Pharming Group N.V.
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Publicatie datum
13 jul 2007 - 07:33
Statutaire naam
Pharming Group N.V.
Titel
Pharming facilities obtain GMP status
Bericht
Leiden, The Netherlands, July 13, 2007. Biotech company Pharming Group NV (“Pharming” or “the Company”) (Euronext: PHARM) announced today that its facilities for the manufacturing of Rhucin® have successfully passed all inspections conducted by the European Medicines Evaluation Agency (“EMEA”) establishing that they comply to the standards of Good Manufacturing Practice (“GMP”) for pharmaceutical production.
The EMEA has confirmed that all facilities and processes that are involved in the manufacturing of Rhucin®, Pharming’s lead product, operate according to GMP standards. These facilities include Pharming’s facilities for transgenic rabbits, the external facilities where milk and product are stored and processed and the Company’s headquarters in Leiden as far as it is concerned with quality aspects of Rhucin®.
Dr. Bruno Giannetti, Chief Operations Officer at Pharming, commented: “Obtaining the 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 has recently submitted answers to the list of questions from the EMEA. Based on the timelines associated with the review of this product, Pharming expects an opinion of the scientific committee of the EMEA in the second half of 2007. In the USA, Pharming aims to finalize its placebo-controlled randomized 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 the third quarter of 2007.
About Rhuci
Datum laatste update: 18 januari 2025