Pharming Group N.V.
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Publicatie datum
21 dec 2007 - 12:12
Statutaire naam
Pharming Group N.V.
Titel
PHARMING SUBMITS REQUEST FOR RE-EXAMINATION OF CHMP OPINION FOR EUROPEAN MARKETING AUTHORIZATION APPLICATION FOR RHUCIN®
Bericht
Leiden, The Netherlands, December 21, 2007. Biotech company Pharming Group NV (“Pharming”) (NYSE Euronext: PHARM) announced today that, in accordance with European regulations No 726/2004, it has given written notice to the European Medicines Agency (EMEA) for re-examination of the opinion of the CHMP (Committee for Medicinal Products for Human Use) issued last week.
The re-examination is part of the formal marketing authorization procedure, which still needs to be completed. Pharming believes that the findings of clinical studies have demonstrated clear evidence of Rhucin®’s efficacy and safety in treatment of acute HAE attacks. In a randomized placebo-controlled study Rhucin® showed statistically significant superiority over placebo in time to first relief of the attack and in time to minimal symptoms. These results have been accepted by the CHMP. No patient experienced a relapse of the HAE-attack or any treatment-related adverse event. Pharming is, therefore, convinced that the available data submitted to the CHMP demonstrate that Rhucin® is safe and efficacious in treatment of acute HAE attacks and provide a sound basis for granting a marketing authorisation for Rhucin® in the European Union.
With respect to the other elements of its business Pharming confirms that its plans have not changed and have not been impacted by the initial opinion of the CHMP. The Company is backed by a sound financial position allowing the further development of its business for several years leading to product approvals, partnerships and other major advances in its portfolio.
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