The European Agency for the Evaluation of Medicinal Products (EMEA) established small and medium-sized enterprise (SME) as a dedicated office in 2005 to provide special assistance to small and medium-sized enterprises. SME status entitles Siga to certain fee reductions or deferrals, including reduced fees for scientific advice and certain administrative services of the EMEA, and a deferral of the fee payable for an application for marketing authorization.
ST-246 is a smallpox antiviral and Siga’s lead product candidate. SIGA has also initiated the process for obtaining marketing authorization with ST-246 with the EMEA, which is the European equivalent of the FDA. In addition, Siga engaged the SME Office in a pre-submission meeting to discuss development of ST-246 in Europe.
Eric Rose, CEO of Siga Technologies, said: “Obtaining SME status is a significant achievement in our pursuit of European regulatory approval for ST-246. SIGA will continue to work closely with the EMEA in the coming months as it moves forward in its efforts to obtain marketing authorization in Europe for ST-246.”