Under the terms of the agreement, Galapagos will pay Enceladus an upfront fee and run the clinical development of Nanocort. Enceladus will receive a minority share of future revenues received by Galapagos from the commercialization of Nanocort.
Galapagos intends to file an investigational new drug (IND) application in the first quarter of 2009, and initiate a Phase II study shortly thereafter. Galapagos plans to seek approval as early as 2012, potentially using shortened registration procedures.
Nanocort is a novel pharmaceutical, developed by Enceladus for the treatment of acute rheumatoid arthritis (RA) flares. It is complementary to Galapagos’s present R&D program in RA that focuses on chronic treatment.
Onno Stolpe, CEO of Galapagos, said: “This program rounds out our therapeutic approach for RA, encompassing acute flare treatment through Nanocort and chronic oral treatment with our GT418 first in class kinase program. It contributes to our goal to build a comprehensive clinical pipeline of risk-balanced programs in RA.”