On November 8, 2017 FibroGen, Inc. (NASDAQ:FGEN), a science-based biopharmaceutical company, today reported financial results for the third quarter of 2017 and provided an update on the company’s recent developments (Press release, FibroGen, NOV 8, 2017, View Source;p=RssLanding&cat=news&id=2315520 [SID1234521792]).
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"We have achieved significant clinical and regulatory progress in FibroGen’s product development programs. With the reporting of positive data from our placebo-controlled Phase 2 study of pamrevlumab for the treatment of moderate-to-severe idiopathic pulmonary fibrosis, we are very excited about the potential for pamrevlumab to help IPF patients who currently have few options. These results position us well on the path towards Phase 3 clinical development in IPF, as we continue to advance pamrevlumab in additional indications, where there is critical need for new therapies," said Thomas B. Neff, FibroGen’s Chief Executive Officer. "With respect to roxadustat, the filing of our new drug application with the China Food and Drug Administration for the treatment of anemia associated with chronic kidney disease marks several important firsts for FibroGen, the HIF-PHI class of drugs, and towards the registration of a new chemical entity in China."
Recent Developments and Highlights
Pamrevlumab for Idiopathic Pulmonary Fibrosis (IPF)
Announced positive results from a randomized, placebo-controlled, double-blind Phase 2 study of pamrevlumab, a first-in-class fully human antibody targeting connective tissue growth factor (CTGF)
Presented Phase 2 findings in an oral presentation at the European Respiratory Society (ERS) International Congress in September 2017
Results also presented at the ERS meeting from a preclinical mouse radiation-induced lung fibrosis model showed that pamrevlumab monotherapy reduced fibrosis to a greater extent than either pirfenidone or nintedanib monotherapy, and that the results of combination therapy with either standard-of-care were not statistically significantly better than those for pamrevlumab alone
Clinical and preclinical data has been accepted for presentation in November 2017 at Pulmonary Fibrosis Foundation (PFF) Summit 2017 in Nashville, TN
Pamrevlumab for Pancreatic Cancer
We expect to define a registrational strategy in the first half of 2018
Roxadustat for Anemia in Chronic Kidney Disease (CKD)
New drug application (NDA) filing with the U.S. Food and Drug Administration targeted for 2018
Positive topline results reported from the first completed Japan roxadustat Phase 3 CKD trial, for the treatment of anemia in peritoneal dialysis patients in October 2017
In November 2017, the independent data safety monitoring board, which reviews the U.S. and European Phase 3 programs quarterly, recommended that all trials continue without modification to current protocols
Roxadustat for Anemia in Myelodysplastic Syndromes (MDS)
Phase 3 U.S. clinical trial anticipated to start in the fourth quarter of 2017
Roxadustat for Anemia in CKD in China
NDA accepted for review by the China Food and Drug Administration (CFDA) for anemia associated with CKD in dialysis-dependent and non-dialysis-dependent patients in October 2017
Twenty-six week data from the two Phase 3 trials showed correction of anemia and maintenance of hemoglobin levels, and comparable results with or without inflammation
Data from the fifty-two week safety extension study showed durability of effect
No safety signals were identified
Roxadustat for Anemia in MDS in China
Initiation of Phase 2/3 clinical study is planned for the fourth quarter of 2017/first quarter of 2018
Corporate and Financial Highlights
Appointed Gerald Lema to the company’s Board of Directors, adding extensive experience to FibroGen’s leadership in commercialization, finance, and strategy in the Asia Pacific region, as well as in Europe/Middle East and Africa, U.S., and Latin America
Earned $15.0 million milestone from partner AstraZeneca for the submission of the NDA for roxadustat in CKD to the CFDA in October 2017, which will be received and recognized as license and milestone revenue in the fourth quarter of 2017
Closed an equity financing in August 2017 that generated $356.2 million in net proceeds
Net loss per basic and diluted share for the quarter ended September 30, 2017 was $0.50, as compared to a net loss per based and diluted share of $0.38 a year ago
At September 30, 2017, FibroGen had $762.7 million of cash, restricted time deposits, cash equivalents, investments, and receivables
Conference Call Details
FibroGen will host a conference call and webcast today, November 8, 2017, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss financial results and provide a business update. A live audio webcast of the call may be accessed in the investor section of the company’s website, www.fibrogen.com. To participate in the conference call by telephone, please dial 1 (888) 771-4371 (U.S. and Canada) or 1 (847) 585-4405 (international), reference the FibroGen Third Quarter 2017 conference call, and use the confirmation number 45903141. A replay of the webcast will be available shortly after the call for a period of two weeks. To access the replay, please dial (888) 843-7419 (domestic) or (630) 652-3042 (international), and use the passcode 45903141#.