Formac receives final advice letter from the European Medicines Agency
Leuven, Belgium – 17 June 2013 Formac Pharmaceuticals NV, a drug delivery company focused on developing innovative formulations for poorly water-soluble drugs, today announced that it has received positive feedback from the European Medicines Agency (EMA) regarding the use of its proprietary Ordered Mesoporous Silica material as a new pharmaceutical excipient.
“The positive and constructive feedback of the scientific advice with EMA is in line with the positive feedback received earlier from the Belgian Federal Agency for Healthcare and Medicinal products (FAHMP) . This is a very strong signal towards our customers about the de-risked approach of bundling their clinical assets to Formac's technology.” Commented Laurent Schueller, Formac’s CEO
Companies involved in developing new drug products can request scientific advice from the EMA. The EMA gives advice to companies on the appropriate tests and studies in the development of a drug product. This procedure is designed to facilitate the development and availability of high-quality, effective and acceptably safe medicines, for the benefit of patients.