Full Press Release Details
ASN Kidney Week 2018: Data Presented from
Two Japanese Phase 3 Studies on Roxadustat in
the Treatment of Anemia Associated with
Chronic Kidney Disease in Patients on Dialysis
TOKYO and San Francisco, October 30, 2018 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D.,
Astellas ) and FibroGen, Inc. (Nasdaq: FGEN, CEO: Thomas B. Neff, FibroGen ) today announced the presentation of data from two Japanese Phase 3 studies
(1517-CL-0302 and 1517-CL-0307) of roxadustat (development code: ASP1517/FG-4592) for the treatment of anemia associated with Chronic Kidney Disease (CKD) in patients on dialysis at the American Society of Nephrology (ASN) Kidney Week 2018 that was held October 23 28,
2018 in San Diego, California.
The 1517-CL-0302 study evaluated the
efficacy and safety of roxadustat in Japanese CKD patients on peritoneal dialysis (PD). In this study, roxadustat was well tolerated and achieved and maintained hemoglobin (Hb) levels within the target range in Japanese CKD patients on PD, with or
without previous treatment with erythropoiesis-stimulating agents (ESAs). The 1517-CL-0307 study evaluated the efficacy and safety of roxadustat compared to darbepoetin
alfa (genetical recombination) ( darbepoetin alfa ) in the treatment of CKD anemia in patients on hemodialysis (HD) who had previously been treated with recombinant human erythropoietin (rHuEPO) or darbepoetin alfa. In this study,
roxadustat effectively maintained Hb within the range of 10-12 g/dL in HD patients, and its efficacy was non-inferior to darbepoetin alfa. In both studies, the safety
profile of roxadustat was consistent with previous studies in the CKD population.
Anemia, a common complication of CKD, is associated with
significant morbidity and mortality, and the condition can have a debilitating impact on the patients affected, said Salim Mujais, M.D., senior vice president and global therapeutic area head, Medical Specialties Development, Astellas.
The presented data from two Phase 3 studies conducted in Japanese patients, showing roxadustat to be well tolerated and efficacious, support the potential of roxadustat as a new oral therapeutic option for CKD patients with anemia, including
those on HD and on PD. We look forward to continuing to advance the development of roxadustat and contributing to a treatment of anemia associated with CKD.
The following are highlights of key data from these two Phase 3 studies of roxadustat:
Title: Phase 3, Multicenter, Open-Label Study of Intermittent Oral Roxadustat in Peritoneal Dialysis CKD Patients with Anemia
(Publication #: SA-OR075, Oral abstract session on Saturday, October 27 from 5:54 p.m. to 6:06 p.m. PT at San
Diego Convention Center, Room 2)
Title: Phase 3, Randomized, Double-Blind, Active-Comparator (Darbepoetin Alfa) Conversion Study of Oral Roxadustat in CKD Patients with Anemia on
Hemodialysis in Japan
(Publication #: TH-PO1151, Poster session on Thursday, October 25 from 10:00 a.m.
to 12:00 noon PT at Exhibit hall)
For more information about roxadustat studies, please visit to clinicaltrials.gov at:
About Chronic Kidney Disease (CKD) and Anemia
estimated to affect more than 200 million people worldwide*1 and specifically in Japan, the prevalence of CKD has increased significantly over time.*2 Although CKD can occur at any age, it becomes more common in aging populations, and the prevalence is increasing. Anemia is a common complication of CKD and is associated with significant morbidity
and mortality in dialysis and non-dialysis populations. In addition, CKD can be both a cause and a consequence of cardiovascular disease and is now a critical worldwide healthcare issue that represents a large
and growing unmet medical need.
Roxadustat, discovered and developed by FibroGen, is a compound currently in Phase 3 development on a global basis as a potential therapy for anemia associated
with CKD in both patients on dialysis and not on dialysis. Roxadustat is an orally administered small molecule inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase activity. HIF is a protein transcription factor that induces the natural
physiological response to conditions of low oxygen, turning on erythropoiesis (the process by which red blood cells are produced).
and FibroGen are collaborating on the development of roxadustat for the potential treatment of anemia in patients with CKD and myelodysplastic syndromes in territories including Japan, Europe, the Commonwealth of Independent States, the Middle East,
and South Africa. FibroGen and AstraZeneca are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in patients with CKD in the U.S., China, and other markets.
Roxadustat is currently in Phase 3 clinical development for the treatment of anemia associated with myelodysplastic syndromes (MDS) in the U.S. and in Phase
2/3 development for MDS in China.
For information about roxadustat studies, please visit clinicaltrials.gov at this link:
Astellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and
reliable pharmaceutical products. For more information, please visit our website at https://www.astellas.com/en
FibroGen, Inc., headquartered in San Francisco, with subsidiary offices in Beijing and Shanghai, is a leading biopharmaceutical company discovering and
developing a pipeline of first-in-class therapeutics. The company applies its pioneering expertise in hypoxia-inducible factor (HIF), 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 candidate, is an oral small molecule inhibitor of HIF
prolyl hydroxylase activity, completing worldwide Phase 3 clinical development for the treatment of anemia in chronic kidney disease (CKD), with a New Drug Application (NDA) currently under review by the State Drug Administration (SDA). 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). Pamrevlumab, an anti-CTGF human monoclonal antibody, is advancing towards Phase 3
clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and pancreatic cancer, and is currently in a Phase 2 trial for Duchenne muscular dystrophy (DMD). FibroGen is also developing a biosynthetic cornea in China. For more
information, please visit www.fibrogen.com.
Astellas Cautionary Notes
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are
forward-looking statements about the future performance of Astellas. These statements are based on management s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and
uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and
regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of
Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas intellectual property rights by third parties.
Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute
an advertisement or medical advice.
FibroGen Forward-looking Statements
This release contains forward-looking statements regarding FibroGen s strategy, future plans, and prospects, including statements regarding the
development of the company s product candidates pamrevlumab and roxadustat, the potential safety and efficacy profile of our product candidates, and our clinical, regulatory, and commercial plans, 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, 2017, and our Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2018, 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
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