NEW PROVIDENCE, NJ–(Marketwire – December 02, 2011) – Edge Therapeutics, Inc. announced today that the New Jersey Small Business Development Centers (NJSBDC) has named Edge a recipient of its 2011 Success Awards. The award recognizes companies and legislators for their commitment to the growth of small businesses representing a diverse array of industries including biotechnology, financial services, educational services, media and entertainment, food services and high-tech.

“Edge is a great example of what’s possible when talented and capable entrepreneurs apply their skills to a unique and innovative idea,” said Jerry Creighton, Sr., Executive Director of the NJIT-EDC and President of New Jersey Business Incubator Network. “The outcome is an emerging growth company! Everyone wins when you advance new scientific research.”

Edge Therapeutics is a hospital-focused biopharmaceutical company developing novel implantable technology for direct delivery of proven drugs to the site of brain injury. Edge began in 2009 as a New Jersey Institute of Technology Enterprise Development Center (NJIT-EDC) incubator company and has recently moved into its new commercial headquarters in New Providence, NJ.

“We are honored to be the recipient of a 2011 NJSBDC Success Award. It is a tremendous validation of the rapid progress we are making in developing life-saving therapies for civilians and soldiers that suffer brain hemorrhages,” said Brian Leuthner, President and Chief Executive Officer of Edge. “The New Jersey Small Business Development Centers along with the NJIT-EDC have been a vital resource for Edge as we grow.”

“Under the leadership of Brian Leuthner, Edge has grown rapidly with the support of non-dilutive partner funds and by securing equity financing,” noted Randy Harmon, New Jersey Small Business Development Centers Lead Technology Commercialization Consultant.

About Edge Therapeutics
Edge Therapeutics uses a novel, site-specific and sustained release-microparticle technology platform to deliver drugs to the brain and treat 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 and novel formulations of known active drugs for direct therapeutic delivery to the site of injury in the brain.

The company’s patent-protected, bioabsorbable microparticle formulations release drugs locally and consistently at therapeutic concentrations in the brain, which maximizes therapeutic activity while avoiding treatment-limiting systemic side effects seen with oral and intravenous delivery. 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. The lead products, NimoGel™ and NimoVent™, are microparticle formulations of the calcium channel blocker nimodipine. These drugs are being developed to prevent delayed complications after subarachnoid hemorrhage (where today oral- or i.v.-administered nimodipine is employed but in suboptimal concentrations due to the generation of systemic side effects). Phase 2 studies for both NimoGel and NimoVent are planned for 2012.

For more information on Edge Therapeutics, Inc., please visit www.edgetherapeutics.com.

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

Contact:

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

Founder of Celgene and 30-Plus Year Veteran of Biotechnology Industry Becomes Director

Newark, NJ – September 7, 2011 – Edge Therapeutics, Inc. announced today the appointment of Sol J. Barer, Ph.D., to its Board of Directors, effective September 1, 2011. Dr. Barer will also serve as chair of the Compensation Committee. Edge Therapeutics is a biopharmaceutical company developing novel implantable technology for direct delivery of proven therapeutic compounds to the site of brain injury.

Dr. Barer is a founder of Celgene Corporation and spent 18 years leading Celgene as president, COO and CEO, culminating with his tenure as Celgene’s executive chairman and chairman before retiring in June 2011. Under his helm, Celgene became the third largest independent biotechnology company in the world and a member of the S&P500 with a current market capitalization exceeding $25 billion.

“We are honored that Dr. Barer is joining our board during this exciting and early stage of our company’s development,” said Brian A. Leuthner, president and CEO of Edge. “Dr. Barer brings a commanding knowledge of biotechnology as both a scientist and a business leader. His remarkable success in developing life-saving and transformational products for patients in need will be an invaluable asset for Edge Therapeutics.”

“I look forward to helping Edge Therapeutics realize its full potential of advancing patient care and developing life-saving therapies for the treatment of brain hemorrhage,” said Dr. Barer.

About Edge Therapeutics

Edge Therapeutics is a hospital-focused biopharmaceutical company that uses a novel, site- specific and sustained release-microparticle technology platform to develop products for 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 and novel formulations of known active drugs for direct therapeutic delivery to the site of injury in the brain. The company’s patent-protected bioabsorbable microparticle formulations release drugs locally and consistently at therapeutic concentrations in the brain, which maximizes therapeutic activity while avoiding treatment-limiting systemic side effects seen with oral and intravenous delivery. The technology platform is the basis of Edge’s pipeline of drugs in therapeutic areas such as spontaneous brain hemorrhage, traumatic brain injury and brain surgery. The lead products, NimoGel and NimoVent, are microparticle formulations of the calcium channel blocker nimodipine. These drugs are being developed to prevent delayed complications after subarachnoid hemorrhage (where today oral- or i.v.-administered nimodipine is employed but in suboptimal concentrations due to the generation of systemic side effects). Phase 2 studies for both NimoGel and NimoVent are planned for 2012.

For more information on Edge Therapeutics, Inc., please visit www.edgetherapeutics.com.

Contact:

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

CEO Brian Leuthner to Present on September 13, 2011 at 12:05pm

Newark, NJ – September 7, 2011 – Edge Therapeutics, Inc., a biopharmaceutical company developing novel implantable technology for direct delivery of proven therapeutic compounds to the site of brain injury, will be a presenting company at the Rodman & Renshaw 13th Annual Healthcare Conference to be held in New York City from September 11-13, 2011 at the Waldorf-Astoria. Brian Leuthner, chief executive officer, is scheduled to present on Tuesday, September 13th, at 12:05 p.m. in the Metropolitan West conference room.

Mr. Leuthner will provide a brief overview of the company’s exciting product pipeline, its development status and upcoming milestones. In addition, Mr. Leuthner will be available for one-on-one meetings throughout the day, and interested parties may schedule meetings through their Rodman & Renshaw representative.

About Edge Therapeutics

Edge Therapeutics is a hospital-focused biopharmaceutical company that uses a novel, site-specific and sustained release-microparticle technology platform to develop products for 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 and novel formulations of known active drugs for direct therapeutic delivery to the site of injury in the brain. The company’s patent-protected bioabsorbable microparticle formulations release drugs locally and consistently at therapeutic concentrations in the brain, which maximizes therapeutic activity while avoiding treatment-limiting systemic side effects seen with oral and intravenous delivery. The technology platform is the basis of Edge’s pipeline of drugs in therapeutic areas such as spontaneous brain hemorrhage, traumatic brain injury and brain surgery. The lead products, NimoGel and NimoVent, are microparticle formulations of the calcium channel blocker nimodipine. These drugs are being developed to prevent delayed complications after subarachnoid hemorrhage (where today oral- or i.v.-administered nimodipine is employed but in suboptimal concentrations due to the generation of systemic side effects). Phase 2 studies for both NimoGel and NimoVent are planned for 2012.

For more information on Edge Therapeutics, Inc., please visit www.edgetherapeutics.com.

Contact:

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

Newark, NJ – February 11, 2011 – Edge Therapeutics announced today that NimoGel™, an investigational sustained-release medicine delivered directly to the brain, prevented delayed complications of sudden brain injury in a preclinical study. In an oral presentation today at the American Stroke Association’s International Stroke Conference, researchers reported that NimoGel effectively prevented cerebral vasospasm, the constriction of blood vessels in the brain, after subarachnoid hemorrhage (SAH), or sudden bleeding in the space between the middle lining of the brain and the brain itself, in a large-animal model. This was achieved by obtaining sufficient concentrations of drug at the site of injury and low enough concentrations in the blood to avoid complications. Cerebral vasospasm is a leading cause of permanent brain damage and death after brain injury.

“There is a tremendous unmet medical need in treating brain injuries. Treatments available today are only minimally effective in part because the systemically administered doses that can be tolerated by patients are too low to prevent certain types of delayed complications such as cerebral vasospasm,” said R. Loch Macdonald, MD, PhD, Keenan Endowed Chair and Head of the Division of Neurosurgery at St. Michael’s Hospital, University of Toronto and Chief Scientific Officer of Edge Therapeutics. “This preclinical study suggests that it is possible to achieve adequate and sustained concentrations of nimodipine locally and prevent cerebral vasospasm and other potentially deadly complications after brain injury. Based on these encouraging results in a large animal model, further evaluation of NimoGel in human clinical trials is warranted.”

Dr. Macdonald presented this research today in a session titled “Effect of site-specific, sustained-release nimodipine on vasospasm after subarachnoid hemorrhage in dogs.”  In this study, six dogs were randomized to receive placebo or 10 mg or 30 mg doses of NimoGel administered by intracranial injection. Thirty mg of NimoGel completely prevented vasospasm for up to 14 days after SAH. Seven days is the time when vasospasm peaks, and vasospasm typically resolves in 14 to 21 days. There were no untoward side effects such as hypotension or abnormal behavior, and no evidence of local brain inflammation on pathologic examination.

“We are very encouraged by these preclinical results and are planning to initiate a Phase 2 clinical trial in patients with ruptured brain aneurysms in 2012,” said Brian A. Leuthner, President and Chief Executive Officer of Edge Therapeutics. “This clinical data will help us determine the potential role of NimoGel in improving outcomes for patients with sudden brain injuries.”

About Cerebral Vasospasm

Cerebral vasospasm is a significant delayed complication and a leading cause of permanent brain damage and death following subarachnoid hemorrhage. Vasospasm occurs three to 14 days after subarachnoid hemorrhage and results in other blood vessels in the brain contracting, thereby limiting blood flow to vital areas of the brain. This reduced blood flow can cause a stroke or additional tissue damage.

About NimoGel™

NimoGel™, also known as EG-1961, is the lead development candidate in the Company’s pipeline of site-specific, sustained-release drug candidates being developed to prevent delayed complications following various types of spontaneous and traumatic brain hemorrhages. A locally delivered, sustained-release formulation of the generic calcium channel blocker nimodipine, NimoGel is designed to provide consistent and sufficiently high nimodipine concentrations in the brain to prevent the catastrophic condition of delayed cerebral ischemia while avoiding previous dose-limiting systemic side effects. Nimodipine microparticles are delivered during the surgery required to secure the bleeding aneurysm – or are administered minimally invasively when surgery is not required – so NimoGel use does not necessitate a special surgery or additional procedure.

Edge is developing NimoGel in collaboration with SurModics, a leading provider of drug delivery technologies. Under the terms of a licensing agreement announced by the companies in November 2010, Edge will lead and fund development commercialization of the program, and SurModics will provide Edge access to certain proprietary technologies as well as technical and manufacturing expertise.

About Edge Therapeutics

Edge Therapeutics is a privately held specialty biopharmaceutical company founded in 2009 and funded by private investors, the New Jersey Commission on Science and Technology and the New Jersey Economic Development Authority. Edge believes that local, sustained-release delivery of medicine directly to the injury site in the brain will improve patient outcome and reduce healthcare costs in unmet conditions in the central nervous system.  By repurposing and transforming well-established off-patent drugs, Edge streamlines the development path while drastically reducing both risk and cost.  Edge’s lead product, NimoGel, will soon enter into IND-enabling studies to improve patient outcome after subarachnoid hemorrhage. For more information on Edge Therapeutics, Inc., please visit www.edgetherapeutics.com.

Contact

Jennifer Devine

SmithSolve LLC

On behalf of Edge Therapeutics, Inc.

973-442-1555 ext 102