Shield Therapeutics - ACCRUFeR® launched in Canada
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RNS Number : 0672A
Shield Therapeutics PLC
11 March 2025
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 thatit has launched ACCRUFeR® in Canada inpartnership with its
Canadian partner,Kye Pharmaceuticals, Inc. ("Kye").This followsapproval inAugust 2024fromHealth Canadafor
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 agreementShield 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 aprescription 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."
For further information please contact:
Shield Therapeutics plc
Anders Lundstrom, CEO
Santosh Shanbhag, CFO
Stephanie Hicks, Investor Relations
www.shieldtherapeutics.com
+44 (0) 191 511 8500
Investorrelations@shieldtx.com
Nominated Adviser and Joint Broker
Peel Hunt LLP
James Steel
+44 (0)20 7418 8900
Joint Broker
+44 (0)20 7220 0500
Cavendish Ltd
Geoff Nash / Rory Sale / Nigel Birks / Harriet
Ward
Financial PR & IR Advisor
Walbrook PR
Alice Woodings / Lianne Applegarth
+44 (0)20 7933 8780 or shield@walbrookpr.com
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
drughas 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.comandwww.feraccru.com.
ACCRUFeR®/FeRACCRU® has patent coverageuntil 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 coverageuntil the mid-2030s.
ACCRUFeR®/FeRACCRU® are registered trademarks of Shield Therapeutics.
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