Pharming’s Marketing Authorization Application For Rhucin® (rhC1INH) Accepted For Review By EMEA
Leiden, The Netherlands, August 17, 2006. Biotech company Pharming Group N.V. (“Pharming”) (Euronext: PHARM) (PHARM.AS) announced today that its Marketing Authorization Application (MAA) for recombinant human C1 inhibitor (rhC1INH or Rhucin®) for treatment of acute attacks of hereditary angioedema (HAE) has been accepted for review by the European Medicines Agency (EMEA). The Company further announced that it has selected Rhucin® as the global trade mark for rhC1INH for the treatment of acute HAE attacks.
The review of Pharming’s MAA for Rhucin® by EMEA will follow the centralized marketing authorization procedure. If approved, Rhucin® will receive marketing authorization in all 25 EU member states. Based on the standard schedule for accepted applications using the centralized procedure, Pharming anticipates that EMEA’s initial response and questions concerning the application for Rhucin® will come later this year. Further information on EMEA procedures can be found at www.emea.eu.int.
The MAA is supported by clinical and pharmaceutical data on Rhucin® as required by the EMEA. In clinical studies, all HAE patients treated with Rhucin® demonstrate a rapid time to beginning of relief (typically less than 2 hrs) and time to minimal symptoms (typically less than 12 hrs). The data from preclinical and clinical studies reinforce the safety and effectiveness of Rhucin® with rapid and sustained relief for patients with acute attacks of HAE.
If approved, Rhucin® will represent the first new therapy for HAE patients in over thirty years. The only other approved product for the treatment of HAE attacks is plasma derived human C1 inhibitor, which is available in a limited number of European countries.
Rhucin® (recombinant human C1 inhibitor) is being developed 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. The disease is characterized by acute attacks of painful and in some cases fatal swelling of several soft tissues (edema), which usually 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.
Background on Pharming Group NV
Pharming Group NV is developing innovative protein products for the treatment of genetic disorders, specialty products for surgical indications, intermediates for various applications and food products. Pharming has two products in late stage development - Rhucin® (recombinant human C1 inhibitor) for hereditary angioedema (under review by EMEA) and human lactoferrin for use in functional foods (GRAS notification under review by US FDA). The advanced technologies of the Company include innovative platforms for the production of protein therapeutics, as well as technology and processes for the purification and formulation of these products. Additional information is available on the Pharming website, http://www.pharming.com.
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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- Samir Singh
- Pharming Group NV
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