Pharming receives EMA approval of new facility for expansion of RUCONEST® production

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Overig advies 21/01/2020 07:49
•New production facility will significantly increase production capacity of RUCONEST®
•Product manufactured at the new facility during the approval process is now available for distribution within the EU

Leiden, the Netherlands – 21 January 2020

Pharming Group N.V. (Euronext Amsterdam: PHARM) today announced it has received European Medicines Agency (EMA) approval of a Type II Variation for a new production facility for the Company’s lead product, RUCONEST®.

With the addition of this new facility, Pharming will significantly increase the production capacity of RUCONEST® as it becomes fully operational over the coming year. Pharming is now also able to release the product that was manufactured at the facility during the approval process for commercialisation in the EU. As previously announced, Pharming had identified a potential risk of short-term pressure on the supply of RUCONEST® for the European market due to increasing demand for the product. With the approval of this new facility, the Company believes the risk to supply is now greatly reduced.

The new facility’s post-approval supplement (PAS) for the distribution of RUCONEST® in the US is still under review by the Food and Drug Administration (FDA). Approval of the new facility for distribution in the US is expected in H1 2020.

Sijmen de Vries, Pharming CEO, said

“As we continue to see increasing demand for RUCONEST® in the treatment of hereditary angioedema, we are pleased to announce the approval of our new facility, which will enable us to significantly increase production capacity for supply to patients in the EU. In addition, as a result of our recent re-acquisition of RUCONEST®’s European distribution rights from Sobi, this capacity expansion will allow us to reach an even greater number of EU patients”.

tijd 10.28
Pharming EUR 1,455 +3,1ct vol. 3,9 miljoen.



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