Shield Therapeutics announces the New Drug Application for Feraccru® has been accepted for filing and review by the FDA
London, UK, 3rd December 2018: Shield Therapeutics plc (LSE:STX), a commercial stage, pharmaceutical company delivering innovative specialty pharmaceuticals to address patients’ unmet medical needs, today announces that the US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Feraccru®, Shield’s lead product. Under the terms of the Prescription Drug User Fee Act (PDUFA), the FDA will shortly confirm to Shield the expected target date in 2019 for completion of the NDA review and Shield will provide a further update at that time.
Feraccru® is already approved in the European Union for the treatment of iron deficiency in adults and in Switzerland for the treatment of iron deficiency anaemia in adults with inflammatory bowel disease. The United States, representing over a third of the global pharmaceutical market, is a highly attractive opportunity for Feraccru® and a market which Shield retains full ownership of, as well as complete control of the global intellectual property rights.
In September 2018, Feraccru® was licensed to Norgine B.V. in all European territories not already partnered as well as Australia and New Zealand. In return Norgine B.V. paid a licence fee of £11m, with scope for additional milestones totalling EUR54.5m and royalties on sales ranging from 25% up to 40%.
Commenting on the announcement, Dr Jackie Mitchell, VP of Regulatory Affairs and Quality at Shield Therapeutics, said: “We are delighted to have achieved this key regulatory milestone in widening Feraccru’s geographical availability for patients suffering from iron deficiency. We look forward to interacting positively with the FDA over the coming months and, if approved, Feraccru will provide a novel and much needed treatment option for patients with iron deficiency.”
Carl Sterritt, Chief Executive Officer of Shield Therapeutics, added: “News that the NDA has been validated and accepted for review by the FDA brings us a major step closer to Feraccru potentially being approved in the USA in 2019. Following the licensing agreement we signed with Norgine in September for the commercialisation of Feraccru in Europe, Australia and New Zealand, we are well-funded and are increasingly excited about Feraccru’s future as we continue to enact our plans to realise the value creation opportunities that lie ahead for Shield and its shareholders .”