British drugmaker AstraZeneca and US biotechnology company FibroGen have formed a strategic partnership to develop and commercialize FG-4592 to treat anemia in patients with chronic kidney disease (CKD) and end-stage renal disease (ESRD).
FG-4592 is an orally administered small molecule inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase activity.
As part of the agreement, the deal will focus on US, China and all major markets except the Commonwealth of Independent States, the Middle East, South Africa, Japan and Europe, while both companies can exercise the option to extend their collaboration to other anemia indications.
FibroGen CEO Thomas Neff said, "This agreement secures proper development and commercialization resources for FG-4592, and ensures US clinical trial efforts are fully funded."
Pursuant to the agreement, AstraZeneca will pay FibroGen committed upfront and subsequent non-contingent payments totaling $350m, and potential future development related milestone payments of up to $465m.
FibroGen will also be eligible for potential future sales related milestone payments in addition to tiered royalty payments on future sales on FG-4592 in the low 20% range.
While AstraZeneca will be responsible for the US commercialization of FG-4592, FibroGen will focus on specified promotional activities in the ESRD segment in this market.
In China, FibroGen will be responsible for clinical trials, regulatory matters, manufacturing and medical affairs, while AstraZeneca will oversee promotional activities and commercial distribution.
As part of the deal, the two drug makers intend to conduct Phase III development program for FG-4592 for the US, and initiate Phase III trials in China. The companies expect to put up regulatory filings in China and US in 2015 and 2017, respectively.
