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Aandeel Pharming Group AEX:PHARM.NL, NL0010391025

Laatste koers (eur) 0,909 25 apr 2024 09:00

Verschil +0,005 (+0,50%) Dagrange 0,909 - 0,910

Volume 13.381 Gem. (3M) 6,9M

ki 29 oktober 2007 12:34

Leiden, The Netherlands, October 29, 2007. Biotech company Pharming Group N.V. (“Pharming” or “the Company”) (NYSE Euronext: PHARM) announced today that it has completed randomized treatments in its North American clinical trial assessing the safety and efficacy of Rhucin® (recombinant human C1 inhibitor) to treat acute attacks of hereditary angioedema (HAE). The Company plans to continue an open label study with Rhucin® for hereditary angioedema patients at sites across the United States and Canada.

In the study, 39 patients with acute attacks of HAE were treated with either Rhucin® (100U/kg or 50U/kg) or placebo. In the follow-up, patients with acute attacks of HAE were eligible to receive open label treatments with the product. The site of attacks treated in HAE patients included laryngeal, facial, abdominal, urogenital and peripheral. In total, 55 acute attacks of HAE were treated.

While the results of the placebo-controlled trial will be analyzed and announced after the completion of the follow up of the last patient later this quarter, the results of the open-label treatments were positive and in line with earlier published data. All patients responded favourably to the treatment and no relapses or treatment-related adverse events were recorded.

Recently, Pharming announced positive safety and efficacy results of Rhucin® from a randomized clinical trial conducted in Europe. The primary and secondary endpoints of the study demonstrated statistical and clinical significance. None of the patients receiving Rhucin® showed a relapse of the HAE attack or any treatment related adverse events, confirming the safety and efficacy profile of the product.

Pharming has filed a Marketing Authorization Application for Rhucin® with the European Medicines Agency (EMEA). Based on EMEA timelines, Pharming expects an opinion of the scientific committee of the EMEA later this year. The EMEA has already confirmed that all facilities and processes involved in the manufacturing of Rhucin® operate in accordance with Good Manufacturing Practice (GMP) standards.

Pharming will present topline results from the North American randomized clinical trial later this year. The Company expects to file a Biologics License Application with the U.S. Food and Drug Administration (FDA) shortly thereafter. Pharming has orphan drug and fast track designations on recombinant human C1 inhibitor for treatment of HAE from the FDA.

Dr. Bruno Giannetti, Chief Operations Officer of Pharming, commented, “The use of Rhucin® offers significant benefits for HAE patients as the product addresses the underlying genetic deficiency of the disease and is produced using a controlled recombinant system. Our European data derived from a placebo-controlled study combined with open-label data, obtained in Europe and North America, are very positive and show that the product is safe and provides fast relief for patients suffering attacks from this severe disease. We look forward to presenting topline results of the North American study and initiating our filings to also address the unmet medical need for HAE patients in North America.”

About Rhucin® and HAE
Rhucin® (recombinant human C1 esterase inhibitor) is a human protein developed through Pharming’s proprietary technology in milk of transgenic rabbits. Rhucin® is currently under development for treatment of patients with acute attacks of hereditary angioedema (“HAE”). HAE is a human genetic disorder caused by a shortage of C1 inhibitor activity and results in an overreaction of the immune system. The disease is characterized by acute attacks of painful and in some cases fatal swelling of several soft tissues (edema), which may last up to five days when untreated. In the Western world, approximately 1 in 30,000 individuals suffers from hereditary angioedema, having an average of seven acute attacks per year.

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® (recombinant human C1 inhibitor) for hereditary angioedema (MAA under review by EMEA) and human lactoferrin for use in food products (GRAS notification under review by FDA). 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 technologies in the field of tissue repair (via its collaboration with Novathera) and DNA repair (via its acquisition of DNage). Additional information is available on the Pharming website, www.pharming.com and on www.dnage.nl.

This press release contains forward looking statements that involve known and unknown risks, uncertainties and other factors, which may cause the actual results, performance or achievements of the Company to be materially different from the results, performance or achievements expressed or implied by these forward looking statements. The press release also appears in Dutch. In the event of any inconsistency, the English version will prevail over the Dutch version.

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