Item 8.01 Other Events.
On June 30, 2021, VYNE Therapeutics Inc. (the "Company") received a paragraph IV
certification notice (the "Notice") from Perrigo Israel Pharmaceuticals Ltd.
("Perrigo") advising that Perrigo 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,
9675,700, 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 "Challenged 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
Challenged Patents are invalid, unenforceable, and/or will not be infringed by
the commercial manufacture, use or sale of the generic product described in
Perrigo's ANDA. The Company is currently reviewing the Notice and intends to
vigorously defend and enforce its intellectual property rights protecting
AMZEEQ, as needed.
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