Pharming Group: unblinding of Study 1310 top-line data could be delayed

theflyonthewall.com

Recruitment for Pharming's Study 1310, the US pivotal trial for Ruconest is ongoing - with 68 patients recruited to date - and it is expected that full enrollment of 75 patients could be achieved within the next few weeks, in line with expectations. However, an internal oversight has recently come to the company's attention that could potentially delay the unblinding of the top-line data by up to three months in order to complete the statistical package required by the FDA. This matter is currently being investigated. The potential delay relates to the final step to completion of the trial consists of an additional blinded follow up period of up to 90 days, depending on when patients experience a subsequent attack. Once the last patient has completed the blinded follow-up period (experienced an attack or reached the 90 day mark), the data base will be locked and data analysis will begin. Pharming's experience with this trial is that participating patients are typically having a subsequent attack significantly sooner than 90 days, which means that locking of the data base and top-line results would still become available in Q3, 2012, however if the last patient entering the trial takes the full 90 days then top line results will be in Q4 of 2012. Completion of Study 1310 and read-out of the top-line results will, if positive, trigger a $10M milestone payment from Pharming's U.S. partner Santarus Inc.