Pharming Group N.V. presents its (unaudited) financial report for the first nine months and the third quarter ended 30 September 2017.
Operational highlights during the third quarter
- On September 11, following the conclusion of the End-of-Phase 2 interactions with the US Food and Drug Administration (FDA), Pharming announced that it will submit a supplemental Biologics License Application (sBLA) to the FDA for review in Q4 of this year for prophylaxis of angioedema attacks in adolescent and adult patients with hereditary angioedema (HAE) as an expanded indication for Ruconest [Recombinant Human C1 Esterase Inhibitor/ conestat alfa]
- On September 26, the Company, in association with HAEi announced the appointment of Inceptua Medicines Access as their new distribution partner for the “HAEi Global Access Program” (HAEi GAP) enabling patients in all countries where Pharming’s product Ruconest is not commercially available to gain access to the drug through an ethical and regulatory-compliant mechanism
- Positive results were obtained from a Phase II clinical trial investigating the use of Ruconest for the treatment of HAE attacks in children.
“We are on the right track with our strategy for Ruconest in all markets. We now see real growth in terms of both volume and value for Ruconest. In addition, we continue to make good progress with our pipeline research and development programs.
Towards the end of the quarter we were informed of acute shortages of HAE medication as a result of manufacturing issues for certain competitor HAE products, mainly in the US. To help resolve this situation for patients, we immediately offered instant access to our patient care programme, Ruconest Solutions, including its free starter medication and bridging support for those patients in acute need of alternative medication to treat their HAE attacks. We have therefore been supplying considerable amounts of Ruconest free-of-charge to cover treatment of attacks for the period during which those patients are being cleared for Ruconest reimbursement. Patients are at the very centre of Pharming’s business and we are doing our best to ensure that HAE patients get effective treatment. As a result of this situation, we have accelerated planned increases in capacity across our supply chain. We do not believe this situation has had any real effect on our results for the third quarter, but it is likely to have a positive effect on the company’s performance in the fourth quarter.”