Pharming Group N.V. has presented its unaudited financial report for the first nine months ended 30 September 2015. CEO Sijmen De Vries comments (in extract):
“During the third quarter, the number of prescriptions for our lead product Ruconest® increased by 29%, which indicates more patients are using Ruconest® to deal with their HAE attacks. We expect to see the effect of this increase in prescriptions continuing through the fourth quarter. The acquisition of our US partner Salix by Valeant Pharmaceuticals International in the first half of 2015 has led to a revision in the way Ruconest® is being marketed in the US. Valeant is concentrating sales effort on larger HAE clinics, which deal with significant numbers of patients with acute HAE attacks, the indication for which Ruconest® is approved.
In July, we went live with the “HAEi GAP” (the Hereditary Angioedema International Patient Organization’s Global Access Program) in collaboration with Clinigen Group PLC, to provide patients with access to Ruconest® in countries where the drug is not yet commercial available. On behalf of their patients, physicians may request Ruconest® through an ethically and regulation-compliant ”Named Patient Program” mechanism. The first requests under this program have already been received by Clinigen.
We have stepped up our research and development activities. We have two ongoing studies: A randomised, double-blind placebo controlled Phase II study for Ruconest® in prophylaxis of HAE, and a Phase II pediatric study for treatment of HAE in young children (2-13 years of age), progressing during the quarter. These studies are expected to finish during the first half of 2016.
After the quarter end, we received notification from the U.S. Food and Drug Administration (FDA) that they have granted Ruconest® extended data exclusivity (from 7 years to 12 years), which means that no bio-similar version of Ruconest® can be approved in the US before July 2026. This should enable us to develop our current pipeline of products to full commercialisation before revenues from Ruconest® come under generic competition.”