REG - Shield Therapeutics - ACCRUFeR® launched in Canada

Shield TherapeuticsAnnouncement

11/03/2025 07:00

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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 that
it has launched ACCRUFeR® in Canada in partnership with its Canadian partner,
Kye Pharmaceuticals, Inc. ("Kye"). This follows approval in August 2024
(https://www.londonstockexchange.com/news-article/STX/accrufer-r-approved-by-health-canada/16634602)
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."

 

For further information please contact:

 

 Shield Therapeutics plc                                                                        www.shieldtherapeutics.com (http://www.shieldtherapeutics.com/)
 Anders Lundstrom, CEO                                                                          +44 (0) 191 511 8500

 Santosh Shanbhag, CFO                                                                          Investorrelations@shieldtx.com

 Stephanie Hicks, Investor Relations

 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 (mailto: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 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 (http://www.accrufer.com) and www.feraccru.com
(http://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
(https://c212.net/c/link/?t=0&l=en&o=2852433-1&h=3570787802&u=http%3A%2F%2Fwww.kyepharma.com%2F&a=www.kyepharma.com)
.

 

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

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

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