Akebia Therapeutics, Inc 8-K, filed Jun 2, 2023
Akebia Therapeutics, Inc. (AKBA)
8-K
2023-06-02
For: 2023-05-30
View Original
Added on
April 11, 2026
About this 8-K
Akebia Therapeutics, Inc filed this 8-K on June 2, 2023, reporting on events of May 30, 2023.
Items reported
- Item 8.01: Other events
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
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CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): May 30, 2023
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Registrant’s telephone number, including area code: (617 ) 871-2098
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Item 8.01. Other Events.
On May 30, 2023, Keryx Biopharmaceuticals, Inc. (“Keryx”), a wholly owned subsidiary of Akebia Therapeutics, Inc. and Panion & BF Biotech, Inc. (“Panion”) entered into a settlement and license agreement (the “Agreement”) with Zydus Worldwide DMCC, Zydus Pharmaceuticals (USA) Inc. and Zydus Lifesciences Limited (collectively, “Zydus”). This settlement resolves patent litigation brought by Keryx and Panion in response to Zydus’ 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, Chemo Research S.L., and Mylan Pharmaceuticals Inc., Keryx and Panion will grant Zydus 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 and Zydus regarding Auryxia patents pending in the United States District Court for the District of Delaware. The Agreement is confidential and subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice.
Keryx and Panion have now entered into settlement and license agreements resolving all patent litigation proceedings brought by Keryx and Panion 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.
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.
| AKEBIA THERAPEUTICS, INC. | ||||||||
| Date: June 2, 2023 | By: | /s/ John P. Butler | ||||||
| Name: John P. Butler | ||||||||
| Title: President and Chief Executive Officer | ||||||||