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Phase III OLYMPUS and ROCKIES Trials for roxadustat Met Their Primary Endpoints in Chronic Kidney Disease Patients With Anemia

December 20, 2018

WILMINGTON, Del.--(BUSINESS WIRE)--Dec 20, 2018--AstraZeneca today announced that the Phase III OLYMPUS and ROCKIES trials for roxadustat each met their primary efficacy endpoint for the treatment of patients with anemia in chronic kidney disease (CKD) that are either non-dialysis-dependent (NDD) or dialysis-dependent (DD), respectively. Roxadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) and a potential first-in-class new medicine to treat anemia in CKD being jointly developed and commercialized by AstraZeneca and FibroGen, Inc.

OLYMPUS is a Phase III, randomized, double-blinded, placebo-controlled trial designed to evaluate the efficacy and safety of roxadustat vs. placebo for the treatment of patients with anemia in CKD stages 3, 4 and 5 whose disease progression is moderate to severe and who are non-dialysis-dependent (NDD). The trial met its primary efficacy endpoint by demonstrating a statistically-significant and clinically-meaningful improvement in mean change from baseline in hemoglobin (Hb) levels averaged over weeks 28 to 52 vs. placebo. The trial evaluated 2,781 patients in 26 countries.

ROCKIES is a Phase III, randomized, open-label, active-controlled trial designed to assess the efficacy and safety of roxadustat vs. an erythropoietin-stimulating agent (ESA), epoetin alfa, for the treatment of patients with anemia in CKD who are dialysis-dependent (DD). The trial met its primary efficacy endpoint by demonstrating a statistically-significant improvement in mean change from baseline in Hb levels averaged over weeks 28 to 52 vs. epoetin alfa. The trial evaluated 2,133 patients in 18 countries.

The global Phase III program consists of more than 9,000 patients in trials conducted by AstraZeneca, FibroGen and Astellas. In September 2018, Astellas announced high-level results from the Phase III ALPS trial. FibroGen and Astellas anticipate reporting high level results from their remaining trials in due course. These trials will contribute to the combined pooled safety analysis, including major adverse cardiovascular event (MACE) outcomes, anticipated during H1 2019.

Sean Bohen, Executive Vice-President, Global Medicines Development and Chief Medical Officer, said: “These results add to the growing body of evidence for roxadustat, which is part of the largest clinical program worldwide in evaluating the novel class of HIF-PHI. This is a significant milestone in the role roxadustat can play to help address a high unmet need in anemia associated with chronic kidney disease, which today is under diagnosed and in many cases under treated.”

Data from the Phase III OLYMPUS and ROCKIES trials, together with the efficacy and pooled safety data from the rest of the global Phase III program, will be part of the regulatory submission package in the US and other major markets. Results from these trials will be presented at forthcoming medical meetings.

NOTES TO EDITORS

About roxadustat

Roxadustat is a first-in-class, orally-administered small-molecule medicine recently approved in China for the treatment of patients with anemia from CKD on dialysis. Roxadustat is a HIF-PHI that has the potential to promote erythropoiesis by increasing endogenous production of erythropoietin and downregulating hepcidin. Administration of roxadustat may induce coordinated erythropoiesis, increasing red blood cell count while maintaining plasma erythropoietin levels within or near normal physiologic range.

AstraZeneca and FibroGen, Inc. are collaborating on the development and commercialization of roxadustat for the treatment of anemia in patients with CKD in the US, China, and other global markets. FibroGen and Astellas Pharma Inc. are collaborating on the development and commercialization of roxadustat for the treatment of anemia in patients with CKD in Japan, Europe, the Commonwealth of Independent States, the Middle East, and South Africa.

About Anemia in CKD

Anemia is a serious medical condition in which patients have insufficient red blood cells and low levels of hemoglobin (“Hb”), a protein in red blood cells that carries oxygen to cells throughout the body. Anemia is associated with increased risk of hospitalization, cardiovascular complications and death. In addition, anemia frequently causes significant fatigue, cognitive dysfunction, and decreased quality of life. Anemia is common in patients with CKD and is often not effectively treated.

According to the United States Renal Data System, a majority of dialysis-eligible CKD patients in the US are currently on dialysis. Of the approximately 507,000 patients receiving dialysis in the US as of 2016, around 80% are being treated with ESAs for anemia. In clinical practice, patients typically do not receive ESA treatment for their anemia until they initiate dialysis.

About AstraZeneca in Cardiovascular, Renal & Metabolism (CVRM)

Cardiovascular, renal and metabolism together form one of AstraZeneca’s main therapy areas and a key growth driver for the Company. By following the science to understand more clearly the underlying links between the heart, kidneys and pancreas, AstraZeneca is investing in a portfolio of medicines to protect organs and improve outcomes by slowing disease progression, reducing risks and tackling co-morbidities. Our ambition is to modify or halt the natural course of CVRM diseases and potentially regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and cardiovascular health for millions of patients worldwide.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas - Oncology, Cardiovascular, Renal & Metabolism and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca-us.com and follow us on Twitter @AstraZenecaUS.

US-25495 Last Updated 12/18

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SOURCE: AstraZeneca

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PUB: 12/20/2018 06:17 AM/DISC: 12/20/2018 07:00 AM

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