SAN FRANCISCO, June 05, 2017 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN), a science-based biopharmaceutical company, announced today that a FibroGen European patent relating to the therapeutic use of certain small molecule inhibitors of hypoxia-inducible factor (HIF) prolyl hydroxylase was maintained by the European Patent Office.
Last week, the Opposition Division of the European Patent Office confirmed the patentability of claims in FibroGen’s European Patent Number 2322153, entitled “Use Of HIF Alpha Stabilizers For Enhancing Erythropoiesis.” The upheld claims relate to increasing serum iron in the treatment of iron deficiency and the use of structural mimetics of 2-oxoglutarate that inhibit HIF prolyl hydroxylase activity. The named opponents were Akebia Therapeutics, Inc., and three companies in the Bayer group (Bayer Intellectual Property GmbH, Bayer Pharma Aktiengesellschaft, and Bayer Animal Health GmbH). A further opposition filed by Glaxo Group Limited was deemed invalidly filed.
“We are pleased with this validation of FibroGen’s pioneering role in the development of HIF prolyl hydroxylase inhibitor therapeutics,” said Thomas B. Neff, Chief Executive Officer. “FibroGen has focused considerable effort on understanding the role of HIF in iron metabolism, and exploring the use of small molecule HIF prolyl hydroxylase (HIF-PH) inhibitors to modulate key aspects of this process. We see promise in the ability of HIF-PH-based therapies to treat iron deficiency, which can develop in many patients in the context of conditions including anemia, inflammation, and chronic kidney disease.”
Earlier in the week, the European Patent Office handed down a decision against related FibroGen European Patent No. 2322155, also entitled “Use Of HIF Alpha Stabilizers For Enhancing Erythropoiesis.” FibroGen has appealed the decision against the ‘155 patent, which is currently valid and enforceable pending resolution on appeal, expected to take three to four years. The ‘155 patent had been opposed by Akebia Therapeutics, Inc., three companies in the Bayer Group, and Glaxo Group Limited.
Roxadustat (FG-4592) is a first-in-class, orally administered small molecule currently in global Phase 3 clinical development as a potential therapy for anemia associated with chronic kidney disease (CKD). Roxadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) that promotes erythropoiesis through increasing endogenous erythropoietin, improving iron regulation, and reducing hepcidin. Administration of roxadustat has been shown to induce coordinated erythropoiesis – increasing red blood cell count while maintaining plasma erythropoietin levels within or near normal physiologic range in multiple subpopulations of CKD patients – including in the presence of inflammation and without a need for supplemental intravenous iron.
Roxadustat is currently advancing through Phase 3 clinical trials worldwide, supported by extensive Phase 2 clinical data demonstrating correction and maintenance of hemoglobin levels in multiple subpopulations of CKD anemia patients. To date, roxadustat has been evaluated in Phase 1 and Phase 2 studies involving more than 1,400 subjects. Globally, a total of 17 studies are currently underway involving a total of more than 11,000 patients. Of these, 15 are Phase 3 pivotal studies comprising 10,400 patients, and are currently being conducted to support independent regulatory approvals of roxadustat in both non-dialysis and dialysis CKD patients in the U.S., Europe, Japan, and China. Later this year, roxadustat will also enter a Phase 3 clinical trial in the U.S., and a Phase 2/3 trial in China, for the treatment of anemia in patients with myelodysplastic syndromes (MDS). For further information about roxadustat studies currently recruiting patients, please visit www.clinicaltrials.gov.
About FibroGen, Inc.
FibroGen, Inc., headquartered in San Francisco with subsidiary offices in Beijing and Shanghai, PRC, is a leading science-based biopharmaceutical company discovering and developing a pipeline of first-in-class therapeutics. The company applies its pioneering expertise in fibrosis and hypoxia-inducible factor (HIF) 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 Phase 3 clinical development for the treatment of anemia in chronic kidney disease (CKD) and is entering Phase 3 development for anemia in lower risk myelodysplastic syndromes (MDS). Pamrevlumab, a fully-human monoclonal antibody that inhibits the activity of connective tissue growth factor (CTGF), is in Phase 2 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), pancreatic cancer, and Duchenne muscular dystrophy (DMD). FibroGen is also developing a biosynthetic cornea in China. For more information, please visit www.fibrogen.com.
This release contains forward-looking statements regarding our strategy, future plans, and prospects, including statements regarding the development of the Company's product candidates, roxadustat and pamrevlumab. 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,” “should,” “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 non-clinical and clinical programs, including our Phase 3 trials and our collaboration partners’ clinical trials for roxadustat in anemia associated with CKD, the appeal of the European Patent Office decision against the ‘155 patent, and other matters that are described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2016, and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, 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.
Karen L. Bergman
Vice President, Investor Relations and Corporate Communications