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.
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Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) announced today that it will propose Messrs. J. Ernst and A. de Winter as new members for its Supervisory Board at the upcoming Annual General Meeting of Shareholders on April 15, 2009.
Mr. Ernst (69), German citizen, has extensive senior level experience in the field of pharmaceutical development and marketing. From 1969 until 1989 he held several positions at Kali-Chemie (subsidiary of Solvay SA), including Head of Pharmaceutical Marketing and Head of Pharmaceutical Division. In 1980, Mr Ernst continued his career at Solvay and held several positions until he retired in 2004. Amongst other, he was member of the Board of Pharmaceutical Division, CEO of Health Divisions, Member of the Executive Committee, General Manager Pharmaceutical Sector and Supervisory Director and member of the Executive Committee. Mr. Ernst holds an ISMP Degree from Harvard University and a MBA from the University of Cologne (Germany).
Mr. de Winter (56), Dutch citizen, has extensive financial experience. He started his career at AMRO Bank in 1980. In 1990, Mr. de Winter became senior Advisor Corporate and Institutional Finance at NIBC (formerly 'De Nationale Investerings bank'). From 1998 till last year, as Director of Listing & Client Services and Director, he was responsible for several listing and issuer relations activities, including execution and placement of capital market transactions and new listings on the Amsterdam Stock Exchange. Mr. de Winter is currently Associate Partner of First Dutch Capital. He holds a Law Degree from Erasmus University, the Netherlands, specializing in corporate law.
The Annual General Meeting of Shareholders will be held on April 15, 2009 at 15:00 hrs CET at the offices of the Company in Leiden. The agenda with explanatory notes thereto (including data concerning the proposed new members of the Supervisory Board), proxy form, the Annual Report 2008 and route description are available for Shareholders at the offices of the Company as of today. Copies of these documents can be obtained free of charge and will also be available at the Company's website (www.pharming.com) as of today.
