SAN FRANCISCO, June 29, 2015 (GLOBE NEWSWIRE) -- FibroGen, Inc. (Nasdaq:FGEN), a research-based biopharmaceutical company, announced today that it has received a scheduled $120.0 million non-contingent license payment from AstraZeneca AB ("AstraZeneca") under its collaboration agreements with AstraZeneca for roxadustat in the United States, China and certain other territories.
In addition to this non-contingent license payment of $120.0 million, as previously announced, FibroGen received a $15.0 million milestone payment from AstraZeneca during the second quarter of 2015 in connection with the completion of long-term preclinical safety studies of roxadustat. On a pro-forma basis, FibroGen expects to have approximately $410 million to $415 million of cash, cash equivalents, investments, and receivables on June 30, 2015 (unaudited).
Roxadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) that acts by stimulating the body's natural pathway of red blood cell production, or erythropoiesis. Roxadustat is the first HIF-PHI to enter Phase 3 clinical development and represents a novel approach to the treatment of anemia in patients with chronic kidney disease (CKD), with the potential to address the considerable unmet medical need for an effective treatment for anemia that offers the convenience of oral administration and an improved safety profile as compared to current standards of care.
Roxadustat is currently in Phase 3 global development for the treatment of anemia in patients with chronic kidney disease (CKD) on dialysis and not on dialysis. The global development program is being conducted by FibroGen and its partners, AstraZeneca and Astellas Pharma Inc. Approximately 8,000 CKD patients will be enrolled in 10 clinical trials. Regulatory filings are expected to be submitted in 2016 for China and in 2018 for the US.
FibroGen is a research-based biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics to treat serious unmet medical needs. The company utilizes its extensive experience in fibrosis and hypoxia-inducible factor (HIF) biology to generate development programs in multiple therapeutic areas. Its most advanced product candidate, roxadustat, or FG-4592, is an oral small molecule inhibitor of HIF prolyl hydroxylases, or HIF-PHs, in Phase 3 clinical development for the treatment of anemia in CKD. A second product candidate, FG-3019, is a monoclonal antibody in Phase 2 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), pancreatic cancer and liver fibrosis.
Forward Looking Statements
This release contains forward-looking statements, including statements regarding the potential for continued safety of roxadustat and our expectations regarding the timing for regulatory filings in China and the US. Our actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties, including the continued progress and timing of the Phase 3 clinical trials for roxadustat; the potential to achieve and receive remaining milestones from our collaborators; the continued progress of our plans and programs in China; and other matters that are described in our Annual Report on Form 10-K and our quarterly report on Form 10-Q filed with the Securities and Exchange Commission, 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.
CONTACT: FibroGen, Inc. Greg Mann, 415-978-1433 firstname.lastname@example.org