Pharming Reports Positive Results in European Placebo-Controlled Trial of Rhucin in Hereditary Angioedema
Independent Data Monitoring Committee Advises Pharming to Stop Placebo Arm on Ethical Grounds
LEIDEN, The Netherlands, August 20, 2007. Biotech company Pharming Group N.V. ("Pharming" or "the Company") (Euronext: PHARM) announced today that it has completed an interim analysis of its European randomized placebo-controlled double-blind clinical study designed to evaluate efficacy and safety of Rhucin® in the treatment of acute attacks of Hereditary Angieoedema ("HAE"). The analysis complements the earlier publication of results of an open label study which showed strong positive effects of Rhucin®. None of the patients receiving Rhucin® showed a relapse of their attack, nor any treatment-related adverse events during this study, confirming the safety profile of the product as was determined in earlier studies. Details of the clinical results will be presented on August 30th at a meeting in London to analysts and press (see details below).
Based on the results and after consulting with the Independent Data Monitoring Committee the Company has decided to discontinue further randomized treatments within the clinical study for methodological and ethical reasons. All investigators have been informed. All involved Ethics Committees and Regulatory Authorities have received or will shortly be receiving appropriate filings.
Pharming has included the analysis in its dossier submitted to the European Medicines Evaluation Agency ("EMEA") to further support its request for Marketing Authorization in Europe. Data from the analysis were also submitted to the FDA in the USA where an independent placebo-controlled randomized clinical study assessing the safety and efficacy of Rhucin® is expected to be completed in the next few months.
Dr. Bruno Giannetti, Chief Operations Officer of Pharming, commented: "We are extremely pleased with the outcome of this analysis. The data confirm the results obtained earlier in open label studies and show that Rhucin® is a very fast acting product that could be of great therapeutic benefit for patients with HAE. The product has an excellent safety profile based on the results of various studies in which, in total, well over 100 infusions were given to subjects. Importantly, no relapses of any of the attacks occurred. The Company has filed an amendment to stop further randomized treatments, whereas open label treatment of acute attacks with Rhucin® remains possible to allow patients in Europe and elsewhere to get access to and continue to benefit from this treatment.
A meeting for analysts and press will be held at the offices of Financial Dynamics in London on August 30th to discuss clinical results. Please contact Mo Noonan or Claire Rowell at FD on +44 20 7269 7116 for full details.
About Rhucin® and HAE 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 for treatment of patients with acute attacks of hereditary angioedema ("HAE"). HAE is a human genetic disorder caused by a shortage of C1 inhibitor activity and resulting in episodes of edema. The disease is characterized by acute attacks of painful and in some cases fatal swelling of several soft tissues (edema), which may last up to five days when untreated. In the Western world, approximately 1 in 30,000 individuals suffers from hereditary angioedema, having an average of seven acute attacks per year.
About Pharming Group N.V. 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.
Anne Louise van Julia Philips Rein Strijker Lynden Investor Voice Financial Dynamics Pharming Group N.V. T: +31 (0)654315549 T: +44 (0)20 7269 T: +31 71 7187 524742434 T: +31 (0)71 524 7431 T: +44 (0)7747 602 739
Posted: August 2007