Current Report Filing (8-k)
August 09 2021 - 4:34PM
Edgar (US Regulatory)
0001566044
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0001566044
2021-08-09
2021-08-09
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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) August 9, 2021
VYNE Therapeutics Inc.
(Exact name of registrant as specified
in its charter)
Delaware
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001-38356
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45-3757789
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(IRS Employer
Identification Number)
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520 U.S. Highway 22, Suite 204
Bridgewater, New Jersey 08807
(Address of principal executive offices,
including Zip Code)
(800) 775-7936
(Registrant’s telephone number,
including area code)
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:
¨
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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¨
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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¨
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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¨
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b)
of the Act:
Title of each class
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Trading
Symbol(s)
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Name of each exchange
on which registered
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Common Stock, $0.0001 par value
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VYNE
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The Nasdaq Stock Market LLC
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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 x
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.
As previously disclosed, on June 30, 2021, VYNE Therapeutics Inc.
(the “Company”) received a paragraph IV certification notice (the “Notice”) from Padagis Israel
Pharmaceuticals Ltd. (f/k/a Perrigo Israel Pharmaceuticals Ltd. (“Padagis”)) advising that Padagis has submitted to the
U.S. Food and Drug Administration (the “FDA”) an Abbreviated New Drug Application (“ANDA”) seeking approval
to manufacture and sell a generic version of the Company’s product AMZEEQ® (minocycline) topical foam, 4% in the United
States prior to the expiration of the Company’s U.S. patents Nos. 8,865,139, 8,945,516, 8,992,896, 9,675,700, 10,086,080,
10,137,200, 10,213,512, 10,265,404, 10,398,641, 10,517,882, 10,821,187, and 10,849,847 (the “Listed Patents”), which are
listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the “Orange
Book.” The Notice alleges that the Listed Patents are invalid, unenforceable, and/or will not be infringed by the commercial
manufacture, use or sale of the generic product described in Padagis’s ANDA.
On August 9, 2021, the Company initiated a patent infringement
suit against Padagis in the United States District Court for the District of Delaware arising from Padagis’s ANDA filing with
the FDA. The patent infringement suit asserts each of the Listed Patents. As a result, under applicable law, the FDA cannot grant
final approval to Padagis’s ANDA before December 30, 2023, or a court decision in Padagis’s favor.
The Company is seeking, among other relief, an order that the effective date of any FDA approval of Padagis’s ANDA be no earlier
than the expiration of the Listed Patents, the latest of which expires on September 8, 2037, and such further and other relief as
the court may deem appropriate.
The Company
intends to vigorously defend its intellectual property rights, including the Listed Patents.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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VYNE THERAPEUTICS INC.
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Date: August 9, 2021
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By:
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/s/ Mutya Harsch
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Mutya Harsch
Chief Legal Officer and General Counsel
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