Galapagos NV: business update: http://t.co/6w1jppWE
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FORMAC Pharmaceuticals N.V., a Belgian-based drug development company, is pleased to announce that the European Medicines Agency (EMA) has granted Orphan Drug Designation to FORMAC's FP110 on March 9, 2011. An orphan drug is a drug for a rare disease.
This Orphan Drug Designation follows a similar decision from the Food & Drug Administration (FDA). It 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 clinical data ", says Jan Rosier, FORMAC's Chief Executive Officer, "and we have started negotiations with identified potential partners to make this promising and important product available to patients".
FORMAC Pharmaceuticals NV is a pharmaceutical R&D company engaged in new drug development. The company owns patents related to a bio-availability-enhancing silica-based drug delivery technology for the formulation of poorly soluble drugs, preclinical drug candidates and line extensions. FORMAC was created in October 2007 as a spin-off from K.U.Leuven, Belgium.
Source: FORMAC Pharmaceuticals
Tags: clinical trials, regulatory
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