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
Hans-Peter Rudolf, CFO
+44 (0) 191 511 8500
Nominated Advisor and Joint Broker
Peel Hunt LLP
James Steel / Christopher Golden
+44 (0) 20 7418 8900
Geoff Nash / George Dollemore / Alice Lane / Nigel Birks
+44 (0) 20 7220 0500
Financial PR & IR Advisor
Lianne Applegarth / Alice Woodings
+44 (0) 20 7933 8780 or email@example.com
Investor Contact (US Advisor)
LifeSci Advisors, LLC
+1 617 429 3548 or firstname.lastname@example.org
Accrufer®/Feraccru® (ferric maltol) is a novel, stable, non-salt based oral therapy for adults with iron deficiency, with or without anemia. Accrufer®/Feraccru® has a novel mechanism of absorption compared to other oral iron therapies and has been shown to be an efficacious and well-tolerated therapy in a range of clinical trials. More information about Accrufer®/Feraccru®, including the product label, can be found at: www.accrufer.com and www.feraccru.com
About Shield Therapeutics plc
Shield is a commercial stage specialty pharmaceutical company with a focus on addressing iron deficiency with its lead product Accrufer®/Feraccru® (ferric maltol). The Group has launched Accrufer® in the US and Feraccru® is commercialized in the UK and European Union by Norgine B.V., who also have the marketing rights in Australia and New Zealand. Shield also has an exclusive license agreement with Beijing Aosaikang Pharmaceutical Co., Ltd., for the development and commercialization of Accrufer® / Feraccru® in China, Hong Kong, Macau and Taiwan, with Korea Pharma Co., Ltd. in the Republic of Korea, and with KYE Pharmaceuticals Inc. in Canada.
Accrufer®/Feraccru® has patent coverage until the mid-2030s
Accrufer®/Feraccru® are registered trademarks of the Shield Group
Shield Therapeutics plc
July 14, 2022 at 2:00 AM EDT