KYE Pharmaceuticals Files Accrufer® New Drug Submission in Canada for the Treatment of Iron Deficiency

MISSISSAUGA, ON, March 21, 2022 /CNW/ - KYE Pharmaceuticals Inc. ("KYE"), a private company headquartered in Mississauga, Ontario and focused on bringing medicines that fulfill clinically significant unmet needs to the Canadian market, today announced it has submitted a New Drug Submission (NDS) to Health Canada for the regulatory review and approval of Accrufer® (ferric maltol).

If approved, Accrufer® would be the first prescription only oral iron therapy approved by Health Canada and marketing approval for Accrufer® is expected to be during the first half of 2023.

Doug Reynolds, President of KYE, said: "The Shield and KYE teams worked tremendously hard to compile the Canadian NDS in a matter of months and I am extremely pleased to have achieved this milestone."

José A. Menoyo, MD, Chief Medical Officer for Shield, added: "We are delighted with the rapid progress made in partnership with KYE since the signing of the license agreement in January. 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®/Feraccru® to patients with iron deficiency around the world, and Canada is an important element of that mission."

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 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 US and EU product labels, can be found at: www.accrufer.com and www.feraccru.com.

About KYE Pharmaceuticals

KYE Pharmaceuticals is a private company headquartered in Canada focused on bringing medications to the Canadian market which fulfill clinically significant and unmet needs. KYE has licensed many innovative products and was founded on an entrepreneurial spirit that optimizes our team's strengths and brings unique value to our partners, Canadian healthcare professionals, and most importantly, our patients. For more information please visit www.kyepharma.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

SOURCE KYE Pharmaceuticals Inc.

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