Galapagos NV and Enceladus Pharmaceuticals BV announce 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 €25 million.
Nanocort is a novel pharmaceutical, developed by Enceladus for the treatment of acute RA flares. It is complementary to Galapagos’ present R&D program in RA that focuses on chronic treatment. Nanocort is composed of a widely used corticosteroid enclosed in small lipid vesicles (liposomes). Corticosteroids are the most common treatment for RA-related flares, but their use as a free drug is limited due to systemic side effects.
In the Nanocort treatment, the corticosteroid is confined to the liposome in the blood stream. After injection, the Nanocort liposomes selectively accumulate and form local depots at sites of inflammation, from which the corticosteroid can perform its beneficial local effects. As a result, Nanocort should be able to significantly reduce frequency of administration and +use of the steroid compared to other therapies.
Both the anti-inflammatory drug and the liposomes have separately been extensively used in the clinic and have proven to be safe. Nanocort is currently in a Phase I/II investigator-led study in the Netherlands which will read out later this year.
Galapagos intends to file an IND application in Q1 2009, and initiate an international multi-center Phase II study shortly thereafter. Clinquest, a product development organization for clinical trials, will be involved in the development of Nanocort. The primary therapeutic indication for Nanocort will be the treatment of flares in RA, but Galapagos will also pursue development in multiple sclerosis and inflammatory bowel disease patients.
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.