Biotech company Pharming Group receives confirmation of validation for Rhucin

Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today received confirmation of validation from EMEA of its Marketing Authorization Application (MAA) for Rhucin®. This means that the formal scientific evaluation procedure of the European Medicines Agency (EMEA) has started today.

Pharming submitted the MAA for Rhucin to EMEA earlier this month. Today, the EMEA notified the Company that it has completed the validation of the dossier. As result of this, the Centralized Procedure for scientific evaluation of the MAA by the Committee for Medicinal Products for Human Use (CHMP) has started today. According to the standard timetable of the Centralized Procedure, the CHMP adopts a List of Questions at Day 120. This List of Questions is based on the Day 80 Assessment Report from the Rapporteur and Co-Rapporteur. The Company should submit its responses to these questions within 3 months, after which the 'clock' will restart and the procedure will be continued. Pharming may expect the adoption of the final CHMP opinion within a total of 210 days review time (excluding any clock-stops).. More information on this procedure can be found on


Pharming Group N.V.


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