LEIDEN, NETHERLANDS -- (MARKET WIRE) -- 07/11/08 --
Leiden, The Netherlands, July 11, 2008. Biotech company PharmingGroup NV ("Pharming" or "the Company") (NYSE Euronext: PHARM)announced today positive results from ongoing open-label studies withrecombinant human C1 inhibitor (Rhucin®) for the treatment of acuteattacks of Hereditary Angioedema (HAE).
The positive results are from the treatment of 123 acute HAE attacksin 64 patients with different doses of Rhucin® in the ongoingEuropean and North American open-label studies. Rhucin® has beenconsistently safe and effective in patients receiving up to ninetreatments with no evidence of decreased response to the study drug.Importantly, all seven serious laryngeal attacks treated in thesestudies responded rapidly to Rhucin®. The open-label data areconsistent with findings from Pharming's two randomized,double-blind, placebo-controlled studies of Rhucin® with a mediantime to onset of relief of one hour and a median time to minimalsymptoms of four hours.
Dr. Bruno Giannetti, Chief Operations Officer at Pharming, commented:"We are very pleased with these positive results with Rhucin®. Theyconfirm the clinical benefits of Rhucin®, also in repeat treatment,without showing any adverse reactions or immune responses.Furthermore, the total number of treatments has substantiallyincreased, including the successful treatment of serious potentiallylife-threatening laryngeal attacks. We very much appreciate thesupport of the investigators and patients with HAE with theseclinical trials. These studies are important contribution to makingRhucin® available for HAE patients worldwide."
The results from open-label studies confirm Rhucin® to be safe andeffective in the repeat treatment of acute HAE attacks at differentdosage regimens. No clinically relevant adverse reactions werereported from these studies. The open-label treatments represent asubstantial increase to the Rhucin® clinical database and will beused to support planned regulatory submissions.
About Rhucin® and HAE
Rhucin® (recombinant human C1 esterase inhibitor) is a human proteindeveloped through Pharming's proprietary technology where the humanprotein is expressed in milk of transgenic rabbits. Rhucin® iscurrently under development for treatment of patients with acuteattacks of Hereditary Angioedema (HAE). HAE is a human geneticdisorder caused by a shortage of C1 inhibitor activity and results inan overreaction of the immune system. The disease is characterized byacute attacks of painful and in some cases fatal swelling of severalsoft tissues (edema), which may last up to five days when untreated.
About Pharming Group NV
Pharming 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. The advanced technologies of the Companyinclude innovative platforms for the production of proteintherapeutics, technology and processes for the purification andformulation of these products, as well as technology in the field ofDNA repair (via DNage). Additional information is available on thePharming website, http://www.pharming.com and on http://www.dnage.nl.
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:
Carina Hamaker, Investor Voice T: +31 (0)6 537 499 59 or T: +31 (0)7152 47 400Julia Philips (UK), Financial Dynamics, T: +44 (0)20 7269 7187 or T:+44 (0)7770 827 263Samir Singh (US), Pharming Group NV, T: +1 908 720 6224Rein Strijker, Pharming Group NV, T: +31 (0)71 52 47 400
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