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Pharming Group N.V. (AMS:PHARM) Database for Rhucin® Significantly Expanded
Leiden, The Netherlands, September 22, 2008. Biotech company Pharming Group NV ("Pharming" or "The Company") (Euronext: PHARM) today announced that Dr. Francis J. Pinto, CEO will provide a business update during the UBS Global Life Sciences Conference in New York City.
During the presentation of Dr. Pinto, which will be available on Pharming's website, data will be shown that illustrate the marked progress made over the last few months in the development of its late stage product, Rhucin®. In particular, much focus was given on the analysis of patients receiving repeat treatments of Rhucin® and patients suffering from severe attacks which were of concern to regulatory authorities earlier this year.
In the data presented, Pharming has shown that over 300 administrations of Rhucin® have now been analyzed, with more than half in repeat treatments. One patient received 12 administrations so far. There was no sign of any relevant safety issues in these repeat treatments and the efficacy remains excellent. The database on very severe attacks has also been expanded to include now seven laryngeal attacks, which have all been successfully treated with Rhucin®. In all treatments performed with Rhucin® in patients so far, no allergic reaction has been observed.
Pharming believes that it has successfully addressed the concerns raised by Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA). In its opinion in March 2008, the CHMP requested a larger clinical database to ensure the safety and efficacy of the product upon repeat use. The committee also paid attention to potential allergic reactions and the risk/benefit ratio in severe attacks (especially of the larynx).
Dr Francis J. Pinto, Chief Executive Officer, commented: "We are very excited about the progress made over the last few months in our Rhucin® program. The database is now much stronger and larger than at the time of our initial filing at the EMEA about two years ago. In particular we have been able to address the issues raised by the European Authorities in a very promising way thereby generating data that confirm the effectiveness and safety of Rhucin® in repeat use. We are convinced that we now have an improved and very strong data package supporting the upcoming registration files. We are in discussions with the relevant authorities regarding the submission of our data packages which we hope to complete as soon as practically possible."
Pharming is planning to submit the Biological License Application (BLA) for Rhucin® with the US Food and Drug Administration (FDA) by the end of the year. The Company expects to follow the BLA filing with its Market Authorization Application for Rhucin® to EMEA shortly thereafter.
About Pharming Group NV Pharming Group NV is developing innovative products for the treatment of genetic disorders, ageing diseases, specialty products for surgical indications, intermediates for various applications and nutritional products. Pharming has two products in late stage development - Rhucin® for Hereditary Angioedema and human lactoferrin for use in food products. 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 technology in the field of DNA repair (via DNage). 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.
Contact:
Carina Hamaker, Investor Voice, T: +31 (0)6 537 499 59 or T: +31 (0)71 52 47 400 Julia Philips (UK), Financial Dynamics, T: +44 (0)20 7269 7187 or T: +44 (0)7770 827 263 Samir Singh (US), Pharming Group NV, T: +1 908 720 6224 Rein Strijker, Pharming Group NV, T: +31 (0)71 52 47 400
