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
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Anders Lundstrom, Interim
CEO
Santosh Shanbhag, CFO
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+44 (0)
191 511 8500
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Nominated Adviser and Joint Broker
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Peel Hunt LLP
|
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James Steel / Patrick
Birkholm
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+44 (0)20
7418 8900
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Joint Broker
Cavendish Ltd
Geoff Nash / Rory Sale / Nigel Birks
/ Harriet Ward
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+44 (0)20
7220 0500
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Financial PR & IR Advisor
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Walbrook PR
|
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Charlotte Edgar / Alice
Woodings
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+44 (0)20
7933 8780 or shield@walbrookpr.com
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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 and 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
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.
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.