Tuesday, June 12, 2012 9:15:58 AM
Roth Capital Partners and Nomura Code to assist in exploring strategic alternatives
Leiden, The Netherlands, June 12, 2012. Biotech company Pharming Group NV (“Pharming” or “the Company”) (NYSE Euronext: PHARM) today announces that it has engaged Roth Capital Partners and Nomura Code to assist it in exploring strategic alternatives and provides an update on Study 1310 for Ruconest.
As the European capital markets continue to be challenging for Life Science companies, Pharming’s Board and management team have engaged Nomura Code alongside long term advisor, Roth Capital Partners, to assist in a review of strategic options which could include a merger, equity investment or sale. No decision has been made to enter into any specific transaction at this time and there is no certainty that Pharming will enter into a transaction in the future. Th is review will be accompanied by additional cost containment measures and the ongoing discussions on platform technology collaborations. We expect to be able to update the market in Q3, 2012. Recruitment for Pharming's Study 1310, the US pivotal trial for Ruconest is ongoing (68 patients recruited to date) and it is expected that full enrollment (75 patients) could be achieved within the next few weeks, in line with expectations. However, an internal oversight has recently come to our 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 (expe rienced an attack or reached the 90 day mark), the data base will be locked and data analysis will begin. Our 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 2012.
Completion of Study 1310 and read-out of the top-line results will, if positive, trigger a US$10 million milestone payment from Pharming's US partner Santarus Inc.
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