FORMAC obtains EMA Orphan Drug Designation for its FP110 program
FORMAC is pleased to announce that the European Medicines Agency has granted Orphan Drug Designation to FORMAC's FP110 program on March 9, 2011. It follows a similar decision from FDA back in 2008.
This announcement is another important milestone for the program, following the promising results obtained during a phase 2A clinical trial with patients suffering from pouchitis. Pouchitis is a debilitating condition for which there is no approved treatment and the EMA's decision also reflects the high unmet medical need for patients suffering from this condition.
"We made excellent progress in securing the additional data needed to make this product available for licensing" says Laurent Schueller, FORMAC's Chief Operating Officer "and we will intensify our discussions with identified potential partners for this promising and important product".