Biotech company Pharming Group NV (Pharming) has received approval from the European Medicines Agency (EMA) for Sanofi Chimie to manufacture drug substance for Pharming’s product Ruconest at their Aramon (France) site. Sanofi Chimie is acting as Pharming’s Contract Manufacturing Organization.

Sanofi Chimie’s Aramon site is recognized for its industrial excellence in the production of biologics. The site reaches high quality standards and its team has a very good track record with health authorities.

The approval of the production site by EMA (European Medicines Agency), which was achieved through a Type II variation, allows Pharming to supply the European market with drug substance from Sanofi Chimie.

Pharming’s ability to leverage the manufacturing process for Ruconest, a recombinant human C1 inhibitor approved for the treatment of angioedema attacks in patients with HAE (Hereditary Angioedema), represents a significant competitive advantage over manufacturers of plasma- (blood) derived products, which are dependent on blood donations.

The Contract Manufacturing process requires a highly complex purification process. Three different chromatography steps are necessary to obtain a robust high quality profile of drug substance. All essential sophisticated analytical methods involved have been also successfully implemented and validated.

This approval will enable significant improvements in Ruconest’s competitiveness and will allow Pharming to meet future global demands with a secure supply chain agreement on the long term for the treatment of HAE as well as follow-up indications.

Bruno Giannetti, COO of Pharming, said: "The approval from the EMA to manufacture Ruconest at the Sanofi Aramon (France) site is an important development for Pharming as it will allow us to scale up manufacturing of Ruconest ahead of future market demand, particularly as we progress towards US approval of Ruconest with our partner, Santarus. Importantly, this approval significantly enhances Ruconest’s competitive profile, as it enables us to ramp-up manufacturing of Ruconest and optimizing the cost of goods for the product”.

Pharming Group NV is developing innovative products for the treatment of unmet medical needs. Ruconest is a recombinant human C1 inhibitor approved for the treatment of angioedema attacks in patients with HAE in all 27 EU countries plus Norway, Iceland and Liechtenstein, and is distributed in the EU by Swedish Orphan Biovitrum.