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Government of Canada Awards CA$700,000 Toward Phase 2 Study of Edge Therapeutics's Lead Compound to Improve Outcomes After Brain Injury  
6/11/2012 9:30:34 AM

NEW PROVIDENCE, NJ and TORONTO--(Marketwire - June 08, 2012) - Edge Therapeutics, Inc. and St. Michael's Hospital, an affiliate of the University of Toronto, announced today that the Government of Canada has awarded up to CA$700,000 to match equal expenditures by Edge for advancing a Phase 2 clinical trial of Edge's lead compound. This funding from the Federal Economic Development Agency for Southern Ontario (FedDev), administered through The Ontario Brain Institute (OBI), is part of an CA$11-million initiative to accelerate the commercialization of 14 innovative neurotechnology projects.

Edge, a clinical-stage, hospital-focused biopharmaceutical company, and St. Michael's Hospital, ranked third in academic impact among approximately 100 neurosurgery departments in North America(1), also announced today that they will collaborate on Phase 2 clinical testing of Edge's novel, site-specific and sustained-release nimodipine microparticle formulation (NimoVent™) that is designed to prevent delayed cerebral ischemia (DCI), a leading cause of permanent brain damage or death after brain injury.

"Today, patients with brain hemorrhage face life-threatening delayed complications, and only marginally effective treatment options are available," said R. Loch Macdonald, MD, PhD, Head of the Division of Neurosurgery, Keenan Endowed Chair in Surgery at St. Michael's Hospital and Chief Scientific Officer of Edge Therapeutics. "This research collaboration will allow us to further advance a much needed therapy."

"This novel partnership spanning academia, industry, and government will accelerate development of promising technologies and bring them to the market more quickly," said Dr. Arthur S. Slutsky, Vice-President of Research at St. Michael's Hospital.

"By collaborating with St. Michael's, Edge gains access to world-class experts in neurosurgery, established clinical research capabilities, and significant government funding. It also helps us fulfill our primary mission of saving lives," said Brian Leuthner, President and CEO of Edge Therapeutics.

(1) J Neurosurg. 2010 Sep;113(3):447-57. Academic impact and rankings of American and Canadian neurosurgical departments as assessed using the h index

About Edge Therapeutics

Edge Therapeutics is a clinical-stage, hospital-focused biopharmaceutical company that uses its novel, site-specific and sustained-release microparticle technology platform to deliver drugs to the brain for the treatment of acute, and fatal or debilitating neurological conditions that currently have no effective therapies. Edge works with some of the world's foremost scientists from leading academic research centers to develop proprietary formulations of known active drugs for direct therapeutic delivery to the site of injury in the brain.

The Company's patent-protected bio-absorbable microparticle formulations release drugs locally and consistently at therapeutic concentrations in the brain, with the objective of maximizing therapeutic activity and avoiding treatment-limiting systemic side effects seen with current treatments. Currently, oral- or i.v.-administered therapies are employed but in suboptimal concentrations due to the generation of systemic side effects. This technology platform is the basis of Edge's pipeline of drugs in therapeutic areas such as complications from spontaneous brain hemorrhage, traumatic brain injury and brain surgery. Edge's lead products, NimoVent™, EG-1964, and NimoGel™ are being developed to prevent various delayed complications after brain hemorrhage. NimoVent and NimoGel are different proprietary formulations of the generic calcium channel blocker nimodipine, while EG-1964 delivers a hemostatic agent. For more information on Edge Therapeutics, Inc., please visit: www.edgetherapeutics.com

About St. Michael's Hospital

St. Michael's Hospital provides compassionate care to all who enter its doors. The hospital also provides outstanding medical education to future health care professionals in more than 23 academic disciplines. Critical care and trauma, heart disease, neurosurgery, diabetes, cancer care, and care of the homeless are among the hospital's recognized areas of expertise. Through the Keenan Research Centre and the Li Ka Shing International Healthcare Education Center, which make up the Li Ka Shing Knowledge Institute, research and education at St. Michael's Hospital are recognized and make an impact around the world. Founded in 1892, the hospital is fully affiliated with the University of Toronto. For additional information about St. Michael's Hospital, please visit: www.stmichaelshospital.com

About FedDev Ontario

With a five-year mandate, the Federal Economic Development Agency for Southern Ontario (FedDev Ontario) was launched in August 2009 to help respond to Ontario's economic challenges. Through its funding initiatives, FedDev Ontario (www.feddevontario.gc.ca) is driving economic and community development, innovation, and economic diversification, while contributing to the success of communities, businesses, educational institutions and not-for-profit organizations. All of these activities contribute to FedDev Ontario's vision: a prosperous and globally competitive Ontario.

About the Ontario Brain Institute (OBI)

Launched in November 2010, the OBI has been established to become an internationally recognized centre of excellence in brain research, translation and innovation. It will achieve its vision by initiating, funding, promoting and stimulating brain research, education and training. The research outcomes will be translated into clinical applications and commercialization opportunities related to the prevention, early diagnosis, treatment and management of brain diseases and disorders. The Institute is an independent, not-for-profit corporation funded by the Government of Ontario. The OBI will serve as a nexus for collaborative efforts, with a program focused on bringing together Ontario's leading scientists and clinicians drawn from Ontario's universities, colleges, and hospitals. For additional information about the Ontario Brain Institute, please visit: http://www.braininstitute.ca


For more information contact:

Edge Therapeutics, Inc.
Brian A. Leuthner
President & CEO
800-208-EDGE

St. Michael's Hospital
Leslie Shepherd
Manager, Media Strategy
416-864-6094

Ontario Brain Institute
Lynn Butler
Manager
Government Relations & Strategic Communications
647-847-3136


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