Accrufer® New Drug Submission accepted by Health Canada
NDS filed by Partner, KYE Pharmaceuticals Inc., for Regulatory Review has been accepted
Marketing approval expected mid-2023
London, UK – 14 July 2022: Shield Therapeutics plc (LSE: STX), a commercial stage pharmaceutical company with a focus on treating iron deficiency with its lead product Accrufer®/Feraccru®, announces that Health Canada have screened and accepted the Accrufer® New Drug Submission (“NDS”), filed by Shield’s Licensing Partner, KYE Pharmaceuticals Inc. (“KYE”) earlier this year.
Health Canada are expected to complete their regulatory review in mid-2023 and a successful outcome will allow KYE to market Accrufer® in Canada. Shield will be responsible for all manufacturing and supply to the Canadian market.
Upon regulatory approval of Accrufer® by Health Canada, Shield is due to receive a £250,000 milestone payment. In addition, Shield would be eligible for an additional £600,000 in milestone payments upon the achievement of specified calendar net sales targets. For the term of the agreement, Shield will also receive double-digit royalties on net sales of Accrufer®.
For further information please contact:
Shield Therapeutics plc
Greg Madison, CEO
+44 (0) 191 511 8500
Hans-Peter Rudolf, CFO
