Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the
“Company”) and Enalare Therapeutics Inc. (“Enalare”) today
announced that Enalare has secured a contract for up to $50.3
million from the Biomedical Advanced Research and Development
Authority (“BARDA”), part of the Administration for Strategic
Preparedness and Response in the U.S. Department of Health and
Human Services (contract number 75A50122C00072). In partnership
with BARDA, ENA-001 is being developed in an intramuscular (“IM”)
formulation for potential use in patients experiencing community
drug overdose and as a potential medical countermeasure for mass
casualty events.
The contract is awarded in stages based on the achievement of
established milestones and deliverables and provides funding for
Enalare to perform pre-clinical toxicology studies, human clinical
studies, drug and device manufacturing, and submission of the
regulatory file to the U.S. Food and Drug Administration (“FDA”)
for a formulation of ENA-001 suitable for community use. The first
phase of the contract, which provides approximately $6.0 million to
complete activities through the initial Phase 1 study, coincides
with grant support from the National Institute on Drug Abuse
(“NIDA”), part of the National Institutes of Health.
“Respiratory depression can be life threatening. This award
provides critical non-dilutive funding to Enalare to accelerate the
development of an IM formulation for ENA-001, which could
potentially enable more rapid deployment in emergency situations.
The pre-clinical work is going very well, and the BARDA contract
provides support along the development and regulatory pathway
toward FDA approval of ENA-001 for use in the United States. We
believe this is a promising opportunity to address a serious, unmet
issue in our society, and adds further to our enthusiasm for our
agreement with Enalare,” stated Scott Tarriff, President and Chief
Executive Officer of Eagle Pharmaceuticals.
“We are pleased to expand our partnership with BARDA on the
development of ENA-001 – a novel compound with a unique mechanism
of action as an agnostic respiratory stimulant,” said Herm Cukier,
President and CEO of Enalare Therapeutics. “ENA-001's rapid and
proven ventilatory stimulation, irrespective of the cause of the
respiratory depression, is critical for effective post-exposure
therapy given the urgency for treatment and the unknowns associated
with many chemical threats. Drug overdoses continue to ravage our
communities, and with this new contract, we can accelerate our
efforts to achieve our mutual goal of developing an innovative and
rapid treatment for respiratory depression in a variety of
settings,” concluded Cukier.
The new award builds on an existing partnership between Enalare
and the BARDA DRIVe ReDIRECT (Repurposing Drugs in Response to
Chemical Threats) program. During that project, Enalare performed
work to develop a formulation of ENA-001 that is suitable for
intramuscular administration, which is much preferred for emergency
use in the community.
The funding is provided via Biomedical Advanced Research and
Development Authority to support the advanced research and
development of medical countermeasures (MCM) for chemical,
biological, radiological and nuclear (CBRN) agents, pandemic
influenza, and emerging infectious diseases that threaten the U.S.
civilian population.
In August 2022, Eagle made an equity investment of $12.5 million
in Enalare, with a commitment to invest another $12.5 million six
months later and two potential follow-on equity investments of $15
million each contingent upon (i) the commencement of the ENA-001
Phase 2 clinical trial, and (ii) the ENA-001 Phase 2 clinical trial
reaching 50% enrollment. Eagle also has the option to acquire the
remaining Enalare shares for an aggregate purchase price ranging
from $100-$175 million plus royalty rights ranging from 9%-12% on
all future global net sales of any Enalare product, paid to the
ex-Eagle holders of Enalare shares at the time of acquisition.
The development of ENA-001 is also supported by the National
Institute on Drug Abuse (“NIDA”) of the National Institutes of
Health (“NIH”) under award number R44DA057133. The content of this
document is the responsibility of its authors and does not
necessarily represent the official views of the National Institutes
of Health.
About ENA-001
Enalare’s lead compound, ENA-001, is a one-of-a-kind new
chemical entity (NCE) designed as an agnostic respiratory
stimulant. The compound has a novel mechanism of action that
affects ventilation via the peripheral chemoreceptor pathways in
the carotid body. It utilizes the body’s own ventilation control
system to beneficially influence breathing and has been shown to be
effective and well tolerated in five human studies to date. With
its novel mechanism of action and based on findings to date, it
could potentially improve the lives of those impacted by several
life-threatening conditions, including community drug overdose,
post-operative respiratory depression, and apnea of prematurity.
ENA-001 is an investigational compound and is not approved for use
by the FDA.
About Enalare Therapeutics Inc.
Enalare Therapeutics Inc. is a clinical-stage biopharmaceutical
company dedicated to developing novel therapies for patients
suffering from life-threatening acute respiratory and critical care
conditions, including community drug overdose, post-operative
respiratory depression, and apnea of prematurity. Enalare maintains
global rights to its novel compounds and intends to start
additional clinical trials with ENA-001 for several indications in
the near term.
About Eagle Pharmaceuticals, Inc.
Eagle is a fully integrated pharmaceutical company with research
and development, clinical, manufacturing and commercial expertise.
Eagle is committed to developing innovative medicines that result
in meaningful improvements in patients’ lives. Eagle’s
commercialized products include vasopressin, PEMFEXY®, RYANODEX®,
BENDEKA®, BELRAPZO®, TREAKISYM® (Japan), and BYFAVO® and BARHEMSYS®
through its wholly owned subsidiary Acacia Pharma Inc. Eagle’s
oncology and CNS/metabolic critical care pipeline includes product
candidates with the potential to address underserved therapeutic
areas across multiple disease states. Additional information is
available on Eagle’s website at www.eagleus.com.
Forward-Looking StatementsThis press release
contains “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995, as amended, and
other securities law. Forward-looking statements are statements
that are not historical facts. Words and phrases such as
“anticipated,” “forward,” “will,” “would,” “may,” “remain,”
“potential,” “prepare,” “expected,” “believe,” “plan,” “near
future,” “belief,” “guidance,” and similar expressions are intended
to identify forward-looking statements. These statements include,
but are not limited to, statements with respect to the development
of, potential benefits of and potential FDA submission for ENA-001,
including a potential IM formulation that could potentially enable
more rapid deployment in emergency situations and the potential to
develop an innovative and rapid treatment for respiratory
depression in a variety of settings; expectations with respect to
the BARDA award providing funding to Enalare to accelerate the
development of ENA-001, including the potential receipt of
contingent funding from BARDA by Enalare; the achievement of
milestones and deliverables; the potential further investment by
Eagle in Enalare; and Eagle’s development programs, products and
pipeline. All of such statements are subject to certain risks and
uncertainties, many of which are difficult to predict and generally
beyond the Company’s or Enalare’s control, that could cause actual
results to differ materially from those expressed in, or implied or
projected by, the forward-looking information and statements. Such
risks and uncertainties include, but are not limited to: the
impacts of the ongoing COVID-19 pandemic, including interruptions
or other adverse effects on clinical trials and delays in
regulatory review or further disruption or delay of any pending or
future litigation; delay in or failure to obtain regulatory
approval of the Company's or Enalare’s product candidates and
successful compliance with FDA, European Medicines Agency and other
governmental regulations applicable to product approvals; the
outcome of litigation involving any of its products or that may
have an impact on any of its products; the strength and
enforceability of the Company’s intellectual property rights or the
rights of third parties; the risks inherent in drug development and
in conducting clinical trials; the ability of Enalare to achieve
milestones and deliverables under the BARDA agreement and otherwise
accelerate and achieve successful results in the development of
ENA-001; and those risks and uncertainties identified in the “Risk
Factors” sections of the Company's Annual Report on Form 10-K for
the year ended December 31, 2021, filed with the Securities and
Exchange Commission (the “SEC”) on March 8, 2022, the Company’s
Quarterly Report on Form 10-Q for the quarter ended March 31, 2022,
filed with the SEC on May 9, 2022, the Company’s Quarterly Report
on Form 10-Q for the quarter ended June 30, 2022, filed with the
SEC on August 9, 2022 and its other subsequent filings with the
SEC, which the Company expects to file with the SEC on August 9,
2022. Readers are cautioned not to place undue reliance on these
forward-looking statements. All forward-looking statements
contained in this press release speak only as of the date on which
they were made. Except to the extent required by law, the Company
undertakes no obligation to update such statements to reflect
events that occur or circumstances that exist after the date on
which they were made.
Investor Relations for Eagle Pharmaceuticals,
Inc.:
Lisa M. WilsonIn-Site Communications, Inc. T: 212-452-2793 E:
lwilson@insitecony.com
Important Safety Information for BYFAVO™
(remimazolam)
Injection
Indications
BYFAVO is a benzodiazepine indicated for the induction and
maintenance of procedural sedation in adults undergoing procedures
lasting 30 minutes or less.
Important Safety Information
WARNING: PERSONNEL AND EQUIPMENT FOR MONITORING AND
RESUSCITATION AND RISKS FROM CONCOMITANT USE WITH OPIOID
ANALGESICS
Personnel and Equipment for Monitoring and
Resuscitation
- Only personnel trained in
the administration of procedural sedation, and not involved in the
conduct of the diagnostic or therapeutic procedure, should
administer BYFAVO.
- Administering personnel must
be trained in the detection and management of airway obstruction,
hypoventilation, and apnea, including the maintenance of a patent
airway, supportive ventilation, and cardiovascular
resuscitation.
- BYFAVO has been associated
with hypoxia, bradycardia, and hypotension. Continuously monitor
vital signs during sedation and during the recovery
period.
- Resuscitative drugs, and
age- and size-appropriate equipment for bag-valve-mask–assisted
ventilation must be immediately available during administration of
BYFAVO.
Risks From Concomitant Use With Opioid Analgesics and
Other Sedative-Hypnotics
Concomitant use of benzodiazepines, including BYFAVO,
and opioid analgesics may result in profound sedation, respiratory
depression, coma, and death. The sedative effect of intravenous
BYFAVO can be accentuated by concomitantly administered CNS
depressant medications, including other benzodiazepines and
propofol. Continuously monitor patients for respiratory depression
and depth of sedation.
Contraindication
BYFAVO is contraindicated in patients with a history of severe
hypersensitivity reaction to dextran 40 or products containing
dextran 40.
Personnel and Equipment for Monitoring and
Resuscitation
Clinically notable hypoxia, bradycardia, and hypotension were
observed in Phase 3 studies of BYFAVO. Continuously monitor vital
signs during sedation and through the recovery period. Only
personnel trained in the administration of procedural sedation, and
not involved in the conduct of the diagnostic or therapeutic
procedure, should administer BYFAVO. Administering personnel must
be trained in the detection and management of airway obstruction,
hypoventilation, and apnea, including the maintenance of a patent
airway, supportive ventilation, and cardiovascular resuscitation.
Resuscitative drugs, and age- and size-appropriate equipment for
bag-valve-mask–assisted ventilation must be immediately available
during administration of BYFAVO. Consider the potential for
worsened cardiorespiratory depression prior to using BYFAVO
concomitantly with other drugs that have the same potential (e.g.,
opioid analgesics or other sedative-hypnotics). Administer
supplemental oxygen to sedated patients through the recovery
period. A benzodiazepine reversal agent (flumazenil) should be
immediately available during administration of BYFAVO.
Risks From Concomitant Use With Opioid Analgesics and
Other Sedative-Hypnotics
Concomitant use of BYFAVO and opioid analgesics may result in
profound sedation, respiratory depression, coma, and death. The
sedative effect of IV BYFAVO can be accentuated when administered
with other CNS depressant medications (eg, other benzodiazepines
and propofol). Titrate the dose of BYFAVO when administered with
opioid analgesics and sedative-hypnotics to the desired clinical
response. Continuously monitor sedated patients for hypotension,
airway obstruction, hypoventilation, apnea, and oxygen
desaturation. These cardiorespiratory effects may be more likely to
occur in patients with obstructive sleep apnea, the elderly, and
ASA-PS class III or IV patients.
Hypersensitivity Reactions
BYFAVO contains dextran 40, which can cause hypersensitivity
reactions, including rash, urticaria, pruritus, and anaphylaxis.
BYFAVO is contraindicated in patients with a history of severe
hypersensitivity reaction to dextran 40 or products containing
dextran 40.
Neonatal Sedation
Use of benzodiazepines during the later stages of pregnancy can
result in sedation (respiratory depression, lethargy, hypotonia) in
the neonate. Observe newborns for signs of sedation and manage
accordingly.
Pediatric Neurotoxicity
Published animal studies demonstrate that anesthetic and
sedation drugs that block NMDA receptors and/or potentiate GABA
activity increase neuronal apoptosis in the developing brain and
result in long-term cognitive deficits when used for longer than 3
hours. The clinical significance of this is not clear. However, the
window of vulnerability to these changes is believed to correlate
with exposures in the third trimester of gestation through the
first several months of life but may extend out to approximately 3
years of age in humans.
Anesthetic and sedation drugs are a necessary part of the care
of children needing surgery, other procedures, or tests that cannot
be delayed, and no specific medications have been shown to be safer
than any other. Decisions regarding the timing of any elective
procedures requiring anesthesia should take into consideration the
benefits of the procedure weighed against the potential risks.
Adverse Reactions
The most common adverse reactions reported in >10% of
patients (N=630) receiving BYFAVO 5-30 mg (total dose) and
undergoing colonoscopy (two studies) or bronchoscopy (one study)
were: hypotension, hypertension, diastolic hypertension, systolic
hypertension, hypoxia, and diastolic hypotension.
Use in Specific Populations
Pregnancy
There are no data on the specific effects of BYFAVO on
pregnancy. Benzodiazepines cross the placenta and may produce
respiratory depression and sedation in neonates. Monitor neonates
exposed to benzodiazepines during pregnancy and labor for signs of
sedation and respiratory depression.
Lactation
Monitor infants exposed to BYFAVO through breast milk for
sedation, respiratory depression, and feeding problems. A lactating
woman may consider interrupting breastfeeding and pumping and
discarding breast milk during treatment and for 5 hours after
BYFAVO administration.
Pediatric Use
Safety and effectiveness in pediatric patients have not been
established. BYFAVO should not be used in patients less than 18
years of age.
Geriatric Use
No overall differences in safety or effectiveness were observed
between these subjects and younger subjects. However, there is a
potential for greater sensitivity (eg, faster onset, oversedation,
confusion) in some older individuals. Administer supplemental doses
of BYFAVO slowly to achieve the level of sedation required and
monitor all patients closely for cardiorespiratory
complications.
Hepatic Impairment
In patients with severe hepatic impairment, the dose of BYFAVO
should be carefully titrated to effect. Depending on the overall
status of the patient, lower frequency of supplemental doses may be
needed to achieve the level of sedation required for the procedure.
All patients should be monitored for sedation-related
cardiorespiratory complications.
Abuse and Dependence
BYFAVO is a federally controlled substance (CIV) because it
contains remimazolam which has the potential for abuse and physical
dependence.
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