Leiden, the Netherlands, March 28th, 2013. Biotech company Pharming Group NV ("Pharming") (NYSE Euronext: PHARM) announced today that it 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".
About Pharming Group NV
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. RUCONEST® is partnered with Santarus Inc (NASDAQ: SNTS) in North America where the drug has completed Phase III clinical development. The product is also being evaluated for various follow-on indications. Pharming has a unique GMP compliant, validated rabbit platform for the production of recombinant human proteins that, with the EU approval of Pharming's rhC1 inhibitor, has proven capable of producing industrial volumes of high quality recombinant human protein in a significantly more economical way through low upfront capital investment and manufacturing costs, compared to current cell based technologies. Pharming now plans to utilise this platform for the development of rhFVIII for the treatment of Haemophilia A.Additional information is available on the Pharming website, www.pharming.com (http://www.pharming.com/).
This press release contains forward looking statements that involve known and unknown risks, uncertainties and other factors, which may cause the actual results, performance or achievements of the Company to be materially different from the results, performance or achievements expressed or implied by these forward looking statements.
Contact
Sijmen de Vries, CEO: T: +31 71 524 7400
FTI Consulting: Julia Phillips/ John Dineen, T: +44 (0)207 269 7193
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Source: Pharming Group N.V. via Thomson Reuters ONE
