Current Report Filing (8-k)
February 21 2023 - 08:01AM
Edgar (US Regulatory)
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2023-02-20 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):
February 20, 2023
Intercept Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
|
Delaware |
|
001-35668 |
|
22-3868459 |
|
(State or other jurisdiction |
|
(Commission |
|
(IRS
Employer |
| of
incorporation) |
|
File
Number) |
|
Identification No.) |
305 Madison Avenue,
Morristown,
NJ
07960
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including area code: (646)
747-1000
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 |
ICPT |
Nasdaq Global Select Market |
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933
(§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange
Act of 1934 (§240.12b-2 of this chapter).
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 8.01 Other Events.
On February 20, 2023, Intercept Pharmaceuticals, Inc. (the
“Company”) and its subsidiary Intercept Pharma Europe Limited
(“IPEL”) (collectively, “Intercept”) entered into a settlement
agreement with Lupin Limited and Lupin Pharmaceuticals, Inc.
(collectively, “Lupin”) resolving the previously disclosed patent
litigation concerning the submission by Lupin of an Abbreviated New
Drug Application (“ANDA”) seeking approval to market a generic
version of Ocaliva® (obeticholic acid) 5 mg and 10 mg tablets prior
to expiration of the Company’s Orange Book listed patents.
Under the terms of the agreement, Intercept granted Lupin a
non-exclusive, non-sublicensable, non-transferable, royalty-free
license to commercialize its generic version of Ocaliva in the
United States commencing on February 28, 2034, or earlier under
certain circumstances. The parties will file the settlement
agreement with the Federal Trade Commission and the Department of
Justice pursuant to applicable law and will terminate their pending
litigation pursuant to a consent judgment that is subject to court
approval. Similar patent litigation previously disclosed by the
Company against other ANDA filers seeking approval to market
generic Ocaliva remains pending.
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.
| |
INTERCEPT
PHARMACEUTICALS, INC. |
| |
|
|
| |
By: |
/s/
Rocco Venezia |
| |
Name: |
Rocco Venezia |
| |
Title: |
Chief
Accounting Officer |
Date: February 21, 2023
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