Pharming Facilities Obtain GMP Status
Important progress in European approval process of Rhucin®
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.
Rhucin® (recombinant human C1 esterase inhibitor) is a human protein developed through Pharming’s proprietary technology in milk of transgenic rabbits. Rhucin® is currently under development to treat acute attacks of Hereditary Angioedema (HAE), a disease characterized by painful swelling of soft tissue. The disease is caused by a shortage of functional C1 esterase inhibitor in patients and results in an overreaction of the immune system.
About Pharming Group NV
Pharming Group NV is developing innovative products for the treatment of genetic disorders, specialty products for surgical indications, intermediates for various applications and food products. Pharming has two products in late stage development - recombinant human C1 inhibitor for hereditary angioedema (MAA submitted to EMEA) and human lactoferrin for use in functional foods (GRAS notification filed with FDA). The advanced technologies of the Company include innovative platforms for the production of protein therapeutics, technology and processes for the purification and formulation of these products, as well as technologies in the field of tissue repair (via its collaboration with Novathera) and DNA-repair (via its acquisition of DNage BV). Additional information is available on the Pharming website, http://www.pharming.com and on http://www.dnage.nl
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. The press release also appears in Dutch. In the event of any inconsistency, the English version will prevail over the Dutch version.
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- Rein Strijker
- Pharming Group NV
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