On March 1, 2017 FibroGen, Inc. (NASDAQ:FGEN), a science-based biopharmaceutical company, reported financial results for the year ended December 31, 2016, and provided an update on the company’s recent developments (Press release, FibroGen, MAR 1, 2017, View Source [SID1234517929]).

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"We are pleased with the topline results reported from our two China Phase 3 trials, which are the first Phase 3 readouts for roxadustat, and bring us closer to completing our new drug application submission in China. With our partners AstraZeneca and Astellas, we are making steady progress in Phase 3 clinical development worldwide for roxadustat in CKD anemia, and continue to expect filing of our U.S. NDA in 2018," said Thomas B. Neff, FibroGen’s Chief Executive Officer. "This year, we are expanding development activities for roxadustat into oncology-related anemias. We are also anticipating important clinical milestones for pamrevlumab, or FG-3019. We began the year with the presentation and publication of promising clinical results in pancreatic cancer, and expect to report data from our placebo-controlled Phase 2 trial in idiopathic pulmonary fibrosis in the third quarter of this year."

Recent Developments
U.S. and Europe Roxadustat (FG-4592) Anemia in Chronic Kidney Disease (CKD)

Met initial target enrollment for three FibroGen-sponsored Phase 3 trials supporting U.S. and EU approvals and are continuing to enroll patients to meet overall enrollment goals among the partners
The independent data safety monitoring board (DSMB), which reviews the U.S. and European Phase 3 program quarterly, recommended in February that trials continue without modification to current protocols
China Roxadustat Anemia in Chronic Kidney Disease

Completed the controlled portion of our two Phase 3 trials in 2016
These studies met their primary endpoints for the treatment of anemia in non-dialysis and dialysis patients
— In non-dialysis patients, roxadustat achieved a significantly greater increase in mean Hb and a significantly greater Hb response rate, as compared to patients in the placebo arm
— In dialysis patients, roxadustat met the predefined non-inferiority criteria for the primary efficacy endpoint. In the pre-specified sequential analysis, roxadustat was also shown to be superior to 利血宝 (Li Xue Bao) epoetin alfa (Kirin EPO) in mean Hb increase
Japan Roxadustat Anemia in Chronic Kidney Disease

All six Phase 3 trials are now underway
Presented Phase 2 study results in non-dialysis-dependent patients in a clinical late-breaker session of the November 2016 American Society of Nephrology (ASN) Kidney Week
U.S. Roxadustat Oncology-Related Anemias

Phase 3 investigational new drug application was approved by the FDA for the treatment of anemia in myelodysplastic syndromes (MDS) in the fourth quarter of 2016
China Roxadustat Oncology-Related Anemias

Submitted a clinical trial application (CTA), which is under review by the China Food and Drug Administration (CFDA), for a Phase 2/3 clinical study of anemia in MDS
Pamrevlumab in Idiopathic Pulmonary Fibrosis (IPF)

Completed enrollment of the Phase 2 double-blind, placebo-controlled -067 study
Results from Study -049 were published in the European Respiratory Journal, accompanied by an editorial, and the corresponding open-label extension results were presented at the 19th International Colloquium on Lung and Airway Fibrosis (ICLAF)
— No safety issues reported with long-term treatment
— Trend towards improved or stable pulmonary function and stable fibrosis continued in second year of treatment
Pamrevlumab in Pancreatic Cancer

Presented findings at the 2017 Gastrointestinal Cancers Symposium (ASCO-GI) from an ongoing open-label, randomized Phase 1/2 study in locally advanced pancreatic cancer -069 showing improvement in survival among patients in the combination arm, as compared to chemotherapy alone
Published Phase 1/2 trial results in the Journal of Cancer Clinical Trials reporting statistically significant dose-related increase in survival and that pamrevlumab can be safely combined with chemotherapy standard-of-care in advanced pancreatic cancer
Corporate and Financial Highlights

Net loss per basic and diluted share for the year ended December 31, 2016 was $0.98, as compared to $1.42 a year ago
At December 31, 2016, FibroGen had $342.2 million of cash, restricted time deposits, cash equivalents, investments, and receivables
Outlook

Report pamrevlumab topline Phase 2 IPF data, placebo-controlled and combination treatment sub-study results, in the third quarter
Submit new drug application in China in the third quarter
Expect to complete enrollment of pamrevlumab open-label, randomized Phase 2 trial in locally advanced pancreatic cancer patients in the first half of the year, and to complete the patient treatment period by year-end
On track to submit the NDA for roxadustat in the U.S. in 2018