AKEBIA THERAPEUTICS, INC. (NASDAQ:AKBA) Files An 8-K Other Events

ME Staff 8-k
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AKEBIA THERAPEUTICS, INC. (NASDAQ:AKBA) Files An 8-K Other Events
Item 8.01.

Favorable Ruling on Invalidity Proceedings Against FibroGen, Inc. in the United Kingdom

As previously disclosed, on December 13, 2018 Akebia Therapeutics, Inc. (“Akebia” or the “Company”) and Akebia’s collaboration partner for its Phase 3 product candidate, vadadustat, Otsuka Pharmaceutical Co. Ltd. (“Otsuka”), filed Particulars of Claim in the Patents Court of the United Kingdom (the “UK”) to challenge the validity of FibroGen, Inc.’s (“Fibrogen’s”) six hypoxia inducible factor-related patents in the UK: European Patent (UK) No. 1463823 (the “’823 EP Patent (UK)”), European Patent (UK) No. 1633333 (the “’333 EP Patent (UK)”), European Patent (UK) No. 2322153 (the “’153 EP Patent (UK)”), European Patent (UK) No. 2322155 (the “’155 EP Patent (UK)”), European Patent (UK) No. 2289531 (the “’531 EP Patent (UK)”), and European Patent (UK) No. 2298301 (the “’301 EP Patent (UK)”). Also as previously disclosed, in September 2019, Akebia and Otsuka filed an Amended Particulars of Claim to include FibroGen’s European Patent No. 1487472 (the “’472 EP Patent (UK)”), and on February 28, 2020, the parties agreed to dismiss the ’472 EP Patent (UK) from the lawsuit.

A trial was conducted on March 2-19, 2020. On April 20, 2020, the Patents Court of the United Kingdom issued a judgment in favor of Akebia and Otsuka, which invalidated all of the claims at issue in each of the ’823 EP Patent (UK), the ’333 EP Patent (UK), the ’153 EP Patent (UK), the ’155 EP Patent (UK) and the ’301 EP Patent (UK). The ’531 EP Patent (UK) was amended to a single claim to recite one specific compound; this claim was held to be valid but not infringed by vadadustat.


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.