From the Pharming Group N.V. financial report for the first quarter ended 31 March 2016:
- During the quarter we initiated sales of Ruconest in the countries which Pharming now commercializes directly, in Germany, Austria and the Netherlands . These countries had proved very difficult for our partner SOBI prior to 2015 when we agreed to take them back. We are encouraged by feedback so far and look forward to building on this.
- The Q1 result show that the change to strategy is now bearing fruit and the sales growth of Ruconest is more pronounced from March onwards, with more patients starting to switch to Ruconest in all our major markets. In addition to the new sales in our own territories, SOBI continues to do well in Eastern Europe. We have also seen requests for Ruconest from new patients through the HAEi Global Access Program conducted with the HAEi, the International Patient Organization for C1-Inhibitor Deficiencies, in association with Clinigen Group plc. The “HAEi GAP” program provides access to Ruconest for eligible patients with HAE who currently do not have access to effective medication to treat acute attacks of the disease, such as certain Gulf states and much of Africa. In Colombia, our partner Cytobioteck continues to make progress, and has represented Ruconest at the recent HAE conference and seminar there.
- We continue to make good progress in our efforts to develop our pipeline to produce the next generation of therapies. Our first program lead has been optimized and the second is under way. We will be announcing the details of these programs and the timetable of their clinical development in the next few months.
- Late in the quarter, the European Commission adopted the CHMP recommendation to include the treatment of HAE attacks in adolescents and to remove the requirements for rabbit IgE testing that previously formed part of the EU label for Ruconest. The CHMP also noted that the importance of favorable effects of Ruconest is further supported by the continued availability of supply of Ruconest (produced by recombinant technology) in comparison to supply from blood donor plasma that may vary, and that as it is not a blood derived product Ruconest carries no potential risk of exposure to blood-borne pathogens.
- Our clinical Phase II randomized, double-blind, placebo-controlled study of Ruconest in prophylaxis of HAE continues on track and we remain on track to announce the preliminary results of this trial by the end of June/ early July.