Edge Therapeutics Announces Commercial Supply Agreement for EG-1962 with Oakwood Laboratories
July 06 2017 - 6:30AM
Edge Therapeutics, Inc. (Nasdaq:EDGE) today announced that it has
entered into a supply agreement and an amended and restated
development agreement with Oakwood Laboratories for the commercial
manufacturing of EG-1962 for initial product launch and thereafter.
EG-1962, an orphan drug and Fast Track product designated by the
U.S. Food and Drug Administration (FDA), is currently in Phase 3
development for the treatment of aneurysmal subarachnoid hemorrhage
(aSAH).
“These new agreements are an important step in establishing the
supply of EG-1962 for potential commercialization, and we look
forward to expanding our relationship with Oakwood Laboratories,”
said Brian A. Leuthner, Edge’s President and Chief Executive
Officer. “We have been working with Oakwood for a period of time
from process development through the manufacturing of the EG-1962
clinical supply used in our ongoing NEWTON 2 Phase 3 clinical
study, and we were impressed by their capabilities in polymer-based
microparticles and their ability to meet our timelines.”
About EG-1962
EG-1962 is a novel polymeric microparticle containing nimodipine
suspended in a diluent of sodium hyaluronate. EG-1962 utilizes
Edge’s proprietary PrecisaTM development platform and is
designed to improve patient outcomes following aSAH. EG-1962,
administered through an EVD, is currently being studied in the
pivotal Phase 3 NEWTON 2 study. EG-1962 has been granted Fast Track
designation by the U.S. Food and Drug
Administration (FDA), and orphan drug designation by
the FDA and the European Commission.
About Edge Therapeutics, Inc.
Edge Therapeutics, Inc. is a clinical-stage biotechnology
company that discovers, develops and seeks to commercialize novel,
hospital-based therapies capable of transforming treatment
paradigms for the management of acute, life-threatening
neurological and other conditions. EG-1962, Edge’s lead product
candidate, has the potential to fundamentally improve patient
outcomes and transform the management of aneurysmal subarachnoid
hemorrhage, which is bleeding around the brain due to a ruptured
brain aneurysm. Edge is evaluating EG-1962 in two clinical studies:
a pivotal Phase 3 NEWTON 2 study of EG-1962 delivered via external
ventricular drain, and a study of direct intracisternal
administration of EG-1962. For additional information about Edge,
please visit www.edgetherapeutics.com.
Forward-Looking Statements
This press release and any statements of representatives of Edge
Therapeutics, Inc. related thereto that are not historical in
nature contain, or may contain, among other things, certain
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. These forward-looking
statements may include, without limitation, statements with respect
to Edge’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," “seeks,” "intends," "plans,"
"potential" or similar expressions, including statements with
respect to Edge’s future clinical plans, Edge’s ability to advance
its portfolio of therapies towards commercialization, Edge’s
manufacture and supply plans and relationships and the potential
effects of Edge’s products. These statements are based upon the
current beliefs and expectations of Edge’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 risk
factors (many of which are beyond Edge's control) as described
under the heading "Risk Factors" in Edge’s filings with the United
States Securities and Exchange Commission.
Investor Contact:
Gregory Gin
Edge Therapeutics, Inc.
Tel: 1-800-208 EDGE (3343)
Email: ggin@edgetherapeutics.com
Media Contact:
Laura Bagby
6 Degrees
Tel: 312-448-8098
Email: lbagby@6degreespr.com
EDGE THERAPEUTICS, INC. (NASDAQ:EDGE)
Historical Stock Chart
From Jun 2024 to Jul 2024
EDGE THERAPEUTICS, INC. (NASDAQ:EDGE)
Historical Stock Chart
From Jul 2023 to Jul 2024