Galapagos licenses clinical rheumatoid arthritis program
Galapagos NV and Enceladus Pharmaceuticals BV announced the in-licensing of Nanocort by Galapagos. Nanocort is a patented liposome-formulation of prednisolone to treat inflammatory diseases, in particular for the acute treatment of flares in rheumatoid arthritis (RA). Nanocort is currently in a Phase I/II study. Galapagos intends to file an Investigational New Drug (IND) application in Q1 2009, and initiate a Phase II study shortly thereafter. Galapagos plans to seek approval as early as 2012, potentially using shortened registration procedures. It is expected that the license and the program costs for 2008 will not impact Galapagos' guidance for 2008 year end cash position of approximately EUR 25 million.
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.
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