Pharming Group N.V.
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Publicatie datum
20 aug 2007 - 13:51
Statutaire naam
Pharming Group N.V.
Titel
Pharming Reports Positive Results In European Placebo-controlled Trial Of Rhucin® In Hereditary Angioedema
Bericht
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.
Datum laatste update: 16 december 2025