FibroGen Reports UK Court Ruling

SAN FRANCISCO, April 20, 2020 (GLOBE NEWSWIRE) — FibroGen, Inc. (NASDAQ: FGEN) right now introduced that the UK’s Excessive Courtroom of Justice has held sure patents¹ referring to strategies of utilizing hypoxia-inducible issue prolyl hydroxylase inhibitors (HIF-PHIs) to be invalid. This choice doesn’t have an effect on the validity of those patents throughout the remainder of Europe.

Whereas FibroGen is disenchanted with the court docket’s choice, this UK ruling doesn’t have an effect on improvement or commercialization timelines for roxadustat, FibroGen’s HIF-PHI for therapy of anemia in power kidney illness, together with within the UK or elsewhere in Europe.

Roxadustat is a first-in-class small molecule HIF-PH inhibitor authorised in China for the therapy of anemia in power kidney illness (CKD) sufferers on dialysis and never on dialysis, and authorised in Japan for the therapy of anemia in CKD sufferers on dialysis, with a supplemental NDA for the non-dialysis indication submitted this previous January. The U.S. NDA for roxadustat for the therapy of anemia in CKD sufferers on dialysis and never on dialysis was accepted with a Prescription Drug Use Price (PDUFA) date of December 20, 2020. In Europe, the Advertising Authorization Utility submitting for roxadustat for the therapy of anemia in each dialysis- and non-dialysis-dependent sufferers with CKD is predicted within the second quarter of 2020.

About Roxadustat

Roxadustat is a first-in-class, orally administered small molecule HIF-PH inhibitor that promotes erythropoiesis by growing endogenous manufacturing of erythropoietin, enhancing iron regulation, and overcoming the unfavorable influence of irritation on hemoglobin synthesis and crimson blood cell manufacturing by downregulating hepcidin. Administration of roxadustat has been proven to induce coordinated erythropoiesis, growing crimson blood cell depend whereas sustaining plasma erythropoietin ranges inside or close to regular physiologic vary in a number of subpopulations of power kidney illness (CKD) sufferers, together with within the presence of irritation and with out a want for supplemental intravenous iron. Roxadustat is presently authorised in China for the therapy of anemia in CKD sufferers on dialysis and sufferers not on dialysis and authorised in Japan for the therapy of anemia in CKD sufferers on dialysis. The NDA submitting for roxadustat for the therapy of CKD anemia was accepted by the U.S. Meals and Drug Administration in February 2020 with a Prescription Drug Consumer Price Act date of December 20, 2020. Our accomplice Astellas expects the Advertising Authorization Utility submitting for roxadustat for the therapy of anemia in each dialysis- and non-dialysis-dependent sufferers with CKD to the European Medicines Company within the second quarter of 2020. Roxadustat is in Section three medical improvement within the U.S. and Europe and in Section 2/three improvement in China for anemia related to myelodysplastic syndromes (MDS), and in a Section 2 U.S. trial for therapy of chemotherapy-induced anemia.

Astellas and FibroGen are collaborating on the event and commercialization of roxadustat for the therapy of anemia in territories together with Japan, Europe, the Commonwealth of Impartial States, the Center East, and South Africa. AstraZeneca and FibroGen are collaborating on the event and commercialization of roxadustat for the therapy of anemia within the U.S., China, and different markets within the Americas and in Australia/New Zealand, in addition to Southeast Asia.

¹_{* UK designations of European patents EP(UK)1,463,823, EP(UK)2,298,301, EP(UK)1,633,333, EP(UK)2,322,153, and EP(UK)2,322,155}

About FibroGen

FibroGen, Inc., headquartered in San Francisco, California, with subsidiary places of work in Beijing and Shanghai, Folks’s Republic of China, is a biopharmaceutical firm discovering, growing, and commercializing a pipeline of first-in-class therapeutics. The corporate applies its pioneering experience in hypoxia-inducible issue (HIF) and connective tissue development issue (CTGF) biology, and medical improvement to advance progressive medicines for the therapy of anemia, fibrotic illness, and most cancers. Roxadustat, the corporate’s most superior product, an oral small molecule inhibitor of HIF prolyl hydroxylase exercise, is authorised by the Nationwide Medical Merchandise Administration in China for CKD sufferers on dialysis and never on dialysis and by the Ministry of Well being, Labour and Welfare in Japan for CKD sufferers on dialysis. The NDA submitting for roxadustat for the therapy of CKD anemia was accepted by the U.S. Meals and Drug Administration in February 2020. Our accomplice Astellas expects the Advertising Authorization Utility submitting for roxadustat for the therapy of anemia in each dialysis- and non-dialysis-dependent sufferers with CKD to the European Medicines Company within the second quarter of 2020. Roxadustat is in Section three medical improvement within the U.S. and Europe and in Section 2/three improvement in China for anemia related to myelodysplastic syndromes (MDS), and in a Section 2 U.S. trial for therapy of chemotherapy-induced anemia. Pamrevlumab, an anti-CTGF human monoclonal antibody, is in Section three medical improvement for the therapy of idiopathic pulmonary fibrosis (IPF) and domestically superior unresectable pancreatic most cancers, and is presently in a Section 2 trial for Duchenne muscular dystrophy (DMD). For extra data, please go to www.fibrogen.com.

Ahead-Wanting Statements

This launch comprises forward-looking statements relating to our technique, future plans and prospects, together with statements relating to the event and commercialization of the corporate’s product candidates, our medical applications and regulatory occasions, and people of our companions. These forward-looking statements embody, however should not restricted to, statements about our plans, aims, representations and contentions and should not historic information and usually are recognized by use of phrases similar to “might,” “will”, “ought to,” “on monitor,” “might,” “count on,” “plan,” “anticipate,” “consider,” “estimate,” “predict,” “potential,” “proceed” and comparable phrases, though some forward-looking statements are expressed otherwise. Our precise outcomes might differ materially from these indicated in these forward-looking statements on account of dangers and uncertainties associated to the continued progress and timing of our varied applications, together with the enrollment and outcomes from ongoing and potential future medical trials, and different issues which are described in our Annual Report on Type 10-Okay for the fiscal yr ended December 31, 2019 filed with the Securities and Change Fee (SEC), together with the chance elements set forth therein. Traders are cautioned to not place undue reliance on these forward-looking statements, which communicate solely as of the date of this launch, and we undertake no obligation to replace any forward-looking assertion on this press launch, besides as required by legislation.

Contact:

FibroGen, Inc.

Media Inquiries:

Sara Iacovino

1.703.474.4452

sara.iacovino@gcihealth.com

Traders:

Michael Tung, M.D.

Company Technique / Investor Relations

1.415.978.1433

mtung@fibrogen.com