REG - Shield Therapeutics - ACCRUFeR® Approved by Health Canada

Shield TherapeuticsAnnouncement

27/08/2024 07:00

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RNS Number : 6485B  Shield Therapeutics PLC  27 August 2024

  Shield Therapeutics plc

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

 

ACCRUFeR® Approved by Health Canada

 

ACCRUFeR® is the only oral iron therapy approved as a prescription drug in
Canada

 

 

London, UK, 27 August 2024: Shield Therapeutics plc (LSE: STX), a commercial
stage pharmaceutical company that delivers ACCRUFeR®/FeRACCRU® (ferric
maltol), an innovative and differentiated specialty pharmaceutical product, to
address a significant unmet need for patients suffering from iron deficiency
(with or without anaemia), today announces that Health Canada has approved
ACCRUFeR® (ferric maltol) as a prescription drug for the treatment of adults
with iron deficiency anemia (IDA).  This development allows Shield's partner,
Kye Pharmaceuticals Inc. (Kye), to launch ACCRUFeR® in Canada. Shield will be
responsible for all manufacturing and supply to the Canadian market.

 

In accordance with the collaborative agreement, Shield is now due to receive a
£250,000 milestone payment. For the remaining term of the agreement, Shield
will receive additional revenue-based milestone payments along with
double-digit royalties on net sales of ACCRUFeR®.

 

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 organisations 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 to bringing ACCRUFeR®/FeRACCRU® to patients with iron deficiency
around the world, and Canada is an important component of that mission."

 

John McKendry, President and CEO of Kye, commented: "ACCRUFeR® will be the
only prescription oral therapy available in Canada to treat patients who
continue to suffer from low iron despite attempts at treatment with other
currently available options. Our partnership with Shield and the granting of
marketing authorization for ACCRUFeR® in Canada grant us the opportunity to
bring a novel, high-quality therapeutic option to patients in Canada who are
struggling to address mild to moderate iron deficiency or iron deficiency
anemia."

 

For further information please contact:

 

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

 Santosh Shanbhag, CFO

 Nominated Adviser and Joint Broker
 Peel Hunt LLP
 James Steel / Patrick Birkholm                                                   +44 (0)20 7418 8900

 Joint Broker

 Cavendish Ltd

 Geoff Nash / Rory Sale / Nigel Birks / Harriet Ward

                                                                                  +44 (0)20 7220 0500

 Financial PR & IR Advisor
 Walbrook PR
 Charlotte Edgar / Alice Woodings                                                 +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 anaemia (IDA) affect about 20 million people in the U.S. 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.

 

In Canada, 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%).  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.

 

ACCRUFeR®/FeRACCRU® (ferric maltol) is a novel, stable, non-salt-based oral
therapy for adults with ID/IDA. 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 product label, can be
found at: www.accrufer.com (http://www.accrufer.com) and www.feraccru.com
(http://www.feraccru.com) .

 

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 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 commercialisation 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
(http://www.shieldtherapeutics.com) or follow us on LinkedIn and X.

 

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

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, and neurology. 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
(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)
.

 

Forward-Looking Statements:

This press release contains forward-looking statements. All statements
contained in this press release that do not relate to matters of historical
fact should be considered forward-looking statements.  These forward-looking
statements are based on management's current expectations and include
statements related to the commercial strategy for ACCRUFeR®/FeRACCRU®. These
statements are neither promises nor guarantees, but involve known and unknown
risks and uncertainties, many of which are beyond our control, that may cause
actual results and performance or achievements to be materially different from
management's expectations expressed or implied by the forward-looking
statements, including, but not limited to, risks associated with the Company's
business and results of operations, competition and other market factors.
The forward-looking statements made in this press release represent
management's expectations as of the date of this press release, and except as
required by law, the Company disclaims any obligation to update any
forward-looking statements contained in this release, even if subsequent
events cause its views to change.

 

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