Pharming Group N.V. (Euronext: PHARM; “Pharming” or “the Company”) announced today that it has initiated the pivotal Phase III clinical trial for recombinant human C1 inhibitor (“rhC1INH”) for Hereditary Angioedema (HAE) in Europe. In its Phase III clinical trial, Pharming will assess the efficacy and safety of rhC1INH for the treatment of Hereditary Angioedema. The Company has received approval from appropriate regulatory authorities for the Phase III clinical trial with rhC1INH. The clinical protocol involves a double blind, randomized, placebo controlled trial for rhC1INH in HAE patients to be conducted at multiple centers across Europe. “We are excited to initiate our pivotal clinical trial for rhC1INH in Europe and are doing our best to provide rhC1INH to treat the unmet medical need of HAE patients.” said Dr. Jan Nuijens, Director Clinical Development at Pharming. “We are also looking forward to initiating our clinical trials for the product for patients in the United States as soon as possible.” In the Phase II clinical study, all patients of HAE treated with rhC1INH showed rapid time to beginning of relief and time to complete resolution as well as favourable evaluation of treatment by both patients and physicians. Pharming expects first market launch of the product in Europe in 2005. Pharming is developing recombinant human C1 inhibitor for the treatment of Hereditary Angioedema (HAE). HAE is a genetic disorder caused by a deficiency of the C1 inhibitor protein in patients. In the Western world, approximately 1 in 30,000 people suffer from HAE. The disease is characterized by acute attacks resulting in swelling of soft tissues, including in regions of the skin, the gut, the throat and mouth. If the soft tissue of the throat is involved, an attack of HAE can be fatal.
