Pharming confirms positive results from final analysis of Rhucin®
studies>
Pharming confirms positive results from final analysis of Rhucin® studies
(Thomson Reuters ONE) - Leiden, The Netherlands, July 1, 2009. Biotech company PharmingGroup NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) todayannounced that, as part of the activities for the regulatorysubmission files, it has now also completed the final analysis of itsRhucin® randomised placebo-controlled studies. The results confirmthe positive and consistent efficacy and safety of Rhucin in thetreatment of acute angioedema attacks in patients with HereditaryAngioedema (HAE).Pharming conducted two independent, randomized, double blind, placebocontrolled clinical studies in Europe and in North-America (US andCanada). In total, 70 attacks were randomized to one of two doses ofRhucin (100 U/kg, 50 U/kg body weight) or placebo control treatment.Of these 70 patients, 32 were treated in the European study and 38patients in the North-American study. The final statistical analyseshave now been undertaken in line with the latest EU and US regulatoryguidance. Both studies independently demonstrated statisticallysignificant and clinically relevant results on primary and secondaryendpoints, thus demonstrating the efficacy of Rhucin for thetreatment of acute attacks of Hereditary Angioedema.In the EU study, time to onset of relief (median), the primaryendpoint, was 62 minutes for Rhucin 100 U/kg compared to 508 minutesfor control treatment. In the North America study, time to onset ofrelief (median) was 68 and 122 minutes respectively for Rhucin 100and 50 U/kg compared to 258 minutes for control treatment. In the EUstudy, time to minimal symptoms (median), the secondary endpoint, was480 minutes for Rhucin 100 U/kg compared to 1440 for controltreatment. In the North America study, time to minimal symptoms(median) was 245 and 247 minutes respectively for Rhucin 100 and 50U/kg compared to 1101 for control treatment. None of the Rhucintreated patients experienced a relapse of symptoms in the sameattack.As to safety, no clinically relevant concerns were reported in eitherstudy. There were no drug-related serious adverse events, no allergicreactions, and, no immuno-safety concerns due to antibody responsesto Rhucin or rabbit milk proteins. Rhucin infusions were welltolerated, without reports of pain or irritation at the injectionsite. Together with the evaluation of the open-label studies andother studies reported previously, the Rhucin safety database nowincludes over 300 treatments of acute attacks."The results from these studies demonstrate Rhucin's excellentefficacy and safety profile in treating acute attacks of HAE," saidMarco Cicardi, MD, Professor of Internal Medicine at the Universityof Milan, Italy and Principal Investigator of the European trial."Having a recombinant human C1 inhibitor protein, such as Rhucin, asa treatment option for HAE is a notable advance in the field thatwill be important to both patients and physicians.""Rhucin has shown to safely provide rapid and sustained relief ofsymptoms in HAE patients having acute attacks. We believe that ourcurrent clinical database adequately supports the efficacy and safetyof Rhucin, in single and repeated use, in acute attacks at allanatomical locations, including laryngeal attacks," said BrunoGiannetti, Chief Operations Officer of Pharming. "With the Europeanregulatory agency recently agreeing on the pediatric investigationplan for Rhucin in HAE and the recently reported immuno-safety data,we are on schedule to submit our European Union MarketingAuthorization Application for Rhucin in September 2009."The open-label extension studies of Rhucin are ongoing in HAEpatients for the treatment of acute attacks. Over 380 acuteangioedema attacks of all types in over 130 patients have now beentreated including many potentially life-threatening laryngealattacks. More than 25 HAE patients have been treated at least 4 timesand one HAE patient has been treated 25 times.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.This 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:Sijmen de Vries, Pharming Group NV, T: +31 (0)71 52 47 400Marjolein van Helmond, Pharming Group NV, T: +31 (0)71 52 47 431http://hugin.info/132866/R/1326202/312071.pdfThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
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