The deal grants Aska the option to develop and commercialize the drug in Japan and other Asian markets.
Pieris was paid $2.75m (€2.59m) upfront for the option and stands to earn more than $80m in developmental and regulatory milestones if the option is exercised.
PRS-080 is a modified lipocalin protein that inhibits hepcidin, a polypeptide regulator of the iron metabolism. An excess of the protein in patients with kidney disease prevents iron uptake.
The idea is that PRS-080 is used to treat anaemia in kidney disease patients an alternative to current therapies like high dose erythropoietin stimulating medicines.
A spokesman for Pieris told us PRS-080 is “produced in a high-quality E. coli expression system, which is cheaper than mammalian production” adding the drug "is subsequently PEGylated for half-life extension.”
At present PRS-080 is made on Pieris’ behalf by an unnamed contract manufacturing organisation (CMO). The contractor is likely to be supply Aska in the short term according to the spokesman.
“Aska and Pieris will negotiate future supply arrangements during the ASKA option period but ASKA will be responsible for all costs related to drug supply in its territory and will also be responsible for its own market supply” he said.
Pieris has completed dosing in a Phase Ib study in CKD patients on hemodialysis and will pursue a multi-dose, Phase IIa study in the same population, in the second half of 2017.