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Trial delay prompts Pharming to look at "strategic alternatives"

Dutch biotech awaits key milestone payment relating to its lead drug Ruconest

Ruconest - Pharming

Dutch biotechnology company Pharming is considering a range of strategic alternatives, including a possible sale of the company, as it faces a delay in securing a key milestone payment relating to its lead drug Ruconest.

Pharming has hired Roth Capital Partners and Nomura Code to assist with the decision making process as it contemplates "a merger, equity investment or sale," and also said it would take additional cost-cutting actions to conserve cash.

The prompt for the review has come from an "internal oversight" that could delay the un-blinding of a pivotal US trial (study 1310) of Ruconest (conestat alfa) in hereditary angioedema by up to three months.

Although recruitment into the trial is progressing on schedule, Pharming will have to carry out additional work on the statistical package from the trial in order to meet FDA requirements, which could delay the generation of top-line results until the third or fourth quarter of 2012.

Ruconest is already approved for marketing in Europe, but sales remain modest at just €394,000 in the first quarter of this year.

Pharming has been funding itself in the first half of 2012 via an €8.4m convertible bond, but was counting on a $10m milestone payment from US marketing partner Santarus on the read-out of data from the US trial to help support operations in the latter half of the year and 2013.

Another $5m is payable on filing of a Biologics License Application (BLA) for Ruconest, provided the US trial data are positive. That filing - the second attempt by Pharming and Santarus after the FDA refused to accept an earlier application in February 2011 - had been expected in the first quarter of 2013.

In a statement, the Dutch biotech noted that the European capital markets "continue to be challenging for life science companies".

13th June 2012

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