Shield Therapeutics plc

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

ACCRUFeR® launched in Canada

ACCRUFeR® is the sole prescription-only oral treatment for iron deficiency anemia in Canada

London, UK, 11 March 2025: Shield Therapeutics plc (LSE: STX), a commercial stage pharmaceutical company specialising in iron deficiency, announces that it has launched ACCRUFeR® in Canada in partnership with its Canadian partner, Kye Pharmaceuticals, Inc. ("Kye"). This follows approval in August 2024 from Health Canada for ACCRUFeR® (ferric maltol) as a prescription drug for the treatment of adults with iron deficiency anemia ("IDA").

ACCRUFeR® is currently the sole prescription-only oral treatment option indicated for IDA in Canada and is available by prescription through pharmacies across Canada. Shield will be responsible for all manufacturing and supply to the Canadian market.

In accordance with the collaborative agreement Shield is eligible to receive further milestone payments upon the achievement of specified calendar net sales targets and will also receive double-digit royalties on net sales of ACCRUFeR® for the term of the agreement. 

Iron deficiency is a public health concern with an estimated 6-7% of people living in Canada being iron deficient (ID), and ~2% of the population classified as having IDA. ACCRUFeR® is approved as a prescription medicine in Canada for adults with IDA who are unresponsive or intolerant to other oral iron preparations. 

Anders Lundstrom, Chief Executive Officer, commented: "We continue to expand the global footprint for ACCRUFeR® with the launch in Canada. We are delighted with the progress by Kye following approval of ACCRUFeR® by Health Canada in August 2024. Both organisations continue to demonstrate excellent collaboration in making ACCRUFeR® available to patients in Canada with iron deficiency as quickly as possible."

Julian Oliver, Commercial Lead General Medicines and Business Operations, Kye Pharmaceuticals, commented: "The availability of ACCRUFeR® across Canada provides patients and physicians with a valuable treatment option between over-the-counter iron supplements and more invasive intravenous iron preparations. We are proud to bring an evidence-based oral iron-therapy to Canada that has demonstrated long-term efficacy and safety in both placebo-controlled and active comparator clinical trials. We look forward to supporting efforts across Canada to raise awareness, enhance screening, and improve access to treatment of ID and IDA, making a meaningful difference in patient care."

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About Iron Deficiency and ACCRUFeR®/FeRACCRU®

Clinically low iron levels (aka iron deficiency, ID) can cause serious health problems for adults of all ages, across multiple therapeutic areas. Together, ID and ID with anemia (IDA) affect about 20 million people in the US and represent a $2.3B market opportunity. As the first and only FDA approved oral iron to treat ID/IDA, ACCRUFeR® has the potential to meet an important unmet medical need for both physicians and patients.

ACCRUFeR®/FeRACCRU® (ferric maltol) is a novel, stable, non-salt-based oral therapy for adults with ID/IDA. The drug 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.

ACCRUFeR®/FeRACCRU® has patent coverage until the mid-2030s.

ACCRUFeR®/FeRACCRU® are registered trademarks of Shield Therapeutics.

About Shield Therapeutics plc

Shield is a commercial stage specialty pharmaceutical company that delivers ACCRUFeR®/FeRACCRU® (ferric maltol), an innovative and differentiated pharmaceutical product, to address a significant unmet need for patients suffering from iron deficiency, with or without anemia. The Company has launched ACCRUFeR® in the U.S. with an exclusive, multi-year collaboration agreement with Viatris Inc. Outside of the U.S., the Company has licensed the rights to four specialty pharmaceutical companies. FeRACCRU® is commercialized in the UK and European Union by Norgine B.V., which also has 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. for the Republic of Korea, and with KYE Pharmaceuticals Inc. for Canada.

About Kye Pharmaceuticals Inc.

Kye is a growth-stage Canadian specialty pharmaceutical company committed to bringing value to Canadians by identifying, licensing, and commercializing novel prescription medicines that are not otherwise available to patients across Canada. With a growing pipeline of innovative medicines, Kye's portfolio spans a range of therapeutic areas including neurology, psychiatry, pediatrics, rare diseases, hematology, cardiology and neuromuscular disorders. Kye Pharmaceuticals is a private company headquartered in Toronto focused on bringing medications to the Canadian market which fulfill clinically significant unmet needs. Kye is committed to delivering better outcomes to our partners, Canadian healthcare professionals, and most importantly, patients across Canada. For more information please visit www.kyepharma.com.

ACCRUFeR®/FeRACCRU® has patent coverage until the mid-2030s.

ACCRUFeR®/FeRACCRU® are registered trademarks of Shield Therapeutics.