Pharming's Marketing Authorisation Application for Rhucin validated
by the European Medicines Agency
(Thomson Reuters ONE) - Evaluation procedure has started todayLeiden, The Netherlands, September 23, 2009. Biotech companyPharming Group NV ("Pharming" or "the Company") (NYSE Euronext:PHARM) today received confirmation of validation from EMEA of itsMarketing Authorization Application (MAA) for Rhucin®. This meansthat the formal scientific evaluation procedure of the EuropeanMedicines Agency (EMEA) has started today.Pharming submitted the MAA for Rhucin to EMEA earlier this month.Today, the EMEA notified the Company that it has completed thevalidation of the dossier. As result of this, the CentralizedProcedure for scientific evaluation of the MAA by the Committee forMedicinal Products for Human Use (CHMP) has started today. Accordingto the standard timetable of the Centralized Procedure, the CHMPadopts a List of Questions at Day 120. This List of Questions isbased on the Day 80 Assessment Report from the Rapporteur andCo-Rapporteur. The Company should submit its responses to thesequestions within 3 months, after which the 'clock' will restart andthe procedure will be continued. Pharming may expect the adoption ofthe final CHMP opinion within a total of 210 days review time(excluding any clock-stops).. More information on this procedure canbe found on www.emea.europa.eu.About Rhucin® and HAERhucin® (recombinant human C1 esterase inhibitor) is a human proteindeveloped through Pharming's proprietary technology where the humanprotein is expressed in milk of transgenic rabbits. |Pharming isdeveloping its recombinant human C1 inhibitor for treatment ofpatients with acute attacks of Hereditary Angioedema (HAE). HAE is ahuman genetic disorder caused by a shortage of C1 inhibitor activityand results in an overreaction of the immune system. The disease ischaracterized by acute attacks of painful and in some cases fatalswelling of several soft tissues (edema), which may last up to fivedays when untreated. In addition to the life-threatening nature ofthe disease, quality of life for individuals with the disease may beseriously impaired. Approximately one in 30,000 individuals suffersfrom HAE and has an average of seven acute attacks per year.About Pharming Group NVPharming Group NV is developing innovative products for the treatmentof genetic disorders, ageing diseases, specialty products forsurgical indications, intermediates for various applications andnutritional products. Pharming has two products in late stagedevelopment - Rhucin® for Hereditary Angioedema and human Lactoferrinfor use in food products and one product in early stage clinicaldevelopment - Prodarsan® for Cockayne Syndrome. The advancedtechnologies of the Company include innovative platforms for theproduction of protein therapeutics, technology and processes for thepurification and formulation of these products, as well as technologyin the field of DNA repair (via DNage). Additional information isavailable on the Pharming website, http://www.pharming.com.List of used abbreviationsCHMP - Committee for Medicinal Products for Human UseEMEA - European Medicines AgencyHAE - Hereditary AngioedemaMAA - Market Authorization ApplicationRhucin - Recombinant human C1 inhibitor for treatment of acute HAEattacksThis press release contains forward looking statements that involveknown and unknown risks, uncertainties and other factors, which maycause the actual results, performance or achievements of the Companyto be materially different from the results, performance orachievements expressed or implied by these forward lookingstatements.Contact:Ms. Marjolein van Helmond, Pharming Group NV, T: +31 (0)71 52 47 431or +31 (0)6 109 299 54http://hugin.info/132866/R/1343311/321760.pdfThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 23.09.2009 - 23:25 Uhr
Sprache: Deutsch
News-ID 6151
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