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

Highlights: New production site for starting material will significantly increase production capacity of RUCONEST® Product manufactured with material from the new site during the approval process is now also immediately available for distribution within the USA. Leiden, The Netherlands, 9 March 2020: Pharming Group N.V. (Euronext Amsterdam: PHARM) today announced it has also received US Food and Drug Administration (FDA) approval of Pharming’s Prior Approval Supplement to add the new Netherlands production facility of starting material to the Biologics License Application (BLA) to support its lead product, RUCONEST®. With the addition of this new facility for US supplies as well, Pharming can continue to expand sales in all markets in the coming year. Pharming is now also able to release the product that is manufactured with starting material from the facility for commercialisation in the USA. As previously announced, Pharming had already received approval for output from the new facility from the European Medicines Agency for commercial use in the European Union. Sijmen de Vries, Chief Executive of Pharming, said: “We are pleased to announce this approval by the FDA of our new facility, which will enable us to meet increasing demand for RUCONEST® in the treatment of hereditary angioedema for patients in the USA as well as for those in the EU. Following on from the EMA approval announced earlier this year in January, this gives us sufficient capacity for current demands as we continue to build for the future. “ Resources For further information, please contact: Media Relations Investor Relations Quick links

The release as fetched from its publisher. pharming.com ↗