Leiden, The Netherlands, March 31, 2009. Biotech company Pharming Group NV (“Pharming” or “the Company”) (NYSE Euronext: PHARM) today announces that, in agreement with the European Medicines Agency (EMEA), the dossier for the European Marketing Authorisation Application (MAA) of Rhucin® will be submitted in September 2009.
Pharming has been in continuous dialogue with the EMEA and FDA (US Food and Drug Administration) regarding the Rhucin development program and the requirements needed to support regulatory submissions. As a result, the Company is implementing additional data analyses requested by EU and US regulatory authorities. Based on recent feedback from the FDA, Pharming is preparing its Biologic License Application (BLA) for Rhucin and will request a pre-BLA meeting in the second half of 2009.
To date, 150 HAE (Hereditary Angioedema) patients have received a total of 334 therapeutic doses of Rhucin to treat acute angioedema attacks. 179 repeat doses have been administered to treat acute HAE attacks in 83 patients. The Company considers that the current clinical database adequately supports the efficacy of Rhucin, following single and repeated use, to treat all types of acute attacks including laryngeal attacks. There has been consistent efficacy on repeated use. There have been no clinically relevant safety concerns and no confirmed allergic reaction following the treatment of acute HAE attacks with Rhucin. Pharming will continue open-label clinical studies to maintain the availability of Rhucin to HAE patients for the treatment of acute attacks.
“We are very pleased with the progress to prepare our submissions for Rhucin. We are working hard on the challenge to align the European and US filings so as to be able to file the BLA with the FDA as soon as possible after the European submission,” said Dr. Bruno Giannetti, Chief Operations Officer of Pharming. “We believe that the EU MAA submission should address all the clinical issues that remained after last year’s CHMP opinion. Our goal is to bring Rhucin to as many markets and as many HAE patients as soon as feasible.”
The Company is also preparing filings for Rhucin in countries outside the USA and the European Union. These activities may, from time to time, require new clinical studies. These studies will not affect the timing of the submission of the Rhucin dossier to the EMEA and FDA.
