Pharming Group N.V. 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 first half of 2020.