FibroGen gets $15M from AZ as it advances roxadustat candidate toward China nod

AstraZeneca ($AZN) made a $15 million milestone payment to U.S.-based FibroGen ($FGEN) as it works on moving to file for China FDA approval for roxadustat, an anemia candidate in clinical trials, as early as next year.

AstraZeneca paid $350 million in 2013 to in-license U.S. and China rights for roxadustat, with a potential $115 million more in milestones.

If the drug wins approval under a new drug application expected in 2016, AstraZeneca will market the drug in China, ahead of a U.S. filing is seen in 2018.

The candidate for treating anemia in patients with CKD and end-stage renal disease would see FibroGen get a tidy 20% royalty on U.S. sales and split profits equally with AZ for sales in China. It also stands to gain other sales-related milestones.

"The partnership means that, in combination with our Astellas collaborations, we expect that the future costs of FG-4592 development and commercialization for the treatment of anemia in CKD patients in the U.S., Europe, China, and Japan should be fully funded," FibroGen spokesman Greg Mann said in an email to FierceBiotech in 2013.

"We expect to receive substantial cash payments from AstraZeneca during the pre-NDA submission phase for FG-4592."

- here's the release from FibroGen

Special Report: FierceBiotech's 2013 Fierce 15 - FibroGen