BERKELEY HEIGHTS & PARSIPPANY, N.J.--(BUSINESS WIRE)--Clinical-stage biotechnology company Edge Therapeutics, Inc. and leading specialty chemicals company Evonik Corporation announced today that they have received a U.S. Patent No. 8,821,944 (the ‘944 patent) expiring July 2033 covering EG-1962, Edge’s lead product candidate in development to potentially improve patient outcome after a ruptured brain aneurysm.
The ‘944 patent includes claims that cover compositions containing the Form I polymorph of nimodipine, methods of manufacturing, and methods of use for EG-1962.
“We are pleased that the U.S. Patent and Trademark Office (USPTO) has issued this composition of matter patent, which builds upon our existing intellectual property portfolio for EG-1962,” said Brian Leuthner, Chief Executive Officer and President of Edge Therapeutics, Inc. “Together with our partners at Evonik, we are developing EG-1962 to improve patient outcomes in this vulnerable patient population.”
Edge is currently conducting the Phase 1/2 NEWTON study, evaluating the safety, tolerability and pharmacokinetics of EG-1962 compared to oral nimodipine, the current standard of care, in patients with aneurysmal subarachnoid hemorrhage. EG-1962 allows delivery of nimodipine directly to the site of injury in the brain through a single administration with a sustained drug exposure for 21 days. Evonik manufactures EG-1962 and other clinical materials at its Birmingham, Ala. site, using its proprietary FormEZE® microparticle technology and Resomer® Select biomaterials.
“We are pleased to partner with Edge Therapeutics for this important project that aims to treat patients suffering from aneurysms and improve their recovery,” said Jean-Luc Herbeaux, Head of Evonik’s Global Health Care Business Line. “Evonik is always excited to embark on new treatments that can revolutionize modern-day medicine. Our global network of experts and research and manufacturing facilities offer a vast array of technologies and competencies that can bring concepts to life and support such ventures.”
EG-1962 is a novel polymeric nimodipine microparticle that is administered directly into the brain. A single dose of EG-1962, administered initially at the time of aneurysm repair delivers a high concentration of nimodipine directly to the brain, with sustained drug exposure over 21 days. EG-1962 utilizes Edge’s proprietary, programmable, biodegradable polymer-based development platform, known as Precisa™. The Precisa™ platform allows Edge to create therapeutics capable of delivering medicines directly to the site of injury, providing a delivery mechanism that enables targeted and sustained drug exposure while potentially avoiding the systemic, dose-limiting side effects often associated with current standards of care. EG-1962 is currently being evaluated in the Phase 1/2 NEWTON study, a safety, tolerability and pharmacokinetics clinical trial.
About Edge Therapeutics, Inc.
Edge Therapeutics is a clinical-stage biotechnology company that discovers, develops and seeks to commercialize novel, hospital-based therapies capable of transforming treatment paradigms in the management of acute, life-threatening neurological conditions. EG-1962, our lead product candidate, has the potential to fundamentally improve patient outcomes and transform the management of aneurysmal subarachnoid hemorrhage, or aSAH, which is bleeding around the brain due to a ruptured brain aneurysm. EG-1964, our second product candidate, is being evaluated as a potential prophylactic treatment in the management of chronic subdural hematoma (cSDH), to prevent recurrent bleeding on the surface of the brain.
For additional information about Edge Therapeutics, please visit www.edgetherapeutics.com
About Evonik Industries AG
Evonik, the creative industrial group from Germany, is one of the world leaders in specialty chemicals. Profitable growth and a sustained increase in the value of the company form the heart of Evonik’s corporate strategy. Its activities focus on the key megatrends health, nutrition, resource efficiency and globalization. Evonik benefits specifically from its innovative prowess and integrated technology platforms.
Evonik is active in over 100 countries around the world. In fiscal 2013 more than 33,500 employees generated sales of around €12.7 billion and an operating profit (adjusted EBITDA) of about €2.0 billion.
For additional information about Evonik in North America, please visit our website: www.evonik.com/north-america
In so far as forecasts or expectations are expressed in this press release or where our statements concern the future, these forecasts, expectations or statements may involve known or unknown risks and uncertainties. Actual results or developments may vary, depending on changes in the operating environment. Neither Evonik Industries AG nor its group companies assume an obligation to update the forecasts, expectations or statements contained in this release.
This press release and any statements of representatives and partners of Edge Therapeutics, Inc. (the “Company”) related thereto contain, or may contain, among other things, certain “forward-looking statements” as defined in the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential” or similar expressions. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks and uncertainties. Actual results may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company’s control). Neither the Company, Evonik Industries AG nor its group companies assume an obligation to update the forecasts, expectations or statements contained in this press release.