Company Announcements

Shield Therapeutics plc

("Shield" or the "Company" or the "Group")

KYE Pharmaceuticals Inc. Files Accrufer® New Drug Submission in Canada for the Treatment of Iron Deficiency

London, UK - 21 March 2022: Shield Therapeutics plc (LSE: STX), a commercial stage pharmaceutical company with a focus on treating iron deficiency with its lead product Accrufer®/Feraccru® (ferric maltol), announces that KYE Pharmaceuticals Inc. ('KYE') has submitted a New Drug Submission ('NDS') to Health Canada for the regulatory review and approval of Accrufer®.

If approved, Accrufer® would be the first prescription only oral iron therapy approved by Health Canada. Marketing approval for Accrufer® is expected to be during first half of 2023.

Doug Reynolds, President of KYE, said: "The Shield and KYE teams worked tremendously hard to compile the Canadian NDS in a matter of months and I am extremely pleased to have achieved this milestone."

José A. Menoyo, MD, Chief Medical Officer for Shield, added: "We are delighted with the rapid progress made in partnership with KYE since the signing of the license agreement in January 2022. Both organisations have demonstrated excellent collaboration and are driven to make Accrufer® available to patients in Canada with iron deficiency as quickly as possible.  Shield Therapeutics is committed in bringing Accrufer®/Feraccru® to patients with iron deficiency around the world, and Canada is an important element of that mission."

Shield is eligible to receive £850,000 in development and sales milestones comprised of a payment of £250,000 upon regulatory approval of Accrufer® by Health Canada and up to £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®. 

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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 commercialised 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 commercialisation 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.