Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the
“Company”), and Enalare Therapeutics Inc (“Enalare”) today
announced an agreement for Eagle to make an equity investment of
$25 million in Enalare, a clinical-stage privately held
biopharmaceutical company dedicated to developing novel therapies
for patients suffering from life-threatening acute respiratory and
critical care conditions. The investment also includes an exclusive
option for Eagle to acquire all remaining issued and outstanding
Enalare stock upon the achievement of development milestones as set
forth in the agreement.
As part of the transaction, Eagle will invest up to
approximately $55 million, which is expected to occur over the next
two years subject to the achievement by Enalare of certain
milestones on an agreed upon timeline. The investment consists of
an upfront investment of $25 million, $12.5 million now and $12.5
to be paid in six months, 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 and
Enalare have also entered into an agreement providing Eagle the
option to acquire the all 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 transaction is expected to provide Eagle with products
protected by intellectual property rights, including composition of
matter patents, which potentially provide patent term into the
mid-2030s to the early 2040s. The Company believes these products
have the potential to address significant unmet medical needs for
millions of patients worldwide suffering from acute respiratory
depression, including those in the hospital post-operative care
setting, those experiencing community drug overdose, and preterm
infants suffering a common condition known as Apnea of
Prematurity.
- Enalare’s lead compound, ENA-001, is
an investigational, one-of-a-kind NCE designed as an agnostic
respiratory stimulant.
- It has been shown to be well
tolerated in restoring breathing drive and responsiveness in five
Phase 1 human studies.
- Recent topline results of Enalare’s
Phase 1 Study 108 indicate that ENA-001 successfully achieved the
study’s primary endpoint. It was shown to be safe and
well-tolerated and was able to reverse propofol-induced dampening
of ventilatory responsiveness in the population
studied.
- Enalare is planning to initiate a
Phase 2 clinical study for use in this patient population in the
near term.
- Approval for post-operative
respiratory depression expected in 2026, and community drug
overdose thereafter.
- ENA-001 is also being developed in
an Intramuscular (“IM”) Formulation in partnership with the
Biomedical Advanced Research and Development Authority (“BARDA”)
(contract number 75A50121C00044) for the potential use in patients
experiencing drug overdose in a community setting and as a
potential medical countermeasure for mass casualty events. This
effort is also supported via a grant from the National Institute on
Drug Abuse (NIDA: award number R44DA057133), a division of the
National Institutes of Health. Enalare is planning to complete the
required preclinical activities with the IM formulation in the near
term and to begin human clinical studies in the first half of next
year.
- In addition, Enalare is developing
ENA-001 for the treatment of Apnea of Prematurity (“AoP”), a
condition commonly affecting infants born preterm in which they
experience shallow or intermittent stoppage of breathing.
Persistent AoP can cause near- and long- term neurological
development risks to the infant. ENA-001 has received Rare
Pediatric Disease designation from the U.S. Food and Drug
Administration (“FDA”) in the treatment of AoP, which potentially
provides for a priority review voucher if the product is approved
for this indication. Enalare is currently executing an animal
proof-of-concept study with ENA-001 in the treatment of AoP and
expects to further pursue orphan drug designation and initiate
human clinical trials.
“By adding Enalare’s highly differentiated and complementary NCE
to our portfolio, we immediately expand Eagle’s long-term growth
possibilities. We believe ENA-001 has enormous potential to address
important unmet medical needs. It is an agnostic respiratory
stimulant with what we view as compelling clinical and health
economic value propositions. It is also an ideal fit within our
current hospital critical care portfolio, comprised of four
approved and two investigational products. BARHEMSYS®, the only
proven antiemetic for the treatment of post-operative nausea and
vomiting (“PONV”), BYFAVO®5, the first new drug approved for
procedural sedation in decades, RYANODEX®, and vasopressin are all
in market. If approved, landiolol, an ultra-short acting
cardio-selective IV beta-blocker, and CAL02, a first-in-class
anti-infective agent to treat severe bacterial pneumonia will join
our currently approved products to create a formidable
hospital/anesthesia product portfolio,” stated Scott Tarriff,
President and Chief Executive Officer of Eagle Pharmaceuticals.
“We plan to leverage our strong balance sheet and usher ENA-001
toward a potential 2026 launch. This is a great opportunity for
Eagle and one that furthers our transformation into a diversified,
branded pharmaceutical company with long-duration assets in acute
care,” concluded Tarriff.
“This partnership is an exciting step forward in the development
of ENA-001 and for the millions of patients worldwide that can
benefit from such a novel agnostic respiratory stimulant,” stated
Herm Cukier, President and CEO of Enalare Therapeutics. “Our
partnership with Eagle provides us access to capital and a robust
infrastructure and commercial platform to develop and potentially
launch our product. Without added headcount or expense, Eagle will
be able to rely on our experienced and highly regarded team as we
move onto Phase 2 and 3 trials, which we believe will successfully
demonstrate ENA-001's ability to improve patient respiratory
capacity. We look forward to a close and productive working
relationship and supporting Eagle in the successful development of
Enalare’s products,” concluded Cukier.
________________________5 https://bynder.acaciapharma.com/m/403e8c343b2922de/original/Byfavo-PI.pdf
Transaction Rationale
- Enalare’s intellectual property with
potential patent duration through the mid 2030s to early 2040s
offers Eagle access to complementary and diversified revenue
streams;
- Eagle believes there is a compelling
commercial opportunity for Enalare’s lead drug candidate, ENA-001:
- Agnostic respiratory stimulant with
first-in-class mechanism of action;
- Studied in more than 100 human
subjects to date;
- Differentiated product that
significantly expands long-term sales potential and durability of
Eagle’s hospital business;
- Synergistic fit with Eagle’s current
and expanding portfolio of hospital products, with overlap of
customer channel and decision makers;
- Timing of launch, if approved,
aligns with anticipated Eagle commercial capacity;
- Provides the
opportunity for strategic expansion into adjacent therapeutic and
customer channels.
About ENA-001
ENA-001 is an investigational new chemical entity (“NCE”) being
developed by Enalare for multiple potential indications, including
the prevention and treatment of post-operative respiratory
depression. 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. If approved, ENA-001 would offer new treatment options
for physicians, emergency responders, and caregivers addressing
acute respiratory depression across multiple patient populations in
multiple settings.
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.
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 Statements
This 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,” “could,”
“should,” “may,” “remain,” “potential,” “prepare,” “expected,”
“believe,” “plan,” “near future,” “belief,” “guidance,” “estimate,”
and similar expressions are intended to identify forward-looking
statements. These statements include, but are not limited to,
statements regarding future events such as statements regarding:
any further investments in Enalare and Enalare’s development
programs; expectations with respect to synergies; expectations that
the transaction with Enalare will help improve the care of patients
undergoing medical treatments, solidify the Eagle's leadership
position in the hospital and anesthesia space and bring long-term
value to Eagle's shareholders; expectations with respect to the
achievement of development milestones and any further investments
by Eagle in Enalare; estimated addressable market size and
estimated sales figures; Eagle’s marketing, product development,
partnering and growth strategy, including relating to the
commercialization of BARHEMSYS and BYFAVO and other products and
product candidates and Eagle’s ability to expand the application of
ENA-001, BARHEMSYS and BYFAVO; anticipated timelines of development
programs, including with respect to ENA-001; the timing, scope or
likelihood and timing of regulatory filings and approvals for
Eagle’s and Enalare’s product candidates, including ENA-001 and
landiolol; the ability of ENA-001, BARHEMSYS, BYFAVO, landiolol and
other products and product candidates to address unmet clinical
needs; the potential market opportunity for products or product
candidates, including for BARHEMSYS, BYFAVO, landiolol and ENA-001;
expectations regarding expansion of the Company’s product
portfolio, including with respect to the intellectual property of
Enalare and any potential future transactions; the ability of
Eagle’s executive team to execute on Eagle’s strategy and build
stockholder value; the ability of Eagle’s sales force to
commercialize products; expectations regarding Eagle’s future
growth and the expansion of Eagle’s growth possibilities as a
result of the Enalare transaction; and the ability of the Company’s
product candidates to deliver value to stockholders. All of such
statements are subject to certain risks and uncertainties, many of
which are difficult to predict and generally beyond the Company’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 risk that the anticipated benefits of
Eagle’s recently completed transaction with Acacia Pharma and the
transaction with Enalare are not realized; the impacts of the
COVID-19 pandemic and geopolitical events such as the conflict in
Ukraine, including disruption or impact in the sales of Eagle’s
marketed products, interruptions or other adverse effects to
clinical trials, delays in regulatory review, manufacturing and
supply chain interruptions, adverse effects on healthcare systems,
disruption in the operations of the Company’s third party partners
and disruption of the global economy, and the overall impact of the
COVID-19 pandemic or other events on Eagle’s business, financial
condition and results of operations; macroeconomic conditions, such
as rising inflation and uncertain credit and financial markets;
whether Eagle will incur unforeseen expenses or liabilities or
other market factors; whether Eagle will successfully implement its
development plan for its product candidates; delay in or failure to
obtain regulatory approval of Eagle’s or its partners’ product
candidates, including landiolol and ENA-001; whether Eagle can
successfully market and commercialize its products or product
candidates; the success of Eagle’s relationships with its partners;
the availability and pricing of third party sourced products and
materials; the outcome of litigation involving any of its products
or that may have an impact on any of Eagle’s products; successful
compliance with the FDA and other governmental regulations
applicable to product approvals, manufacturing facilities, products
and/or businesses; general economic conditions, including the
potential adverse effects of public health issues, including the
COVID-19 pandemic and geopolitical events, on economic activity and
the performance of the financial markets generally; the strength
and enforceability of Eagle’s intellectual property rights or the
rights of third parties; competition from other pharmaceutical and
biotechnology companies and the potential for competition from
generic entrants into the market; the risks inherent in the early
stages of drug development and in conducting clinical trials; and
factors in addition to the foregoing that may impact Eagle’s
financial projects and guidance, including among other things, any
potential business development transactions, acquisitions,
restructurings or legal settlements, in addition to any
unanticipated factors, that may cause Eagles actual results and
outcomes to materially differ from its projections and guidance;
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, Eagle’s Quarterly Report
on Form 10-Q for the quarter ended March 31, 2022, filed with the
SEC on May 9, 2022, and its other subsequent filings with the SEC,
including Eagle’s Quarterly Report on Form 10-Q for the quarter
ended June 30, 2022, which Eagle 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.
Wilson In-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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