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Pharming Confirms Rhucin European MAA Filing Timeline
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Tuesday, March 31, 2009
Leiden, The Netherlands. 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(R) 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.
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(R) for Hereditary Angioedema and human Lactoferrin for use in food products and one product in early stage clinical development - Prodarsan(R) for Cockayne Syndrome. 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.
List of used abbreviations
BLA Biologic License Application CHMP Committee for Medicinal Products for Human Use EMEA European Medicines Agency FDA US Food and Drug Administration HAE Hereditary Angioedema MAA Market Authorization Application Rhucin Recombinant human C1 inhibitor for treatment of acute HAE attacks
Contact:
Sijmen de Vries, Pharming Group NV, T: +31 (0)71 52 47 400
Source: Pharming Group NV
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