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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): September 24, 2020

 

 

AKEBIA THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-36352   20-8756903

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

245 First Street

Cambridge, Massachusetts

  02142
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (617) 871-2098

N/A

(Former name or former address, if changed since last report)

 

 

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:

 

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

symbol(s)

 

Name of each exchange

on which registered

Common Stock, par value $0.00001 per share   AKBA   The Nasdaq Global Market

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  

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.

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