Last checked at 31 Oct 2022 07:00
Shield Therapeutics plc
("Shield" or the "Company" or the "Group")
Shield announces regulatory pathway and timelines for Accrufer® approval in the Republic of Korea
London, UK, 31 October, 2022: Shield Therapeutics plc (LSE: STX), a commercial stage, pharmaceutical company with a focus on addressing iron deficiency with its lead product Accrufer®/Feraccru® (ferric maltol), announces that the Korean Food and Drug Administration has agreed that a single pharmacokinetic (PK) study is the only additional study requirement to support a New Drug Application (NDA) submission for Accrufer®. The study is expected to be initiated in Q4 2022 and will be conducted by the Company's partner, Korea Pharma Co. Ltd (Korea Pharma), who have development and commercialisation rights for Accrufer® in the Republic of Korea.
Korea Pharma expects regulatory approval allowing the commercial launch of Accrufer® in the Republic of Korea in late 2023.
Greg Madison, CEO of Shield Therapeutics, stated: "We are delighted that the pathway to regulatory approval for commercialisation of Accrufer® in Korea has been established, and that our partner, Korea Pharma, is now ready to commence the study required to support the NDA submission. There are an estimated 5.2 million people in the Republic of Korea with iron deficiency and iron deficiency anemia, in need of novel treatment options. We look forward to supporting our partner as they continue on the pathway to potentially make Accrufer® available to patients."
For further information please contact:
Shield Therapeutics plc | www.shieldtherapeutics.com |
Greg Madison, CEO | +44 (0) 191 511 8500 |
Hans-Peter Rudolf, CFO |
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Nominated Adviser and Joint Broker |
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Peel Hunt LLP |
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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 |
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Financial PR & IR Advisor |
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Walbrook PR |
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Lianne Applegarth/Alice Woodings | +44 (0)20 7933 8780 or shield@walbrookpr.com |
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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 action 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