Pharming has received European Medicines Agency (EMA)\napproval of a Type II Variation for a new production facility for the Company\u2019s\nlead product, RUCONEST\u00ae. <\/p>\n\n\n\n
With the addition of this new facility, Pharming will\nsignificantly increase the production capacity of RUCONEST\u00ae as it becomes fully\noperational over the coming year. Pharming is now also able to release the\nproduct that was manufactured at the facility during the approval process for commercialization\nin the EU. As previously announced, Pharming had identified a potential risk of\nshort-term pressure on the supply of RUCONEST\u00ae for the European market due to\nincreasing demand for the product. With the approval of this new facility, the\nCompany believes the risk to supply is now greatly reduced. <\/p>\n\n\n\n
The new facility\u2019s post-approval supplement (PAS) for the\ndistribution of RUCONEST\u00ae in the US is still under review by the Food and Drug\nAdministration (FDA). Approval of the new facility for distribution in the US\nis expected in H1 2020. <\/p>\n\n\n\n
Sijmen de Vries, Chief Executive of Pharming, said: \u201cAs we continue to see increasing demand for RUCONEST\u00ae 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\u00ae\u2019s European distribution rights from Sobi, this capacity expansion will allow us to reach an even greater number of EU patients.\u201d<\/p>\n\n\n\n