Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the
“Company”) today announced the appointment of Debra M. Hussain as
Senior Vice President, Head of Commercial.
“We are very pleased with our acquisition of Acacia Pharma Group
Plc (“Acacia”) and its two commercial products, BARHEMSYS® and
BYFAVO®. As we commenced their integration, we continued to be
impressed with Acacia Pharma’s previous plans and positioning of
the products. It is our belief that the two products were
underinvested, both from a cost and manpower perspective.
Additionally, the products were launched into a very difficult
COVID environment, in which access to decision makers and
prescribers was limited. Acacia had approximately 70 employees
prior to the acquisition, of whom we have retained approximately
20. Most of those individuals are now members of our commercial
team. In reviewing the future plans, we were immensely impressed
with Debra’s vision, experience and leadership skills. Eagle is now
at its peak commercial strength with approximately 50 individuals.
We are very confident in Debra’s ability to lead the relaunches of
BARHEMSYS and BYFAVO and to prepare for the potential upcoming
launch of landiolol, if approved, and we welcome her to the Eagle
team. As stated previously, we believe peak annual U.S. sales of
the two products combined could potentially total $275 million.
Further, we believe that our strengthened infrastructure and
leadership provide Eagle with our best opportunity to achieve these
objectives,” stated Scott Tarriff, President and Chief Executive
Officer of Eagle Pharmaceuticals.
Debra brings nearly 25 years of pharmaceutical industry
experience leading commercial launches in the hospital and critical
care space. In 2021, Debra joined Acacia Pharma as Chief Commercial
Officer, overseeing its two commercial products, BARHEMSYS and
BYFAVO. Prior to that, Debra spent 22 years at Eli Lilly and
Company in positions of increasing responsibility, where she
created high-performing teams to support the U.S. launches of
multiple products. Debra has extensive experience in hospital-based
sales and marketing across cardiovascular, urology, diabetes,
neuroscience, osteoporosis, and critical care/anesthesia
specialties.
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 injection, PEMFEXY®,
RYANODEX®, BENDEKA®, BELRAPZO®, TREAKISYM (Japan), and its 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 concerning
the potential approval of the Company’s product candidates and the
potential launch of landiolol, if approved; the potential annual
sales of BARHEMSYS and BYFAVO; the ability of the Company’s and its
employees to execute on the Company’s strategy and capture the
value of hospital-based products; expectations with respect to
synergies; expectations regarding the Company’s future growth; 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 the Company’s recently completed
transaction with Acacia Pharma 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 the
Company’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 the Company’s business,
financial condition and results of operations; whether the Company
will incur unforeseen expenses or liabilities or other market
factors; whether the Company will successfully implement its
development plan for its product candidates; delay in or failure to
obtain regulatory approval of the Company’s or its partners’
product candidates; whether the Company can successfully market and
commercialize its products or product candidates; the success of
the Company’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 the Company’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 the Company’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 the Company’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 the Company’s 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 and its other
subsequent filings with the SEC, including the Company’s Quarterly
Report on Form 10-Q for the quarter ended March 31, 2022, which the
Company filed with the SEC on May 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
BARHEMSYS® (amisulpride)
Injection
Contraindication1
BARHEMSYS is contraindicated in patients with known
hypersensitivity to amisulpride.
QT Prolongation
BARHEMSYS causes dose- and concentration-dependent prolongation
of the QT interval. The recommended dosage is 5 mg or 10 mg as a
single intravenous (IV) dose infused over 1 to 2 minutes.
Avoid BARHEMSYS in patients with congenital long QT syndrome and
in patients taking droperidol.
Electrocardiogram (ECG) monitoring is recommended in patients
with pre-existing arrhythmias/cardiac conduction disorders,
electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia),
congestive heart failure, and in patients taking other medicinal
products (e.g., ondansetron) or with other medical conditions known
to prolong the QT interval.
Adverse Reactions
Common adverse reactions reported in ≥ 2% of adult patients who
received BARHEMSYS 5 mg (n=748) and at a higher rate than placebo
(n=741) in clinical trials for the prevention of PONV were: chills
(4% vs. 3%), hypokalemia (4% vs. 2%), procedural hypotension (3%
vs. 2%), and abdominal distention (2% vs. 1%).
Serum prolactin concentrations were measured in one prophylaxis
study where 5% (9/176) of BARHEMSYS-treated patients had increased
blood prolactin reported as an adverse reaction compared with 1%
(1/166) of placebo-treated patients.
The most common adverse reaction, reported in ≥ 2% of adult
patients who received BARHEMSYS 10 mg (n=418) and at a higher rate
than placebo (n=416), in clinical trials for the treatment of PONV
was infusion site pain (6% vs. 4%).
Use in Specific Populations
Lactation
Amisulpride is present in human milk. There are no reports of
adverse effects on the breastfed child and no information on the
effects of amisulpride on milk production.
BARHEMSYS may result in an increase in serum prolactin levels,
which may lead to a reversible increase in maternal milk
production. In a clinical trial, serum prolactin concentrations in
females (n=112) increased from a mean of 10 ng/mL at baseline to 32
ng/mL after BARHEMSYS treatment and from 10 ng/mL to 19 ng/mL in
males (n=61). No clinical consequences due to elevated prolactin
levels were reported.
To minimize exposure to a breastfed infant, lactating women may
consider interrupting breastfeeding and pumping and discarding
breast milk for 48 hours after receiving a dose of BARHEMSYS.
Pediatric Use
Safety and effectiveness in pediatric patients have not been
established.
Geriatric Use
No overall differences in safety or effectiveness were observed
between these patients and younger patients, and other reported
clinical experience has not identified differences in responses
between the elderly and younger patients, but greater sensitivity
of some older individuals cannot be ruled out.
Renal Impairment
Avoid BARHEMSYS in patients with severe renal impairment
(estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73
m2). The pharmacokinetics of amisulpride in patients with severe
renal impairment have not been adequately studied in clinical
trials. Amisulpride is known to be substantially excreted by the
kidneys, and patients with severe renal impairment may have
increased systemic exposure and an increased risk of adverse
reactions.
No dosage adjustment is necessary in patients with mild to
moderate renal impairment
(eGFR ≥ 30 mL/min/1.73 m2).
Drug Interactions
- BARHEMSYS causes dose- and concentration-dependent QT
prolongation. To avoid potential additive effects, avoid use of
BARHEMSYS in patients taking droperidol.
- ECG monitoring is recommended in patients taking other drugs
known to prolong the QT interval (e.g., ondansetron).
- Reciprocal antagonism of effects occurs between dopamine
agonists (e.g., levodopa) and BARHEMSYS. Avoid using levodopa with
BARHEMSYS.
Important Safety Information for
BYFAVO™ (remimazolam)
Injection
Indications2
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 (e.g., 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.
1
https://bynder.acaciapharma.com/m/5d7c2cd0d58865f7/original/Barhemsys-Prescribing-Information.pdf2
https://bynder.acaciapharma.com/m/403e8c343b2922de/original/Byfavo-PI.pdf
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