Shield Therapeutics - New Drug Submission accepted by Health Canada

RNS Number : 4029S Shield Therapeutics PLC 14 July 2022   Shield Therapeutics plc ("Shield" or the "Company" or the "Group")   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 www.shieldtherapeutics.com Greg Madison, CEO +44 (0) 191 511 8500 Hans-Peter Rudolf, CFO   Nominated Adviser and Joint Broker Peel Hunt LLP James Steel/Christopher Golden +44 (0)20 7418 8900   Joint Broker finnCap Ltd      Geoff Nash/ George Dollemore/Alice Lane/Nigel Birks                                                   +44 (0)20 7220 0500 Financial PR & IR Advisor Walbrook PR Lianne Applegarth/Alice Woodings +44 (0)20 7933 8780 or [email protected] Investor Contact (US Advisor) LifeSci Advisors, LLC John Mullaly     +1 617 429 3548 or [email protected]   About Accrufer®/Feraccru® 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     This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact [email protected] or visit www.rns.com. RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our Privacy Policy.   END     MSCFLFVRDLIVLIF

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