SECURITIES AND EXCHANGE COMMISSION
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|Item 8.01|| |
On September 22, 2021, Keryx Biopharmaceuticals, Inc. (“Keryx”), a wholly owned subsidiary of Akebia Therapeutics, Inc., and its licensors, Panion & BF Biotech, Inc. (“Panion”) and Chen Hsing Hsu, M.D. (“Dr. Hsu”) entered into a settlement and license agreement (the “Agreement”) with Mylan Pharmaceuticals Inc. (“Mylan”). This settlement resolves patent litigation brought by Keryx, Panion and Dr. Hsu in response to Mylan’s Paragraph IV certification notice letter regarding their Abbreviated New Drug Application (“ANDA”) seeking approval to market a generic version of Auryxia® (ferric citrate) tablets prior to the expiration of the applicable patents. Pursuant to the terms of the Agreement and, consistent with Keryx’s prior ANDA settlements with Teva Pharmaceuticals USA, Inc., Watson Laboratories, Inc., Par Pharmaceutical, Inc., Lupin Atlantis Holdings SA, and Chemo Research S.L., Keryx, Panion and Dr. Hsu will grant Mylan a license to market a generic version of Auryxia® in the United States beginning on March 20, 2025 (subject to U.S. Food and Drug Administration approval), or earlier under certain circumstances customary for settlement agreements of this nature. Additionally, in accordance with the Agreement, the parties will terminate all ongoing litigation among Keryx, Panion, Dr. Hsu and Mylan regarding Auryxia patents pending in the United States District Court for the District of Delaware and the North District Court of West Virginia. The Agreement is confidential and subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice.
Keryx, Panion and, as applicable, Dr. Hsu have now entered into settlement and license agreements resolving all patent litigation proceedings brought by Keryx, Panion and, as applicable, Dr. Hsu, in response to ANDAs filed by third parties seeking approval to market generic versions of Auryxia® (ferric citrate) tablets prior to the expiration of the applicable patents.
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.
|AKEBIA THERAPEUTICS, INC.|
|Date: September 28, 2021||By:|
Name: John P. Butler
Title: President and Chief Executive Officer