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UNITED STATES
SECURITIES AND
EXCHANGE COMMISSION
Washington, D.C.
20549
FORM 8-K
CURRENT REPORT
Pursuant to Section
13 or 15(d)
of the Securities
Exchange Act of 1934
Date of Report (Date of
earliest event reported): October 23, 2023
Eagle Pharmaceuticals, Inc.
(Exact name of registrant
as specified in its charter)
Delaware |
001-36306 |
20-8179278 |
(State
or other jurisdiction of |
(Commission File Number) |
(IRS Employer Identification No.) |
incorporation) |
|
|
50 Tice Boulevard, Suite 315
Woodcliff Lake, NJ |
|
07677 |
(Address of principal executive offices) |
|
(Zip Code) |
Registrant’s
telephone number, including area code: (201) 326-5300
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:
¨ Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities
registered pursuant to Section 12(b) of the Act:
Title of each class |
|
Trading
Symbol |
|
Name
of each exchange on which registered |
Common Stock (par value $0.001 per share) |
|
EGRX |
|
The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging
growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange
Act of 1934 (17 CFR §240.12b-2).
Emerging growth company ¨
If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards
provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 7.01 | Regulation FD Disclosure. |
On October 23, 2023,
Eagle Pharmaceuticals, Inc., or the Company, released a press release announcing that Centers for Medicare & Medicaid Services has
established a unique, product-specific billing code and granted transitional pass-through payment status for Barhemsys (amisulpride) injection.
A copy of the above-referenced
presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. The information
furnished pursuant to Item 7.01 of this current report, including Exhibit 99.1, shall not be deemed “filed” for purposes of
Section 18 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, or otherwise subject to the liabilities of that
section, and shall not be deemed incorporated by reference into any of the Company’s filings under the Securities Act of 1933,
as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in
such filing, except as shall be expressly set forth by specific reference in such filing. The furnishing of the information in this Current
Report on Form 8-K is not intended to, and does not, constitute a determination or admission by the Company that the information in this
Current Report on Form 8-K is material or complete, or that investors should consider this information before making an investment decision
with respect to any security of the Company.
Item 9.01 |
Financial Statements and Exhibits. |
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: October 23, 2023 |
EAGLE PHARMACEUTICALS, INC. |
|
|
|
|
|
By: |
/s/ Scott Tarriff |
|
|
|
Scott Tarriff |
|
|
|
Chief Executive Officer |
Exhibit 99.1
Eagle Pharmaceuticals
Granted Unique J-Code and Pass-Through Status for BARHEMSYS® from CMS
-- J-code is effective
January 1, 2024, and transitional pass-through status became effective October 1, 2023, facilitating patient access --
-- BARHEMSYS is
the first and only antiemetic approved by the FDA for rescue treatment of postoperative nausea and vomiting (“PONV”) despite
prophylaxis1 and is also approved for the treatment of PONV
in patients who have not received prophylaxis and for the prevention of PONV --
WOODCLIFF LAKE, N.J. — October
23, 2023 — Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced that Centers
for Medicare & Medicaid Services (“CMS”) has established a unique, product-specific billing code and granted transitional
pass-through payment status for Barhemsys (amisulpride) injection. The new Healthcare Common Procedure Coding System (“HCPCS”)
Level II code (“J-code”) is J-0184 “Injection, amisulpride, per 1 mg” and will be effective on January 1, 2024,
replacing the C-code (C-9153), which will be discontinued. Beginning October 1, 2023, Barhemsys became eligible for separate reimbursement
outside of the surgical bundled payment in both the ambulatory surgery center (“ASC”) and hospital outpatient department
(“HOPD”) care settings.
In addition to clinical complications
that may negatively affect patient outcomes, PONV can delay hospital discharge; result in re-admission after in-patient procedures; and
lead to day-case patients being admitted to the hospital, all of which can increase healthcare costs.2
By reducing these risks, Barhemsys offers the potential for significant economic savings to hospitals and ambulatory centers.
1
FDA labels for other recommended treatments do not include treatment after failed prophylaxis.
2
Chatterjee S, Rudra A, Sengupta S. Current concepts in the management of postoperative nausea
and vomiting. Anesthesiol Res Pract. 2011;2011:748031. doi: 10.1155/2011/748031. Epub 2011 Nov 3. PMID: 22110499; PMCID: PMC3216269.
“Receiving pass-through status,
as well as a J-code, is an ideal combination that will facilitate patient access to this important therapeutic,” stated Scott Tarriff,
President and Chief Executive Officer of Eagle. “Barhemsys is a significant product opportunity for Eagle, and we are pleased with
its growing adoption, giving us confidence in our ability to build on this momentum.”
“Post operative nausea and vomiting,
also known as PONV, is a common complication of surgery that occurs in approximately 30% of all surgical patients and 80% of high-risk
patients3. Barhemsys is the only drug with an FDA-approved
indication to treat patients who have failed PONV prophylaxis. With its potential to improve patient outcomes and enhance throughput,
Barhemsys addresses an important unmet medical need in a space that lacks proven and approved therapeutics,” said Valentin Curt,
MD, Senior Vice President, Clinical Drug Development and Interim Chief Medical Officer at Eagle Pharmaceuticals.
J-codes are reimbursement codes used
by commercial insurance plans, Medicare, Medicare Advantage, and other government payers for physician-administered drugs like Barhemsys
and are intended to simplify the claims submission and documentation process, facilitating access for patients.
Transitional pass-through payments provide
additional payment for new devices, drugs, and biologicals that meet eligibility criteria for a period of at least two years but not
more than three years.
The granting of pass-through status
helps streamline the reimbursement process and facilitates patient access to Barhemsys.
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 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, and the company is focused on developing medicines with the potential
to become part of the personalized medicine paradigm in cancer care. Additional information is available on Eagle’s website at
www.eagleus.com.
3
Sébastien Pierre, Rachel Whelan, Nausea and vomiting after surgery, Continuing Education
in Anaesthesia Critical Care & Pain, Volume 13, Issue 1, February 2013, Pages 28–32, https://doi.org/10.1093/bjaceaccp/mks046
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,” “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 Company’s ability to develop innovative medicines that address unmet medical needs; the potential of Barhemsys
to offer unique or meaningful therapeutic benefits to patients and potentially improving the treatment regimen for patients, and improving
patient outcomes; the maintenance of pass-through status and the application for a unique J-code with CMS and the benefits associated
therewith. All 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 impacts of the post-
COVID-19 environment and geopolitical factors such as the conflict in Ukraine; delay in or failure to obtain regulatory approval of the
Company's or its partners’ product candidates and successful compliance with FDA, European Medicines Agency and other governmental
regulations applicable to product approvals; changes in the regulatory environment; the uncertainties and timing of the regulatory approval
process; whether the Company can successfully market and commercialize its product candidates; the success of the Company's relationships
with its partners; 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; competition from other pharmaceutical
and biotechnology companies and the potential for competition from generic entrants into the market; unexpected safety or efficacy data
observed during clinical trials; clinical trial site activation or enrollment rates that are lower than expected; the risks inherent
in drug development and in conducting clinical trials; unanticipated factors in addition to the foregoing that may impact the Company’s
financial and business projections and guidance and 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, 2022, filed with the Securities and Exchange Commission (the “SEC”)
on March 23, 2023, the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, filed with the SEC on May
9, 2023, the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, filed with the SEC on August 8, 2023
and its other subsequent filings with the SEC. 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
Public Relations for Eagle Pharmaceuticals,
Inc.:
Faith Pomeroy-Ward
T: 817-807-8044
E: faith@eagleus.com
Important Safety Information for
BARHEMSYS® (amisulpride) Injection4
Contraindication
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%).
4
https://bynder.acaciapharma.com/m/5d7c2cd0d58865f7/original/Barhemsys-Prescribing-Information.pdf
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. |
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Eagle Pharmaceuticals (NASDAQ:EGRX)
過去 株価チャート
から 5 2024 まで 6 2024
Eagle Pharmaceuticals (NASDAQ:EGRX)
過去 株価チャート
から 6 2023 まで 6 2024