REG - Shield Therapeutics - Licence Agreement in Japan for ACCRUFeR®

Shield TherapeuticsAnnouncement

22/04/2025 07:02

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RNS Number : 6440F  Shield Therapeutics PLC  22 April 2025

Shield Therapeutics plc

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

 

Licence Agreement in Japan for ACCRUFeR®

 

Exclusive Japan licence agreement with VITAL-NET, Inc.
Shield to receive an initial payment of ~$665,000 plus regulatory and sales milestones, and double-digit royalties on net sales

 

London, UK, 22 April, 2025:  Shield Therapeutics plc (LSE: STX), a commercial
stage pharmaceutical company specialising in iron deficiency with or without
anemia ("ID/IDA"), announces that it has entered into an exclusive licence
agreement ("the Agreement") for ACCRUFeR® with VITAL-NET, Inc. ("VITAL-NET")
in Japan. VITAL-NET will undertake and be responsible for all costs, including
clinical and regulatory, related to activities required to achieve marketing
authorisation and commercialisation of ACCRUFeR® in Japan.

 

Shield will receive an initial payment of circa $665,000 and is eligible to
receive additional milestone payments related to the regulatory approval of
ACCRUFeR® and upon the achievement of specified net sales targets by
VITAL-NET. For the term of the agreement, Shield will also receive
double-digit royalties on net sales of ACCRUFeR®. VITAL-NET to be responsible
for, and cover costs of all development and regulatory activity.

 

Anders Lundstrom, Chief Executive Officer for Shield, commented: "This
partnership aligns with our commitment to keep expanding our global footprint
for ACCRUFeR®. Japan, the third largest pharmaceutical market in the world,
is an important market to enter as Iron deficiency is a prevalent health
concern in Japan, especially among women, children, and the elderly.
ACCRUFeR® offers a new option for those who need a more effective treatment
to restore their iron levels and improve their overall health. We look forward
to working together with VITAL-NET to making ACCRUFeR® available to the
people of Japan."

 

Takeshi Ichijo, CEO of VITAL-NET, commented: ""We are excited to have entered
into the agreement with Shield Therapeutics for the supply, development and
marketing of ACCRUFeR®. Iron deficiency (ID) patients in pulmonary
hypertension (PH) and inflammatory bowel disease (IBD) are our important
areas, we believe that our experience will be of great use. We will endeavour
to provide the drug to Japanese patients suffering from ID."

 

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

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.

 

Iron deficiency and iron deficiency anemia (ID/IDA) poses a significant health
challenge in Japan, with the country accounting for approximately 39% of ID
cases among the seven major markets, which include the USA, EU5 (the UK,
Italy, Spain, France, and Germany), and Japan 1 . The ID/IDA treatment
landscape in Japan primarily consists of oral and intravenous (IV) iron
supplements. Oral iron products, including both over-the-counter and
prescription formulations, dominate the market in terms of volume 2 .

The Japanese iron deficiency therapy market is poised for growth. This growth
is attributed to factors such as the introduction of novel therapies, an
increasing IDA prevalence, and heightened awareness regarding anemia
management 3 .
(https://www.prnewswire.com/news-releases/iron-deficiency-anemia-market-size-growth-to-shore-up-with-a-cagr-of-3-7-during-the-study-period-2018-30-in-the-7mm--delveinsight-301386378.html?utm_source=chatgpt.com)
Japan's ID/IDA market is characterized by a robust demand for both oral and IV
iron supplements, influenced by regional demographics and recent
pharmaceutical innovations2. The market is expected to expand steadily, driven
by ongoing advancements in treatment options and a growing focus on addressing
iron deficiency and iron deficiency anemia3.

 

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) .

 

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.

 

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

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

 

About VITAL-NET, Inc.

The core business of VITAL-NET is the wholesale of prescription
pharmaceuticals and to serve the health of the people

and contribute to the fostering of a healthy society. VITAL-NET was founded in
1950 and has supported the lives, health, and well-being of the community up
to the present day. Our commitment lies in being "community-oriented."
Starting from Miyagi Prefecture as a pharmaceutical wholesaler, we have
expanded our sales areas to six prefectures in the Tohoku region, as well as
Niigata, Tochigi, and the Tokyo metropolitan area, creating a network of
branches as intricate as capillaries. Our deeply rooted business activities
and experiences have earned high praise not only from medical institutions but
also from local governments, administrative bodies, and industry
organizations. We have established agreements for disaster response and
collaborations for promoting health in various regions. The speed of changes
in the social environment, such as declining birthrates and an aging
population, uneven distribution of medical resources, natural disasters, and
pandemics, as well as in the business environment, like medical DX, online
medical consultations, and the emergence of groundbreaking new drugs, is
increasing. However, our role as a social infrastructure to support the
provision of safe and secure medical care to patients at any time remains
unchanged. To fulfil this responsibility, we pursue new services tailored to
regional needs, including stringent quality control of prescription
pharmaceuticals, the sale and rental of the latest medical equipment, and life
support. We will also challenge new roles as partners in rapidly advancing
medical care. VITAL-NET's strength lies in the "human power" of each employee
recognising and executing our corporate philosophy of "serving people's
medical care and health," as well as in our network with the community.

 

 1  Anemia Market Insight, Epidemiology and Market Forecast
(https://www.globenewswire.com/news-release/2021/08/24/2285365/0/en/Anemia-Market-Insight-Epidemiology-and-Market-Forecast-2030.html?utm_source=chatgpt.com)

 2  Clinical management of iron deficiency anemia in Japan: iron prescription
patterns, treatment effectiveness, and assessments - PMC
(https://pmc.ncbi.nlm.nih.gov/articles/PMC11284196/?utm)

 3  Iron Deficiency Anemia Therapy Market Size Report, 2030
(https://www.grandviewresearch.com/industry-analysis/iron-deficiency-anemia-therapy-market-report)

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