Kye Pharmaceuticals announces approval in Canada for ACCRUFeR® (ferric maltol) for the treatment of iron deficiency anemia in adult patients

• 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 (anemia due to iron deficiency)¹.
• Symptoms of ID/IDA can be debilitating and significantly impact health outcomes, work productivity and quality of life in adults^2,3.
• ACCRUFeR is the only oral iron therapy approved as a prescription drug in Canada.

MISSISSAUGA, ON, Aug. 27, 2024 /CNW/ - Kye Pharmaceuticals, Inc. ("Kye"), a commercial-stage biopharmaceutical company focused on identifying, licensing, and commercializing novel medicines for patients in Canada, today announced that ACCRUFeR (ferric maltol) has received market authorization as a prescription medicine in Canada for adults with iron deficiency anemia who are unresponsive or intolerant to other oral iron preparations. Accrufer is currently the only prescription-only oral treatment option indicated for ID/IDA in Canada.

ACCRUFeR® is a novel, stable, non-salt-based, non-polysaccharide oral therapy composed of stable ferric (Fe3+) iron complexed with a naturally occurring sugar derivative, maltol. Unlike traditional oral iron supplements containing ferrous (Fe2+) iron, Fe3+ has been shown to have improved tolerability⁴. The maltol complex protects the iron as it passes through the stomach minimizing gastrointestinal side effects.^5,6

"As the only prescription oral treatment for iron deficiency in Canada, ACCRUFeR is a valuable option between over-the-counter iron supplements and more invasive intravenous preparations" said John McKendry, President & CEO of Kye Pharmaceuticals.  "Advancing our partnership with Shield Therapeutics, contributes to fulfilling our mission to license and commercialize more novel prescription medicines to address areas of high unmet medical need in Canada."

Anders Lundstrom, interim CEO of Shield, commented: "We are delighted with the progress made in partnership with Kye since the signing of the license agreement in January 2022. Both organizations have demonstrated excellent collaboration and are driven to make ACCRUFeR® available to patients in Canada with iron deficiency as quickly as possible. Shield Therapeutics is committed in bringing ACCRUFeR® to patients with iron deficiency around the world, and Canada is an important element of that mission."

About Iron Deficiency and Iron Deficiency Anemia

Clinically low iron levels (iron deficiency, ID) and associated anemia (IDA) can cause serious health problems for adults of all ages, with or without underlying disease conditions³. The Canadian Health Measures Survey (CHMS) estimates that 6.1% of the total Canadian population have ID, with females being more disproportionately affected (8.3%) versus males (4%)¹. 

About ACCRUFeR®

As the only Health Canada approved prescription oral iron to treat ID/IDA, ACCRUFeR has the potential to meet an important unmet medical need for both physicians and patients. Gastrointestinal side effects present a major challenge in adhering to traditional salt-based oral iron supplements⁷. In clinical trials, Accrufer® has been shown to correct IDA by normalizing serum iron markers and was well tolerated in diverse patient populations⁸. More information about ACCRUFeR®, can be found at: www.kyepharma.com.

About Shield Therapeutics plc

Shield is a commercial-stage specialty pharmaceutical company that delivers ACCRUFeR® (ferric maltol), an innovative and differentiated pharmaceutical product, to address a significant unmet need for patients suffering from iron deficiency, with or without anaemia. The Company has launched ACCRUFeR® in the U.S. with an exclusive, multi-year commercial agreement with Viatris Inc. (Viatris). Outside of the U.S., the Company has licensed the rights to four specialty pharmaceutical companies. Feraccru® is commercialised in the UK and European Union by Norgine B.V. (Norgine), 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 (Korea Pharma); and with Kye Pharmaceuticals Inc. for Canada. To learn more about Shield Therapeutics, see our website at www.shieldtherapeutics.com. ACCRUFeR®/Feraccru® are registered trademarks of Shield Therapeutics.

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 may not otherwise be available to patients across Canada. With a growing pipeline of novel medicines, Kye's portfolio spans a range of therapeutic areas including cardiology, psychiatry, pediatrics, rare diseases, hematology, neurology 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 licensing and launching medicines that matter by delivering better outcomes to our partners, Canadian healthcare professionals, and most importantly, patients across Canada. For more information please visit www.kyepharma.com.

1. Cooper M, et al. J Nutr. 2023;153(5) :1534-1543
2. Camaschella C. N Engl J Med. 2015;372(19) :1832-43
3. https://www.who.int/health-topics/anaemia#tab=tab_2 (accessed July 2024)
4. Khoury A, et al. Ann Pharmacother. 2021;55(2):222-229
5. Gasche C, et al. Inflamm Bowel Dis. 2015;21(3) :579‐588
6. Schmidt C, et al. Aliment Pharmacol Ther. 2016; 44(3):259‐270
7. Tolkien Z, et al. Plos One. 2015;10(2):e0117383
8. Pergola PE, et al. Am J Kidney Dis. 2021:S0272-6386(21)00624-7

SOURCE Kye Pharmaceuticals Inc.

For further information please contact: Kye Pharmaceuticals Inc., www.kyepharma.com; John McKendry, President & CEO, [email protected], 1-888-822-7126; Denise David, Vice-President Scientific Affairs, [email protected], 1-888-822-7126