Shield Therapeutics PLC (QB) (SHIEF) 銘柄情報

$SHIEF: Accrufer accepted by Health Canada

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https://www.shieldtherapeutics.com/wp-content/uploads/2022/03/STX-IMC-presentation-March-2022.pdf


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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 shield@walbrookpr.com
Investor Contact (US Advisor)
LifeSci Advisors, LLC
John Mullaly +1 617 429 3548 or jmullaly@lifesciadvisors.com
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