensing fees and milestone payments in the event of the successful development and commercialization of the product, as well as royalties on product sales.
The license agreement covers NimoGel, Edge Therapeutics' 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, Leunther says, adding, "We are confident in our ability to advance our research and development and ultimately commercialize this potentially life-saving product."
"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," says Philip D. Ankeny, SurModics' interim CEO, 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."
The need for a formulation like this to address complications resulting from SAH is urgent, Leunther says, because the current treatment, oral nimodipine, is only marginally effective, failing 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," adds Dr. R. Loch Macdonald, co-founder and chief scientific officer of Edge Therapeutics. "Importantly, NimoGel has the potential to dramatically improve patient outcomes where other drugs have failed."
Following SAH, brain neurons die acutely due to trauma and lack of blood flow; however, even greater neuronal damage may occur in the first several weeks following SAH due to DCI. DCI is caused by a series of biochemical processes that occur hours to days after SAH, which Leunther says provides a unique opportunity to initiate protective therapy while the patient is hospitalized and under the care of a neurosurgeon and prior to the onset of secondary injury. The time- dependent progression of damage presents a window of opportunity to prevent DCI; however despite substantial research and clinical efforts with oral and intravenous therapies, DCI continues to cause irreversible brain injury and remains a significant contributor to death and disability.
A particularly notable characteristic of focusing on NimoGel, Leunther says, is that the compound is delivered during surgery required to secure the bleeding artery, so NimoGel administration does not require a special surgery or an additional procedure to administer.