0000827871
false
0000827871
2023-10-24
2023-10-24
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): October 24, 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 24, 2023, Eagle Pharmaceuticals,
Inc., or the Company, issued a press release announcing that the U.S. Patent and Trademark Office has granted the Company U.S. Patent
No. 11,793,813 entitled “Pemetrexed Formulations.” 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 Securities Exchange Act of 1934,
as amended, or subject to the liabilities of that section. The information shall not be deemed incorporated by reference into any other
filing with the Securities and Exchange Commission made by the Company, regardless of any general incorporation language in such filing.
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 24, 2023 |
EAGLE PHARMACEUTICALS, INC. |
|
By: |
/s/
Scott Tarriff |
|
|
Scott Tarriff |
|
|
Chief Executive Officer |
Exhibit 99.1
Eagle Pharmaceuticals
Granted Patent for PEMFEXY®
WOODCLIFF LAKE, N.J. — October
24, 2023 — Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced that the
U.S. Patent and Trademark Office has granted the Company U.S. Patent No. 11,793,813 (“the ‘813 patent”) entitled “Pemetrexed
Formulations.” Eagle has submitted the patent for listing in the U.S. Food and Drug Administration’s Orange Book.1
The ‘813 patent is directed to pemetrexed formulations, including the FDA-approved commercial formulation of PEMFEXY®.
The ‘813 patent will expire in
2036. This is the second patent to be listed in the Orange Book for PEMFEXY, and to date Eagle has not received any notice of a Paragraph
IV certification for an application referencing PEMFEXY.
“The issuance of this patent is
meaningful, as we continue to vigorously protect the commercial success of PEMFEXY and to add to the overall strength of our patent portfolio.
PEMFEXY maintains a unique J-Code from CMS and sales remain strong, with a 24% share in the commercial (non-340B) pemetrexed market leaving the third quarter of 2023,”
stated Scott Tarriff, President and Chief Executive Office of Eagle.
About PEMFEXY
PEMFEXY is a pemetrexed injection ready-to-dilute
formulation for locally advanced or metastatic nonsquamous non-small cell lung cancer in combination with cisplatin; locally advanced
or metastatic nonsquamous non-small cell lung cancer whose disease has not progressed after four cycles of platinum-based first-line
chemotherapy, as maintenance treatment; locally advanced or metastatic nonsquamous non-small cell lung cancer after prior chemotherapy
as a single agent; and malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative
surgery in combination with cisplatin.
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.
1
Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (fda.gov)
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: statements
regarding the Company’s expectations regarding the patent portfolio for PEMFEXY; the listing of patents for PEMFEXY in the
FDA’s Orange Book; the maintenance of a unique J-Code with CMS; and the sales of PEMFEXY and related market share. 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 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
v3.23.3
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
From Mar 2024 to Apr 2024
Eagle Pharmaceuticals (NASDAQ:EGRX)
Historical Stock Chart
From Apr 2023 to Apr 2024