In the financial report for the full year that ended 31 December 2015 Sijmen de Vries, CEO and
Chairman of the Board of Pharming Group N.V. writes (in extracts):
2015 was the year that Pharming started to move forward again, after years of consolidation and transition. Sales of Ruconest grew well in 2015. This was most strongly seen in the US, where initially Salix Pharmaceuticals Ltd. and thereafter Valeant have continued to roll out Ruconest to patients. The changes in sales organizations caused by this acquisition have impacted the speed of growth, but the overall result was still positive for Pharming.
We are proud that more than 12,000 attacks of HAE have now been successfully treated with Ruconest and that the very low rate of adverse events observed and documented in clinical trials continues to be confirmed. It is already the most effective treatment (based on comparison of published data) for resolution of acute HAE attacks, with no significant side effects and very fast resolution of these painful and frightening episodes for patients. As the only pure recombinant product, it also avoids many of the concerns, complications and costs, such as the formation of potentially life-threatening blood clots and mandatory pre-testing and regular testing for blood-borne infections like Hepatitis B and C and HIV, which are associated with products fractionated from blood plasma, for which the risk of new blood-borne infections (such as Zika virus) also remains significant. As a further testament to Ruconest’s safety profile, the CHMP recently issued a positive opinion to cancel the requirement for rabbit allergy testing in Europe prior to first use and for the label to be extended further to allow it to be used to treat adolescent patients.
Starting in January with the initiation of a randomized double-blind placebo-controlled Phase II clinical trial for Ruconest in prophylaxis of HAE, we have relaunched Pharming as a company engaged in developing new products and markets. Since the year-end, we announced that this trial was fully recruited and we now expect the preliminary outcome from the study in the end of the second quarter of 2016. We have also extended our agreement with Cytobioteck S.A.S to an additional four Latin American countries, reflecting the good start that they have made in bringing Ruconest to patients in Colombia and Venezuela.
In 2015 we also entered into an international global access collaboration for HAEi together with Clinigen Group plc. The “HAEi GAP” program will provide access to Ruconest for eligible patients with HAE who currently do not have access to effective medication to treat acute attacks of the disease, and the first patients are now coming through this program.
We intend to increase our own commercial activities, with additional territories and products as opportunities arise, and to continue to develop our pipeline to produce the next generation of therapies. We expect to announce the full pipeline development program, including the anticipated timings of the clinical trial steps, in the second quarter of 2016 once our program leads have been optimized.
Later in the year, the US Food and Drug Administration granted an extension for Ruconest data exclusivity until 2026. This should enable us to add new revenue-generating products to our arsenal and identify opportunities in 2016 and beyond. It should also enable us to bring these products to market and develop sales under the “extended umbrella” of revenues from Ruconest.
With a solid base built in 2015 and strong opportunities becoming available already, we look forward to an even more positive year in 2016, with strong inflection points from the Phase II prophylaxis study and from increasing sales of Ruconest.