AstraZeneca ($AZN) has released $62 million for a license payment to partner FibroGen ($FGEN) as its experimental pill roxadustat continues its late-stage testing for anemia in kidney disease patients.
The drug, which is made up from the active ingredient FG-4592, has been used in the past for so-called "blood doping" by athletes--especially professional cyclists.
It works by helping the transcription factors that control the amount of oxygen in cells, thereby spurring the body to naturally generate more red blood cells and thus battle the underlying cause of anemia. This can, in top-end athletes, also help them gain an advantage.
Companies using the drug, such as San Francisco’s FibroGen, require written confirmation that what they sell is for lab tests only, adding an extra layer of complexity to its studies.
But last year, the Italian pro cyclist Fabio Taborre (Androni Giocattoli) tested positive for the treatment’s active ingredient and was given a provisional suspension.
On its legal and medical rota, roxadustat has been undergoing a global Phase III program over the past year, with AstraZeneca assisting in U.S. and Chinese development (with an approval by the China FDA expected within the year), while Astellas holds the rights in Japan, Europe and the Middle East.
FibroGen expects to submit for U.S. approval in 2018 for a license to treat anemia in patients with CKD and end-stage renal disease.
AstraZeneca paid $350 million in 2013 to in-license U.S. and China rights for roxadustat, with a potential $115 million more in milestones to come.
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