UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D)
OF THE SECURITIES EXCHANGE ACT OF 1934
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| Item 8.01. | Other Events. |
On September 24, 2020, 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. entered into a settlement and license agreement with Lupin Atlantis Holdings SA (“Lupin”) and Lupin Ltd. This settlement resolves patent litigation brought by Keryx and Panion in response to Lupin and Lupin Ltd.’s Paragraph IV certification notice letters regarding their Abbreviated New Drug Applications (“ANDAs”) 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 settlement, and consistent with Keryx’s prior ANDA settlements with Teva Pharmaceuticals USA, Inc. and its wholly owned, indirect subsidiary, Watson Laboratories, Inc., and with Par Pharmaceutical, Inc., Keryx and Panion will grant Lupin and Lupin Ltd. 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, Lupin, Lupin Ltd. and Dr. Hsu regarding Auryxia patents pending in the United States District Court for the District of Delaware. The settlement and license agreement is confidential and subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice.
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: September 25, 2020 | By: | /s/ John P. Butler | ||
| Name: | John P. Butler | |||
| Title: | President and Chief Executive Officer | |||