Pharming Group N.V. presents its financial report for the nine months ended 30 September 2016. From CEO Sijmen de Vries’ comments:
- After a relatively modest start to sales of Ruconest® (recombinant C1 esterase inhibitor, 50 IU/kg) in 2016, revenue growth during the third quarter has significantly increased. Sales efforts in the US drove this growth. We are very pleased with these results, which show Pharming is now growing towards profitability and, together with the transformational acquisition of the North American rights to Ruconest® from Valeant, means that we can achieve profitability on an operational level during 2017.
- On 9 August 2016, the Company announced that it has entered into a definitive agreement to acquire all North American commercialization rights to its own product Ruconest®, including all rights in the US, Mexico and Canada, from Valeant Pharmaceuticals International, Inc.
- On 18 July 2016, we announced compelling data from our Phase II clinical study of Ruconest® for prophylaxis in patients with HAE. In the study, Ruconest® showed a clinically relevant and statistically significant reduction in attack frequency for both the twice- weekly (p-value <0.0001) and once-weekly (p-value = 0.0004) treatment regimens as compared with placebo. The secondary endpoint showed a 72 % average reduction in the number of breakthrough attacks and a response rate of up to 96 % in the twice-weekly treated per protocol group of patients, corroborating reports from day-to-day use of Ruconest®. The US prophylaxis of HAE market is expected to be around $800 million in 2017, with only one product currently approved for this market. This represents a huge potential market for Ruconest®, which, if approved, would be the only recombinant C1 esterase inhibitor approved for both acute attacks and prophylactic therapy.
- On 14 July 2016, we announced that we had updated our distribution agreement with Swedish Orphan Biovitrum AB and as of 1 October 2016, Pharming took over responsibility for direct commercialization of Ruconest® in a further 21 countries. SOBI had not yet begun significant sales efforts in most of these countries. The countries include the major EU markets of the UK, France and Spain, and a number of countries across Europe and the Middle East which do not yet have optimal access to therapies for HAE. In some of these countries we will continue to act in partnership with the HAEi Global Access Program (“HAEi GAP”).