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    4503   JP3942400007


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Astellas Pharma : FibroGen to Present New Efficacy and Safety Analyses from Roxadustat Global Phase 3 Program at American Society of Nephrology Kidney Week 2020 Reimagined

10/15/2020 | 08:23am EDT

SAN FRANCISCO - FibroGen, Inc. and its partners, AstraZeneca and Astellas Pharma Inc. (TSE: 4503), will present new analyses from the global Phase 3 program at the upcoming American Society of Nephrology (ASN) Kidney Week 2020 Reimagined, assessing the potential of roxadustat, a first-in-class orally-administered hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, to revolutionize the treatment of anemia in patients with chronic kidney disease (CKD).

The virtual congress will take place October 22-25, 2020. FibroGen and its partners will present 42 abstracts, including 2 late-breaker poster presentations, and 10 which have been accepted for oral presentation.

Twenty-eight presentations on roxadustat for the treatment of anemia associated with CKD will further demonstrate the depth and breadth of the roxadustat global Phase 3 development program and build on the known clinical profile of roxadustat in treating a broad spectrum of CKD patients. Another 12 presentations on CKD anemia epidemiology and disease state outline the burden of anemia on CKD patients and their unmet medical need for innovative therapies. In addition, two late-breaking poster presentations will explore associations between cardiovascular safety and hemoglobin levels achieved with roxadustat in both non-dialysis-dependent (NDD) and dialysis-dependent (DD) CKD patients.

'Our roxadustat clinical data at ASN Kidney Week 2020 Reimagined demonstrate consistent efficacy and positive safety results across the continuum of chronic kidney disease patients with anemia, adding to the established body of evidence highlighting roxadustat as a potential foundational treatment for this condition affecting millions of patients,' said Enrique Conterno, Chief Executive Officer, FibroGen. 'We thank the investigators, study site staff, and patients who participated in the global roxadustat development program.'

About Anemia Associated with CKD

Chronic kidney disease (CKD) is generally a progressive disease characterized by gradual loss of kidney function that may eventually lead to kidney failure or end stage renal disease, requiring dialysis or kidney transplant. CKD is estimated to occur in approximately 10-12% of adults worldwide and is predicted to become the fifth most common cause of premature death globally by 2040.

Anemia, a serious medical condition in which patients have insufficient red blood cells and low levels of hemoglobin, is a common early complication of CKD, affecting approximately 20% of CKD patients. Anemia in CKD is associated with an increased risk of hospitalization, cardiovascular complications, and death, and can also cause significant fatigue, cognitive dysfunction and reduced quality of life. Blood transfusions are used for treating severe anemia, however, they may reduce a patient's opportunity for kidney transplant and can increase the risk of infection and/or complications such as heart failure and allergic reactions.

About Roxadustat

Roxadustat is a first-in-class, oral small molecule HIF-PH inhibitor that promotes erythropoiesis through increased endogenous production of erythropoietin; improved iron absorption, transport, and mobilization and downregulation of hepcidin, which helps to overcome the negative impact of inflammation on hemoglobin synthesis and red blood cell production. Roxadustat is approved in China for the treatment of anemia in adult patients with CKD, both on dialysis and not on dialysis. In Japan, roxadustat is approved for the treatment of anemia in CKD patients on dialysis, and a supplemental NDA for the treatment of anemia in CKD patients not on dialysis is under regulatory review. The roxadustat NDA for the treatment of anemia in CKD in patients both on dialysis and not on dialysis is under review by the U.S. Food and Drug Administration with a Prescription Drug User Fee Act date of December 20, 2020. The Marketing Authorization Application for roxadustat for the treatment of anemia in CKD in patients both on dialysis and not on dialysis was filed by our partner Astellas and accepted by the European Medicines Agency for review on May 21, 2020. Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and chemotherapy-induced anemia (CIA).

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. At ASN Kidney Week 2020 Reimagined, roxadustat data will be sponsored and presented by Astellas, AstraZeneca, and FibroGen.

About FibroGen

FibroGen, Inc. is a biopharmaceutical company committed to 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 to advance innovative medicines for the treatment of unmet needs. The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD). Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA). Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and coronavirus (COVID-19).

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, the potential safety and efficacy profile of our 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 and our Quarterly Report on Form 10-Q for quarter ended June 30, 2020 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.


Michael Tung

Tel: +1.415.978.1434

Email: mtung@fibrogen.com

(C) 2020 Electronic News Publishing, source ENP Newswire

Stocks mentioned in the article
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ASTELLAS PHARMA INC. 0.18% 1943 End-of-day quote.21.89%
FIBROGEN, INC. 2.55% 26.96 Delayed Quote.-29.12%
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