Pharming Completes Recruitment Of Ruconest® US Pivotal Phase III StudyLeiden, The Netherlands, July 05, 2012. Biotech company Pharming Group NV (“Pharming” or “the Company”) (NYSE Euronext: PHARM) today announces that it has reached full recruitment of its ongoing US pivotal Phase III clinical study (Study 1310) evaluating the investigational drug RUCONEST® (recombinant human C1 inhibitor) for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema (HAE). 75 randomized patients are in the study and no further patients will be entered.
Study 1310 will now continue until such time that either all of the treated patients have received an open label treatment for a subsequent HAE attack, or until 90 days have lapsed since their randomized attack. This will be followed by the analysis of the results. Positive results of the study will trigger a US$ 10 million m ilestone payment to Pharming from its US partner Santarus Inc.
Currently 53 of the 75 patients have experienced a repeat attack or achieved a 90 day attack free period.
Bruno Giannetti, COO of Pharming, said, “Completion of recruitment into this clinical study is an important milestone for Pharming. As previously stated, the final step to completion of the trial consists of an additional follow up period of up to 90 days, depending on when patients experience a subsequent attack.
However, it is a generally accepted assumption that approximately one to two attacks occur per month in otherwise untreated HAE patients, suggesting that those individuals in our study may typically experience a subsequent attack significantly sooner than 90 days post their randomized attack.”
