LEIDEN, The Netherlands, April 28, 2004 (PRIMEZONE) -- 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 rhC1INH for the treatment of Hereditary Angioedema. 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 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.
Background on Pharming Group N.V.
Pharming Group N.V. is developing innovative protein therapeutics for unmet medical needs. The Company's products include potential treatments for genetic disorders and specialty products for surgical indications. Pharming's lead product for Hereditary Angioedema is in Phase III of clinical development. The advanced technologies of the Company include novel 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.
Pharming Contact:
Europe: Rein Strijker Pharming Group N.V. T: + 31 (0)71 52 47 406
USA:
Samir Singh Pharming Group N.V. T: + 1 908 720 6224