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Pharming Gets Euro-GMP

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Pharming Group’s facilities for the manufacture of Rhucin have passed all EMEA inspections, establishing GMP compliance for pharmaceutical production. The EMEA has confirmed that all facilities and processes involved in the manufacture of Rhucin, Pharming’s lead product, operate according to GMP standards. These include facilities for transgenic rabbits, the external facilities where milk and product are processed, and the company’s headquarters in Leiden, in relation with quality aspects of Rhucin.

Dr. Bruno Giannetti, chief operations officer at Pharming, said, “Obtaining GMP status for our facilities and processes is a major achievement for our company. It is a critical step in the review and approval process of Rhucin and it is difficult to overestimate the importance of achieving this milestone. It is testimony to the hard and excellent work that our team has put in to convert a research idea of ‘turning milk into medicine’ into a well-developed and GMP-approved manufacturing process. Our transgenic rabbit facility is the first of its kind in the world to obtain this status.”

Pharming has filed a marketing authorization application for Rhucin in Europe and expects to hear from the scientific committee of the EMEA in the second half of 2007. In the U.S., Pharming plans to finalize its clinical trial in the second half of 2007. The company will present results from the clinical trials of Rhucin for the treatment of HAE in 3Q2007.

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