SAN FRANCISCO, April 20, 2020 (GLOBE NEWSWIRE) — FibroGen, Inc. (NASDAQ: FGEN) today announced that the United Kingdom’s High Court of Justice has held certain patents1 relating to methods of using hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) to be invalid. This decision does not affect the validity of these patents across the rest of Europe.
While FibroGen is disappointed with the court’s decision, this UK ruling does not affect development or commercialization timelines for roxadustat, FibroGen’s HIF-PHI for treatment of anemia in chronic kidney disease, including in the UK or elsewhere in Europe.Roxadustat is a first-in-class small molecule HIF-PH inhibitor approved in China for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis, and approved in Japan for the treatment of anemia in CKD patients on dialysis, with a supplemental NDA for the non-dialysis indication submitted this past January. The U.S. NDA for roxadustat for the treatment of anemia in CKD patients on dialysis and not on dialysis was accepted with a Prescription Drug Use Fee (PDUFA) date of December 20, 2020. In Europe, the Marketing Authorization Application filing for roxadustat for the treatment of anemia in both dialysis- and non-dialysis-dependent patients with CKD is expected in the second quarter of 2020.About RoxadustatRoxadustat is a first-in-class, orally administered small molecule HIF-PH inhibitor that promotes erythropoiesis through increasing endogenous production of erythropoietin, improving iron regulation, and overcoming the negative impact of inflammation on hemoglobin synthesis and red blood cell production by downregulating hepcidin. Administration of roxadustat has been shown to induce coordinated erythropoiesis, increasing red blood cell count while maintaining plasma erythropoietin levels within or near normal physiologic range in multiple subpopulations of chronic kidney disease (CKD) patients, including in the presence of inflammation and without a need for supplemental intravenous iron. Roxadustat is currently approved in China for the treatment of anemia in CKD patients on dialysis and patients not on dialysis and approved in Japan for the treatment of anemia in CKD patients on dialysis. The NDA filing for roxadustat for the treatment of CKD anemia was accepted by the U.S. Food and Drug Administration in February 2020 with a Prescription Drug User Fee Act date of December 20, 2020. Our partner Astellas expects the Marketing Authorization Application filing for roxadustat for the treatment of anemia in both dialysis- and non-dialysis-dependent patients with CKD to the European Medicines Agency in the second quarter of 2020. Roxadustat is in Phase 3 clinical development in the U.S. and Europe and in Phase 2/3 development in China for anemia associated with myelodysplastic syndromes (MDS), and in a Phase 2 U.S. trial for treatment of chemotherapy-induced anemia.Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in territories including Japan, Europe, the Commonwealth of Independent States, the Middle East, and South Africa. AstraZeneca and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in the U.S., China, and other markets in the Americas and in Australia/New Zealand, as well as 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)2,322,155About FibroGen
FibroGen, Inc., headquartered in San Francisco, California, with subsidiary offices in Beijing and Shanghai, People’s Republic of China, is a biopharmaceutical company discovering, developing, and commercializing a pipeline of first-in-class therapeutics. The company applies its pioneering expertise in hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology, and clinical development to advance innovative medicines for the treatment of anemia, fibrotic disease, and cancer. Roxadustat, the company’s most advanced product, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, is approved by the National Medical Products Administration in China for CKD patients on dialysis and not on dialysis and by the Ministry of Health, Labour and Welfare in Japan for CKD patients on dialysis. The NDA filing for roxadustat for the treatment of CKD anemia was accepted by the U.S. Food and Drug Administration in February 2020. Our partner Astellas expects the Marketing Authorization Application filing for roxadustat for the treatment of anemia in both dialysis- and non-dialysis-dependent patients with CKD to the European Medicines Agency in the second quarter of 2020. Roxadustat is in Phase 3 clinical development in the U.S. and Europe and in Phase 2/3 development in China for anemia associated with myelodysplastic syndromes (MDS), and in a Phase 2 U.S. trial for treatment of chemotherapy-induced anemia. Pamrevlumab, an anti-CTGF human monoclonal antibody, is in Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and locally advanced unresectable pancreatic cancer, and is currently in a Phase 2 trial for Duchenne muscular dystrophy (DMD). For more information, please visit www.fibrogen.com.Forward-Looking Statements
This release contains forward-looking statements regarding our strategy, future plans and prospects, including statements regarding the development and commercialization of the company’s product candidates, our clinical programs and regulatory events, and those of our partners. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as “may,” “will”, “should,” “on track,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. Our actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of our various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019 filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement in this press release, except as required by law.Contact:
FibroGen, Inc.Media Inquiries:
Sara Iacovino
1.703.474.4452
[email protected]Investors:
Michael Tung, M.D.
Corporate Strategy / Investor Relations
1.415.978.1433
[email protected]
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