Pharming Submits Marketing Authorisation Application For Recombinant Human C1 Inhibitor In Europe
Leiden, The Netherlands, July 21, 2006. Biotech company Pharming Group N.V. (“Pharming” or “the Company”) (Euronext: PHARM) (PHARM.AS) announced today it has submitted the Marketing Authorization Application (MAA) for recombinant human C1 inhibitor (rhC1INH) to the European Medicines Agency (EMEA) for the treatment of acute attacks of hereditary angioedema (HAE).
Hereditary angioedema (HAE) is a human genetic disorder caused by a shortage of C1 inhibitor activity. Approximately one in 30,000 individuals suffers from HAE and has an average of seven acute attacks per year. HAE attacks that are untreated usually last up to five days. The disease is characterized by acute attacks of painful swelling of soft tissues (edema), including regions of the skin, the intestine, and the mouth and throat. If the soft tissue of the throat is involved, an attack of angioedema can be fatal. In addition to the life-threatening nature of the disease, quality of life for individuals with the disease may be seriously impaired.
The MAA is supported by clinical and pharmaceutical data on rhC1INH as required by the EMEA. In clinical studies, all HAE patients treated with rhC1INH 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 rhC1INH’s safety and effectiveness with rapid and sustained relief for patients with acute attacks of HAE.
The rhC1INH product has already received Orphan Medicinal Product Designation for HAE in Europe, which provides ten years of market exclusivity for an approved recombinant human C1 inhibitor product. The Company expects to provide further information on rhC1INH at an appropriate time and in a manner which reflects the ongoing interactions with EMEA for approval of the product.
Pharming’s rhC1INH could represent the first new therapy for HAE patients in over 30 years if approved. The only approved product for the treatment of HAE attacks is plasma derived C1 inhibitor, which is available in a limited number of European countries.
“The MAA submission is a significant milestone in the development of rhC1INH and demonstrates our commitment to provide a highly effective therapy for patients living with the burden of hereditary angioedema,” said Dr. Francis Pinto, CEO of Pharming. “For Pharming, the rhC1INH submission represents a major leap forward in its evolution as a product-focused biotech company addressing unmet medical needs.”
Pharming has secured the large scale commercial production of rhC1INH through its collaboration with the Akzo Nobel subsidiary Diosynth B.V. Based on the standard schedule for accepted applications using the centralized procedure, Pharming anticipates responding to questions from EMEA and coordinating inspections in 2006. Further information on EMEA procedures can be found on: http://www.emea.eu.int.
Background on Pharming Group N.V.
Pharming Group N.V. is developing innovative protein products for unmet needs. The Company’s products include potential treatments for genetic disorders, specialty products for surgical indications, intermediates for various applications and food products. Pharming has two products in late stage development - recombinant human C1 inhibitor for hereditary angioedema (MAA submitted to EMEA) and human lactoferrin for use in functional foods (GRAS notification filed with 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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