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Astellas and FibroGen Announce Topline Results from Double-Blind Japan Phase 3 Study for Roxadustat in Hemodialysis Chronic Kidney Disease Patients with Anemia

TOKYO and San Francisco, May 31, 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 that  the fourth Japan Phase 3 study for roxadustat met its  primary endpoint. This study evaluated the efficacy and safety of roxadustat  compared to darbepoetin alfa (genetical recombination) ("darbepoetin  alfa") in hemodialysis-dependent chronic kidney disease (CKD)  patients with anemia and previously treated with recombinant human  erythropoietin (rHuEPO) or darbepoetin alfa.

"We are encouraged by these positive data from our Phase 3 key study  in Japan, and are pleased with our overall development progress to date in the  region," said Salim Mujais, M.D.,  senior vice president and global therapeutic area head, Medical Specialties  Development, Astellas. "We look forward to continuing to advance the  development of roxadustat to hopefully provide the value of a new therapeutic  option to patients suffering from CKD with anemia."

"The positive topline results from this latest Japan Phase 3  study are consistent with previously reported results from roxadustat Phase 3 studies  in Japan and in China, and from our extensive Phase 2 program," said K. Peony  Yu, M.D., Chief Medical Officer, FibroGen. "We are pleased with the growing  body of clinical evidence showing roxadustat to be well tolerated and  efficacious in treating anemia in CKD patients, including patients on  hemodialysis and those on peritoneal dialysis in various regions worldwide."

In the study, average  hemoglobin (Hb) levels were effectively maintained at 10.99 g/dL at Weeks  18 to 24 in roxadustat-treated hemodialysis patients previously treated with erythropoiesis-stimulating  agents (ESAs). The primary efficacy endpoint  of change in average Hb levels from baseline to Weeks 18 to 24 was -0.04 g/dL  and -0.03 g/dL in the roxadustat-treated group and in the darbepoetin-treated  group, respectively. The non-inferiority of roxadustat to darbepoetin alfa in change  of average Hb from baseline was confirmed as the lower bound of the 95%  confidence interval (-0.18, 0.15) of the treatment difference was greater than  the pre-specified non-inferiority margin (-0.75 g/dL).

Roxadustat was  well tolerated in this study, and the safety profile of roxadustat was  consistent with that observed in previous studies both in dialysis and  non-dialysis patients.

Further detailed data from this study are expected to be  reported in the future.
Astellas is a sponsor of a total of six Phase 3 studies of  roxadustat in Japan for anemia associated with CKD in both dialysis and  non-dialysis patients. This study is the final Phase 3 study in  Japan evaluating roxadustat for the treatment of anemia in CKD  patients on dialysis. Astellas is  planning the submission of the new drug application in Japan for this  indication later this year. The two Japan Phase 3 studies in non-dialysis  patients are ongoing.

About the Study
The multi-center, randomized, darbepoetin alfa-controlled, double-blind Phase 3  study enrolled a total of 303 hemodialysis chronic kidney disease patients with  anemia converted from rHuEPO or darbepoetin alfa. Subjects randomized to the roxadustat  treatment arm received roxadustat three times a week orally  and darbepoetin  alfa placebo. Subjects randomized to the darbepoetin alfa treatment arm received  darbepoetin-alfa once a week intraveneously and roxadustat placebo. The primary  efficacy endpoint is change of average Hb levels from baseline during the  evaluation period of Weeks 18 to 24.

About Chronic  Kidney Disease
CKD affects more than 200 million people worldwide and specifically in Japan, the prevalence of CKD has  increased significantly over time. Although it 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. Currently, no curative treatment or ability to stop  kidney deterioration in patients with CKD exists with the exception of kidney transplantation.

About Roxadustat
Roxadustat is currently in Phase 3 development 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).

Astellas and  FibroGen are collaborating on the development and commercialization of  roxadustat for the treatment of anemia in patients with CKD 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  patients with CKD in the U.S., China, and other markets. Roxadustat is also in  clinical development for anemia in MDS. For information about roxadustat  studies that are currently recruiting patients, please visit  at this link:

About Astellas
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

About FibroGen
FibroGen, Inc., headquartered in San Francisco, California, with subsidiary  offices in Beijing and Shanghai, People's Republic of China, is a leading  science-based 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 in worldwide Phase 3 clinical development  for the treatment of anemia in chronic kidney disease (CKD), except in China,  where a New Drug Application is currently under review by the State Drug  Administration, or SDA (formerly the China Food and Drug Administration, or  CFDA). Roxadustat is also in Phase 3 clinical development in the U.S. and  Europe 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

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 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 March 31, 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 as required by law. 


Contacts for inquiries or additional information:
Astellas  Pharma Inc.
Corporate Communications
TEL: +81-3-3244-3201 FAX: +81-3-5201-7473

FibroGen,  Inc.
Karen L. Bergman
Vice President, Investor Relations and Corporate Communications
1 (415) 978-1433

1Ojo, A.  Addressing the Global Burden of Chronic Kidney Disease Through Clinical and  Translational Research. Transactions of the American Clinical and Climatological  Association. 2014; 125: 229-246.
2Nagata M, Ninomiya T, Doi Y, Yonemoto  K, Kubo M, Hata J, Tsuruya K, Iida M, Kiyohara Y. Nephrol Dial Transplant. 2010 Aug; 25(8):2557-64.