Edge Therapeutics Receives European Commission Orphan Drug Designation for EG-1962 in the Treatment of Patients With Subarach...
October 12 2015 - 8:30AM
Edge Therapeutics, Inc. (Nasdaq:EDGE) today announced that the
European Commission (EC) has granted orphan drug
designation to EG-1962, its lead product candidate, which is
in development for treating patients that have suffered an
aneurysmal subarachnoid hemorrhage (aSAH), also known as a ruptured
brain aneurysm. The designation follows a positive opinion from the
European Medicine Agency (EMA) Committee for Orphan Medicinal
Products (COMP).
Orphan drug designation by the European Commission provides
regulatory and financial incentives for companies to develop and
market therapies that treat a life-threatening or chronically
debilitating condition affecting no more than five in 10,000
persons in the European Union (EU), and where no satisfactory
treatment is currently available. In addition to a 10-year period
of marketing exclusivity in the EU following product approval,
receiving orphan drug designation provides incentives for companies
seeking protocol assistance from the EMA during the product
development phase, and direct access to the centralized
authorization procedure.
“We are very pleased that the EC has recognized the potential of
EG-1962 to improve the outcome of patients that suffer a rupture
brain aneurysm. Ruptured brain aneurysms can cause sudden
catastrophic consequences for their victim and even with currently
available medical therapy, many patients continue to have a dire
long-term prognosis,” said Brian A. Leuthner, Edge’s President and
Chief Executive Officer. “Edge is committed to developing
innovative therapies for serious life-threatening
conditions that have the potential to fundamentally improve the
lives of patients and reduce the burden on the family these
conditions may cause.”
In June, the U.S. Food and Drug Administration (FDA) granted
orphan drug designation to EG-1962. Orphan drug designation is
granted for novel drugs or biologics to treat rare medical diseases
or conditions that affect less than 200,000 people in the United
States. The designation qualifies the sponsor for numerous
incentives including seven years of market exclusivity after the
drug's approval, tax credits for clinical research costs, and
application fee reductions.
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, Edge’s 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, Edge’s second product candidate, is being
evaluated as a potential prophylactic treatment in the management
of chronic subdural hematoma, to prevent recurrent bleeding on the
surface of the brain.
About EG-1962
EG-1962 is a novel polymeric nimodipine microparticle containing
nimodipine suspended in a diluent of hyaluronic acid that utilizes
Edge’s proprietary PrecisaTM development platform designed to
improve patient outcomes following aSAH. EG-1962 has been granted
orphan drug designation by the FDA for the treatment of patients
with aSAH.
About aSAH
An aneurysmal subarachnoid hemorrhage, or aSAH, is a brain
hemorrhage after which blood from a ruptured aneurysm enters the
subarachnoid space, the area between the middle and deepest
protective layers of the brain. Approximately 600,000 individuals
worldwide suffer an aSAH annually. In the US, approximately 35,000
aSAH patients, with an average age of 52, arrive alive at the
hospital each year, and approximately 75% of these patients die or
suffer permanent brain damage.
For additional information about Edge Therapeutics, please
visit www.edgetherapeutics.com.
Forward-Looking Statements
This press release and any statements of representatives and
partners of Edge Therapeutics, Inc. 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 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,” “intends,” “plans,” “potential” or similar
expressions. 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
factors (many of which are beyond Edge’s control).
Investor Contact:
Allison Wey
Edge Therapeutics, Inc.
Tel: 1-800-208-EDGE (3343)
Email: awey@edgetherapeutics.com
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