Pharming Submits Request For Re-examination Of CHMP Opinion For European Marketing Authorization Application For Rhucin(R)
- Category: Proteins and Peptides
- Published on Sunday, 23 December 2007 00:46
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Biotech company Pharming Group NV 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 issued last week
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.
About Rhucin® and HAE
Rhucin® (recombinant human C1 esterase inhibitor) is a human protein developed through Pharming’s proprietary technology where the human protein is expressed 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.
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 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). 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.
SOURCE: Pharming Group NV