AKEBIA THERAPEUTICS, INC. (NASDAQ:AKBA) Files An 8-K Entry into a Material Definitive Agreement
Item 1.01. Entry into a Material Definitive Agreement.
As previously disclosed in its Annual Report on Form 10-K for the year ended December 31, 2019 (“2019 10-K”), Akebia Therapeutics, Inc. (“Akebia”) has entered into supply agreements with Esteve Química, S.A. and Patheon Inc. for the commercial manufacture of drug substance (“API”) and drug product, respectively, for its Phase 3 product candidate, vadadustat. Akebia also disclosed in its 2019 10-K that it intends to put additional supply arrangements in place for the commercial manufacture of vadadustat. Consistent with this disclosure, on April 2, 2020, Akebia entered into a Supply Agreement (“Supply Agreement”) with STA Pharmaceutical Hong Kong Limited, a subsidiary of Wuxi AppTec (“WuXi STA”). The Supply Agreement includes the terms and conditions under which WuXi STA will manufacture vadadustat API for commercial use.
to the Supply Agreement, Akebia is obligated to provide rolling forecasts to WuXi STA on a quarterly basis (the “Forecast”). The Forecast will reflect Akebia’s needs for API produced by WuXi STA over a certain number of months, represented as a quantity of API per calendar quarter. The parties have agreed to a volume-based pricing structure under the Supply Agreement.
The Supply Agreement has an initial term of four years, beginning April 2, 2020 and ending April 2, 2024. The Supply Agreement may be extended by mutual agreement of Akebia and Wuxi STA. The Supply Agreement allows Akebia to terminate the relationship on 180 days’ prior written notice for any reason.
The Supply Agreement includes customary indemnification, intellectual property protection, confidentiality, remedies, and warranty terms, as well as certain quality requirements.
The foregoing description of the Supply Agreement does not purport to be complete and is qualified in its entirety by reference to the Supply Agreement, a copy of which Akebia expects to file as an exhibit to its Quarterly Report on Form 10-Q for the quarter ending June 30, 2020.
About AKEBIA THERAPEUTICS, INC. (NASDAQ:AKBA)
Akebia Therapeutics, Inc. is a biopharmaceutical company. The Company is focused on the development of therapeutics based on hypoxia inducible factor (HIF) biology, and the commercialization of these products for patients with serious medical needs. The Company’s segment is the business of developing and commercializing proprietary therapeutics based on HIF biology. The Company is involved in developing its lead product candidate, vadadustat, as an oral therapy for the treatment of anemia in chronic kidney disease (CKD) subjects not on dialysis and in subjects on dialysis. Its other clinical candidate, AKB-6899, is designed as a small molecule HIF prolyl-hydroxylase (HIF-PH) inhibitor with therapeutic benefit in oncology and ophthalmology. The Company is engaged in conducting approximately two global Phase III studies for the treatment of anemia in non-dialysis dependent patients, and over two Phase III studies for the treatment of anemia in dialysis-dependent CKD patients.
