Pharming Group N.V. Announces Presentation Of New Ruconest Clinical Data

Pharming Group N.V. announced that it has presented clinical safety and efficacy data for Ruconest (recombinant human C1 inhibitor, or rhC1INH) at the annual meeting of the European Academy of Allergy and Clinical Immunology (EAACI), Geneva, Switzerland, 16 to 20 June 2012. The new data covers a number of aspects that are relevant to the increasing number of physicians that use Ruconest in the day-to-day treatment of HAE patients in the European Union: Efficacy and safety data for Ruconest in the treatment of adolescents suffering from acute attacks of HAE; underpinning a potential extension of the European labeling of Ruconest and "real-life" experience by French physicians; building confidence in Ruconest by successful treatment with Ruconest of a HAE patient that previously failed various other treatments. In addition an analysis of a previously reported open-label study to explore potential benefits of Ruconest in prophylaxis of HAE, potentially an additional indication that could be explored. RUCONEST Phase III Study Pharming is conducting a Phase III clinical study with RUCONEST under a Special Protocol Assessment (SPA) that is intended to support the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA).