false
0000827871
0000827871
2023-12-06
2023-12-06
iso4217:USD
xbrli:shares
iso4217:USD
xbrli:shares
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): December 6, 2023
Eagle Pharmaceuticals, Inc.
(Exact Name of Registrant
as Specified in its Charter)
Delaware |
001-36306 |
20-8179278 |
(State
or Other Jurisdiction
of Incorporation) |
(Commission
File Number) |
(IRS Employer Identification No.) |
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 obligation 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(s) |
|
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 December 6, 2023, Eagle Pharmaceuticals,
Inc., or the Company, issued a press release announcing that its abstract, a post-hoc analysis of two multicenter, placebo-controlled,
Phase III studies evaluating amisulpride (a selective dopamine D2/D3 antagonist) as an antiemetic in patients with established postoperative
nausea and vomiting, has been selected for a poster presentation at the 77th PGA (PostGraduate Assembly in Anesthesiology), being held
December 8-11, 2023, in New York City. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and
is incorporated herein by reference.
The
information furnished under this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18
of 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 Securities Act, 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..
Item 9.01 Financial Statements and Exhibits.
(d) 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.
Date: December 6, 2023 |
|
|
|
|
|
|
EAGLE PHARMACEUTICALS, INC.
|
|
By: |
/s/ Brian Cahill |
|
|
Brian Cahill |
|
|
Chief Financial Officer |
Exhibit 99.1
Eagle Pharmaceuticals
to Present Abstract on Post-hoc Analysis of Amisulpride at the 77th PGA (PostGraduate Assembly in Anesthesiology) in New York City
-- BARHEMSYS®
(amisulpride) Injection is the first and only antiemetic approved by the U.S. Food and Drug Administration (“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
--
-- In patients who
experience PONV, the incidence of nausea is substantially greater than the incidence of vomiting2,3
--
-- This post-hoc
analysis of pivotal trials demonstrates that Barhemsys provides statistically significant (p=0.006) nausea relief in patients
with established PONV --
-- A single 10 mg
dose of intravenous amisulpride significantly reduced patients’ nausea across multiple measures, including significant nausea,
use of rescue medication, and evolution of nausea over time, and the adverse event profile was comparable between the placebo and 10
mg amisulpride arms –
-- Unique J-code
for Barhemsys (J-0184) from CMS effective on January 1, 2024 --
1
FDA labels for other recommended treatments do not include treatment after failed prophylaxis.
2
Habib AS, et al. Anesthesiology. 2019; 130(2):203-212.
3
Habib AS, et al. Curr Med Res Opin. 2006; 22(6):1039-1099.
WOODCLIFF LAKE, N.J. — December 6, 2023 — Eagle Pharmaceuticals,
Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced that its abstract, a post-hoc analysis of two multicenter,
placebo-controlled, Phase III studies evaluating amisulpride (a selective dopamine D2/D3 antagonist) as an antiemetic in patients with
established postoperative nausea and vomiting, has been selected for a poster presentation at the 77th PGA (PostGraduate Assembly in Anesthesiology),
being held December 8-11, 2023, in New York City. The conference is sponsored by the New York State Society of Anesthesiologists and is
a global platform for presenting anesthesia’s latest science and technologies.
“PONV contributes to prolonged post-anesthesia care unit and
hospital stays and is distressing to patients and healthcare providers,” stated Mike Greenberg, MD, Vice President of Medical Affairs
at Eagle Pharmaceuticals. “In patients who experience PONV, nausea occurs much more frequently than vomiting. This analysis details
pooled data on nausea-related outcomes from two Phase III trials. We are pleased to share that the proportion of patients with PONV experiencing
substantial nausea in these studies was statistically significantly lower in the amisulpride 10 mg group than in the placebo group. We
believe Barhemsys presents an opportunity for a much-needed therapeutic option for these patients,” concluded Dr. Greenberg.
Details of the poster presentation are as follows:
Abstract Title: Amisulpride Provides Significant Nausea
Reduction in Patients with Established Postoperative Nausea and Vomiting: Pooled Results from Two Phase III Trials
Date: |
December 10, 2023 |
Time: |
3:30pm ET |
Location: |
Room 4, Monitor 7 |
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.
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
potential benefits of Barhemsys, including its potential to present a therapeutic option for patients with PONV; the ability of Barhemsys
and other products and product candidates to address underserved therapeutic areas across multiple disease states; the Company’s
ability to develop medicines with the potential to become part of the personalized medicine paradigm in cancer care; and the anticipated
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 timing and ability of the Company’s reporting of financial and business results, the Company’s
ability to recruit and hire a new Chief Executive Officer, the impacts of the post- COVID-19 environment and geopolitical factors such
as the conflicts between Russia and Ukraine and Gaza and Israel; 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; risks inherent in estimates or judgments relating to the Company’s critical
accounting policies, or any of the Company’s estimates or projections, which may prove to be inaccurate; the Company’s ability
to maintain its listing on the Nasdaq Stock Market; 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 Reports on Form 10-Q for the quarter ended March 31, 2023, filed with the SEC on May
9, 2023, and 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.
Indication and Important Safety Information for Barhemsys® (amisulpride)
Injection4
Indication
Barhemsys is a selective dopamine-2 (D2) and dopamine-3
(D3) receptor antagonist indicated in adults for prevention of PONV either alone or in combination with an antiemetic of a
different class and treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or
have not received prophylaxis.
Important Safety Information
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 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
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
Pregnancy
Available data with amisulpride use in pregnant women are insufficient
to establish a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
4
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209510s005lbl.pdf
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.
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. |
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
v3.23.3
Cover
|
Dec. 06, 2023 |
Cover [Abstract] |
|
Document Type |
8-K
|
Amendment Flag |
false
|
Document Period End Date |
Dec. 06, 2023
|
Entity File Number |
001-36306
|
Entity Registrant Name |
Eagle Pharmaceuticals, Inc.
|
Entity Central Index Key |
0000827871
|
Entity Tax Identification Number |
20-8179278
|
Entity Incorporation, State or Country Code |
DE
|
Entity Address, Address Line One |
50 Tice Boulevard
|
Entity Address, Address Line Two |
Suite 315
|
Entity Address, City or Town |
Woodcliff Lake
|
Entity Address, State or Province |
NJ
|
Entity Address, Postal Zip Code |
07677
|
City Area Code |
201
|
Local Phone Number |
326-5300
|
Written Communications |
false
|
Soliciting Material |
false
|
Pre-commencement Tender Offer |
false
|
Pre-commencement Issuer Tender Offer |
false
|
Title of 12(b) Security |
Common Stock, par value $0.001 per share
|
Trading Symbol |
EGRX
|
Security Exchange Name |
NASDAQ
|
Entity Emerging Growth Company |
false
|
X |
- DefinitionBoolean flag that is true when the XBRL content amends previously-filed or accepted submission.
+ References
+ Details
Name: |
dei_AmendmentFlag |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionFor the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.
+ References
+ Details
Name: |
dei_DocumentPeriodEndDate |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:dateItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.
+ References
+ Details
Name: |
dei_DocumentType |
Namespace Prefix: |
dei_ |
Data Type: |
dei:submissionTypeItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionAddress Line 1 such as Attn, Building Name, Street Name
+ References
+ Details
Name: |
dei_EntityAddressAddressLine1 |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionAddress Line 2 such as Street or Suite number
+ References
+ Details
Name: |
dei_EntityAddressAddressLine2 |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- Definition
+ References
+ Details
Name: |
dei_EntityAddressCityOrTown |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionCode for the postal or zip code
+ References
+ Details
Name: |
dei_EntityAddressPostalZipCode |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionName of the state or province.
+ References
+ Details
Name: |
dei_EntityAddressStateOrProvince |
Namespace Prefix: |
dei_ |
Data Type: |
dei:stateOrProvinceItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionA unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityCentralIndexKey |
Namespace Prefix: |
dei_ |
Data Type: |
dei:centralIndexKeyItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionIndicate if registrant meets the emerging growth company criteria.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityEmergingGrowthCompany |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionCommission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.
+ References
+ Details
Name: |
dei_EntityFileNumber |
Namespace Prefix: |
dei_ |
Data Type: |
dei:fileNumberItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTwo-character EDGAR code representing the state or country of incorporation.
+ References
+ Details
Name: |
dei_EntityIncorporationStateCountryCode |
Namespace Prefix: |
dei_ |
Data Type: |
dei:edgarStateCountryItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityRegistrantName |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityTaxIdentificationNumber |
Namespace Prefix: |
dei_ |
Data Type: |
dei:employerIdItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionLocal phone number for entity.
+ References
+ Details
Name: |
dei_LocalPhoneNumber |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 13e -Subsection 4c
+ Details
Name: |
dei_PreCommencementIssuerTenderOffer |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 14d -Subsection 2b
+ Details
Name: |
dei_PreCommencementTenderOffer |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTitle of a 12(b) registered security.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b
+ Details
Name: |
dei_Security12bTitle |
Namespace Prefix: |
dei_ |
Data Type: |
dei:securityTitleItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionName of the Exchange on which a security is registered.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection d1-1
+ Details
Name: |
dei_SecurityExchangeName |
Namespace Prefix: |
dei_ |
Data Type: |
dei:edgarExchangeCodeItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Section 14a -Number 240 -Subsection 12
+ Details
Name: |
dei_SolicitingMaterial |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTrading symbol of an instrument as listed on an exchange.
+ References
+ Details
Name: |
dei_TradingSymbol |
Namespace Prefix: |
dei_ |
Data Type: |
dei:tradingSymbolItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Securities Act -Number 230 -Section 425
+ Details
Name: |
dei_WrittenCommunications |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
Eagle Pharmaceuticals (NASDAQ:EGRX)
Historical Stock Chart
Von Apr 2024 bis Mai 2024
Eagle Pharmaceuticals (NASDAQ:EGRX)
Historical Stock Chart
Von Mai 2023 bis Mai 2024