GlobeNewswire Inc | Oct 14, 2020 07:00AM EDT

October 14, 2020

Late-breaking abstracts explore cardiovascularoutcomes of patients with anemia in chronic kidney disease(CKD) treated with roxadustat, including associations with achieved hemoglobin levels and risk of Major Adverse Cardiovascular Events (MACE) and MACE+

New analyses evaluate efficacy of roxadustat across the continuum of patients with anemia in CKD both on dialysis and not on dialysis including different dialysis modalities, iron repletion status, and comorbidities.

Presentations address safety profile of roxadustat related to neoplasms, hypertension, and ophthalmological effects

Additional presentations explore increased risk of red blood cell transfusion at lower hemoglobin levels and impact of roxadustat on rates of hospitalization due to congestive heart failure

SAN FRANCISCO, Oct. 14, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (Nasdaq: FGEN) and its partners, AstraZeneca (LSE/STO/Nasdaq: AZN) 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.

Abstracts assessing the potential clinical profile for use of roxadustat for anemia treatment in CKD patients will include:

-- Red Blood Cell (RBC) Transfusion ReductionAbstracts on the potential of roxadustat to reduce the need for RBC transfusions across the continuum of patients with anemia in CKD include:

Lead Author Abstract # / Presentation Title Presentation Details Abstract PO0261: Risk of Transfusion in Patients Poster Session: with Non-Dialysis-Dependent CKD Increases with Anemia and IronDaniel Hemoglobin Levels <10 g/dL vs. ?10 g/dL: Pooled ManagementCoyne, MD Results from Roxadustat Phase 3 Studies October 22, FibroGen-sponsored On-Demand 10 AM-12 PM Abstract PO0268: Risk of Transfusion in Patients Poster Session:Robert with Dialysis-Dependent CKD Increases with Anemia and IronProvenzano, Hemoglobin Levels <10 g/dL vs. ?10 g/dL: Pooled ManagementMD Results from Roxadustat Phase 3 Studies October 22, FibroGen-sponsored On-Demand 10 AM-12 PM Abstract PO0264: Roxadustat Treatment Corrects Poster Session: Anemia to Hemoglobin (Hb) Values ?10g/dL in the Anemia and IronAnjay Majority of Patients with Non-Dialysis-Dependent ManagementRastogi, MD Chronic Kidney Disease (NDD-CKD) October 22, AstraZeneca-sponsored On-Demand 10 AM-12 PM

-- Congestive Heart Failure (CHF) HospitalizationAbstract comparing the rates of hospitalization due to CHF, a common and serious comorbidity in CKD patients, between roxadustat and comparators:

Lead Author Abstract # / Presentation Title Presentation Details Abstract SA-OR39: Pooled Analyses of the Poster Session: Phase 3 Roxadustat Studies: Congestive Heart Hypertension andRobert Failure Hospitalization Rates in Dialysis and Vascular Disease:Provenzano, Non-Dialysis Patients with Anemia Treated From the Lab toMD with Roxadustat vs. Comparators Trials FibroGen-sponsored October 24, Simulive 5-7 PM

-- Additional SafetyAbstracts addressing the safety profile of roxadustat include:

Lead Abstract # / Presentation Title Presentation DetailsAuthor Poster Session:Daniel Abstract TH-OR04: Roxadustat Is Not Associated Breakthroughs inCoyne, with An Increased Risk of Neoplasm in Patients Anemia and IronMD with CKD and Anemia Management FibroGen-sponsored October 22, Simulive 5-7PM Poster Session: CVD,Tak Mao Abstract PO2114: Roxadustat vs. Placebo or BP and KidneyDaniel Epoetin-alfa Has No Clinically Meaningful Effect Diseases: ExploringChan, MD on Blood Pressure in Patients with Anemia of CKD the Link FibroGen-sponsored October 22, On-Demand 10 AM-12 PMQuan Abstract PO0267: Ophthalmological Effects of Poster Session:Dong Roxadustat in the Treatment of Anemia in Anemia and IronNguyen, Dialysis-Dependent and Non?Dialysis-Dependent ManagementMD CKD Patients: Findings from Two Phase 3 Studies October 22, On-Demand Astellas-sponsored 10 AM-12 PM

-- Efficacy and SafetyAbstracts building on the known efficacy and safety profile of roxadustat for treatment of anemia across the continuum of CKD severity in patient subgroups with different comorbidities, dialysis status or dialysis modality in both NDD and DD CKD, include:

Lead Author Abstract # / Presentation Title Presentation DetailsIn Non-Dialysis-Dependent Patients (placebo-controlled studies: OLYMPUS, ANDES,ALPS) Abstract PO0260: Subgroup Analyses of Poster Session: Efficacy of Roxadustat for Treatment of Anemia and IronDaniel Coyne, Anemia in Patients with ManagementMD Non-Dialysis-Dependent CKD October 22, FibroGen-sponsored On-Demand 10 AM-12 PM Poster Session: Abstract PO1032: Efficacy and Safety of Diabetic KidneySimon Roger, Roxadustat in Patients with Disease: Clinical -MD Non?Dialysis-Dependent CKD, Anemia, and 2 Diabetes Mellitus October 22, FibroGen-sponsored On-Demand 10 AM-12 PM Poster Session: CVD, Abstract PO2111: Efficacy and Safety of BP and KidneySimon Roger, Roxadustat in Patients with Diseases: ExploringMD Non-Dialysis-Dependent CKD, Anemia, and the Link Heart Failure October 22, FibroGen-sponsored On-Demand 10 AM-12 PM Abstract TH-OR05: Roxadustat Treatment Poster Session: Results in Consistent Improvements in Breakthroughs inRoberto Hemoglobin (Hb) vs. Placebo: An Analysis of Anemia and IronPecoits-Filho, Three Multinational Randomized Clinical ManagementMD Trials in Patients with October 22, Simulive Non-Dialysis-Dependent CKD (NDD-CKD) 5-7 PM AstraZeneca-sponsoredIn Dialysis-Dependent Patients (epoetin alfa controlled studies: ROCKIES,SIERRAS, HIMALAYAS) Abstract SU-OR24: Efficacy and Safety of Poster Session: Roxadustat in Patients with Peritoneal DialysisTak Mao Daniel Dialysis-Dependent CKD and Anemia on and Vascular Access:Chan, MD Peritoneal Dialysis Research Abstracts FibroGen-sponsored October 25, Simulive 5-7 PM Poster Session: CVD, Abstract PO2112: Efficacy and Safety of BP and KidneyDaniel Coyne, Roxadustat in Patients with Diseases: ExploringMD Dialysis-Dependent CKD, Anemia, and Heart the Link Failure October 22, FibroGen-sponsored On-Demand 10 AM-12 PM Abstract PO0259: Subgroup Analyses of Poster Session: Efficacy of Roxadustat for Treatment of Anemia and IronRobert Anemia in Patients with Incident ManagementProvenzano, MD Dialysis-Dependent CKD October 22, FibroGen-sponsored On-Demand 10 AM-12 PM Poster Session: Abstract PO1031: Efficacy and Safety of Diabetic KidneyTak Mao Daniel Roxadustat in Patients with Disease: Clinical -Chan, MD Dialysis-Dependent CKD, Anemia, and 2 Diabetes Mellitus October 22, FibroGen-sponsored On-Demand 10 AM-12 PM Abstract FR-OR25: Efficacy and Safety of Poster Session: Roxadustat in Patients with Hemodialysis andRobert Dialysis-Dependent CKD and Anemia on Home Hemodialysis:Provenzano, MD Hemodialysis Research Abstract FibroGen-sponsored October 23, Simulive 5-7 PM

-- Efficacy and Safetyof Roxadustat Versus Darbepoetin AlfaAbstract on the primary results of a clinical trial on efficacy and safety of roxadustat in comparison to darbepoetin alfa in non-dialysis dependent patients (DOLOMITES):

Lead Abstract # / Presentation Title Presentation DetailsAuthor Abstract TH-OR02: Roxadustat for the Treatment Poster Session:Jonathan of Anemia in CKD Patients Not on Dialysis (NDD): Breakthroughs inBarratt, A Phase 3, Randomized, Open-label, Anemia and IronMD Active-controlled Study Management Astellas-sponsored October 22, Simulive 5-7 PM

-- Inflammation and IronAbstracts assessing roxadustat efficacy regardless of inflammation status as well as impact on iron homeostasis:

Lead Author Abstract # / Presentation Title Presentation DetailsIn Non-Dialysis-Dependent Patients (placebo-controlled studies: OLYMPUS, ANDES,ALPS) Poster Session: Abstract PO0262: Roxadustat Favorably Modifies Anemia and IronDaniel Iron Indices in Patients with ManagementCoyne, MD Non-Dialysis-Dependent CKD-related Anemia October 22, FibroGen-sponsored On-Demand 10 AM-12 PM Poster Session: Abstract PO0263: Roxadustat Increases Anemia and IronCarol Hemoglobin in Anemic Non-Dialysis-Dependent ManagementPollock, MD (NDD) CKD Patients Independent of Inflammation October 22, AstraZeneca-sponsored On-Demand 10 AM-12 PM Abstract PO0257: Hemoglobin (Hb) Correction Poster Session:Steven with Roxadustat is Associated with Improved Anemia and IronFishbane, Iron Homeostasis in Patients with ManagementMD Non-Dialysis-Dependent CKD (NDD-CKD) October 22, AstraZeneca-sponsored On-Demand 10 AM-12 PMIn Dialysis-Dependent Patients (epoetin alfa controlled studies: ROCKIES,SIERRAS, HIMALAYAS) Poster Session:Mohamed Abstract PO0265: Roxadustat Increases Anemia and IronEl-Shahawy, Hemoglobin in Anemic Dialysis-Dependent (DD) ManagementMD CKD Patients Independent of Inflammation October 22, AstraZeneca-sponsored On-Demand 10 AM-12 PM Abstract TH-OR06: Hemoglobin (Hb) Correction Poster Session: with Roxadustat Is Associated with Improved Breakthroughs inPablo Iron Homeostasis in Patients with Anemia and IronPergola, MD Dialysis-Dependent CKD (DD-CKD) Management AstraZeneca-sponsored October 22, Simulive 5-7 PM

About Anemia Associated with CKDChronic 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 patients opportunity for kidney transplant and can increase the risk of infection and/or complications such as heart failure and allergic reactions.

About RoxadustatRoxadustat 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 May21, 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 FibroGenFibroGen, 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). For more information, please visit www.fibrogen.com.

Forward-Looking StatementsThis release contains forward-looking statements regarding our strategy, future plans and prospects, including statements regarding the development and commercialization of the companys 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.

Contacts:FibroGen, Inc.

Investors:Michael Tung, MDCorporate Strategy / Investor Relations+1.415.978.1434mtung@fibrogen.com

Media InquiriesJennifer Harrington+1.610.574.9196jennifer.harrington@gcihealth.com