Business
Business Update
Business Update.
About this update from Shield Therapeutics Plc
[{"type":"text","content":"\n \nRNS Number : 4034V Shield Therapeutics PLC 23 July 2018 \n\nThis announcement contains inside information for the purposes of Article 7 of Regulation 596/2014 \n \nShield Therapeutics plc\n(\"Shield\" or the \"Group\")\nH1 Business Update\n\n \n\n- Feraccru delivered positive results in the pivotal Phase III AEGIS-CKD and AEGIS-Paeds-PK studies\n \n- Feraccru sales stable despite reductions in manpower and promotional activity\n \n- European Commission endorsed a significantly broader indication for Feraccru\n \n- NDA submission for Feraccru remains on course to be filed in 2018\n \n- Advanced discussions with a number of parties to out-license Feraccru in Europe\n \n\n \nLondon, UK, 23rd July 2018: Shield Therapeutics plc (LSE:STX), a commercial stage, pharmaceutical company delivering innovative specialty pharmaceuticals to address patients' unmet medical needs, with an initial focus on addressing iron deficiency with its approved product, Feraccru®, today announces a business update following progress made in H1 2018.\n \nFeraccru update\nNew Drug Application (NDA) submission\nFollowing the Company's detailed analyses of the positive data from the placebo-controlled period of the AEGIS-CKD study, we completed a planned pre-NDA submission meeting with the FDA at which we presented the positive AEGIS-CKD study results together with a broader discussion regarding the Company's intention to file an NDA for Feraccru in 2018. The feedback received meant we have continued preparations for the NDA submission, which remains on course to occur in the second half of the year and is expected to lead to an approval decision being made by the FDA during the second half of 2019.\n \nBroad label in Europe\nH1-18 also saw the European Commission (EC) endorse the EMA's recommendation to grant Feraccru a much broader indication and it can now be used across Europe to treat iron deficiency (ID) with or without anaemia in all adults. This is a very significant event for Feraccru as it provides a significantly broader commercial opportunity in Europe, where 40 million[i] people are estimated to be iron deficient as compared to under half a million with iron deficiency anaemia (IDA) assoc...