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	[phone]
Hans-Peter Rudolf, CFO
Nominated Adviser and Joint Broker
Peel Hunt LLP
James Steel/Christopher Golden	[phone]
Joint Broker finnCap Ltd  Geoff Nash/ George Dollemore/Alice Lane/Nigel Birks	[phone]
Financial PR & IR Advisor
Walbrook PR
Lianne Applegarth/Alice Woodings	[phone] or  [e-mail]
Investor Contact (US Advisor) LifeSci Advisors, LLC John Mullaly	[phone] or [e-mail]

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

 

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