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Pharming Group N.V. (PINKSHEETS: PHGUF) Company to move forward with regulatory filings
Leiden, The Netherlands, June 16, 2008. Biotech company Pharming Group N.V. ("Pharming" or "the Company") (NYSE Euronext: PHARM) announced today positive safety and efficacy results from its North American trial with Rhucin® (recombinant human C1 inhibitor) for the acute treatment of Hereditary Angioedema (HAE). The positive results with both primary and secondary endpoints of study allow Pharming to move forward with regulatory filings for Rhucin®.
The randomized double-blind placebo-controlled study with Rhucin® was conducted at several sites in the US and Canada. On having an acute HAE attack, 39 patients were randomized to one of two doses of Rhucin® (100 U/kg, 50 U/kg) or placebo. For the primary endpoint, the intent-to-treat analysis demonstrates that patients who received the 100 U/kg dose of Rhucin® reported median first symptom relief at approximately 68 minutes, those that received the 50 U/kg dose reported relief at approximately 100 minutes, and those that received placebo reported symptom relief at approximately 258 minutes. The time to minimal clinical symptoms, the secondary endpoint, was reported by patients in the 100 U/kg, 50 U/kg, placebo groups as approximately 245, 247, and 1098 minutes, respectively. The primary and secondary endpoint results with both doses of Rhucin® were clinically meaningful and statistically significant relative to placebo with p-values < 0.01. There was no statistically significant difference observed between patients treated with 100 U/kg or 50 U/kg dose of Rhucin®.
The North American randomized results with Rhucin® are in line with the positive results from the European randomized placebo-controlled Phase III clinical trial reported previously. The safety experience from the trial indicates that Rhucin® continues to be very well tolerated and no relevant, treatment-related adverse events were reported in any of the three treatment groups. Preliminary data from the ongoing open-label phase of the study, including treatment of over 100 attacks, further demonstrates that Rhucin® is safe and effective when treating patients for HAE attacks on a repeated basis. Data on treating repeat attacks represents an important addition to the database and will strengthen upcoming filings. The full results of the open label studies in the US and EU will be reported separately.
"Rhucin® is the only recombinant human C1 inhibitor product in development for HAE patients and has now unequivocally demonstrated fast acting efficacy in two independent randomized controlled trials," said Bruno Giannetti MD, PhD, Chief Operations Officer of Pharming. "The safety profile of the recombinant product is also excellent and has been confirmed in several clinical trials involving over 100 subjects with over 200 infusions. We wish to thank all the patients as well as investigators for their support in these trials and look forward to providing them a much needed treatment."
"The results from the US study demonstrate Rhucin®'s excellent efficacy and safety profile in treating acute attacks of HAE," said Bruce Zuraw, MD, Professor of Medicine at the University of California San Diego and Principal Investigator of the North American trial. "Having a recombinant human C1 inhibitor protein, such as Rhucin®, as a treatment option for HAE is a notable advance in the field that will be important to both patients and physicians."
Based on these results, Pharming intends to file regulatory submissions for Rhucin® in several early launch markets in the second half of 2008 and will meet with EMEA and FDA to accelerate regulatory filings in Europe and the USA.
About Pharming Group NV Pharming Group NV is developing innovative products for the treatment of genetic disorders, aging 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 and human lactoferrin for use in food products. 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 DNage BV). Additional information is available on the Pharming website, http://www.pharming.com and on http://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.
Contact:
Carina Hamaker, Investor Voice T: +31 (0)6 537 499 59 or T: +31 (0)71 52 47 400 Julia Philips (UK), Financial Dynamics, T: +44 (0)20 7269 7187 or T: +44 (0)7770 827 263 Samir Singh (US), Pharming Group NV, T: +1 908 720 6224 Rein Strijker, Pharming Group NV, T: +31 (0)71 52 47 400
