REG - Shield Therapeutics - New Drug Application for Accrufer® in South Korea

Shield TherapeuticsAnnouncement

28/05/2024 07:00

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RNS Number : 9601P  Shield Therapeutics PLC  28 May 2024

  Shield Therapeutics plc

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

 

Shield's Korean Partner files New Drug Application for Accrufer® in the
Republic of Korea (South Korea)

Important milestone paves way to increasing global access of Accrufer®

Pending successful review, approval in Korea anticipated in 2025

 

London, UK, 28 May 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 its Accrufer® partner for
Korea, Korea Pharma Co., Ltd (Korea Pharma) has submitted a New Drug
Application (NDA) to the Korean Ministry of Food and Drug Safety (MFDS) for
the review and approval of Accrufer® to treat patients with iron deficiency
anaemia in Korea. Pending a successful review, approval of Accrufer® in Korea
is anticipated in 2025.

 

Korea Pharma's MFDS filing follows the successful completion of a
pharmacokinetic (PK) study in Korea. The PK study confirms that the absorption
of iron from Accrufer® is comparable between patients in Korea and the
patient population enrolled in the key clinical studies supporting Accrufer®
effectiveness and safety.

 

Shield is eligible to receive a development milestone payment of c.$1.9 upon
the first sale of Accrufer® in the territory, as well as future commercial
sales milestone payments upon the achievement of specified net sales targets.
For the duration of the intellectual property, Shield will also receive
double-digit royalties on net sales of Accrufer® in Korea.  Shield will be
responsible for the initial manufacturing and supply to Korea Pharma.

 

Greg Madison, CEO of Shield, commented: "Iron deficiency anaemia is a global
issue. Shield is committed to working with valued partners, such as Korea
Pharma, to enable global access of Accrufer® and advance the care of patients
with iron deficiency anaemia around the world. Completion of the MFDS filing
by Korea Pharma marks the first filing for Accrufer® in Southeast Asia. We
are thrilled to work with our partner to reach this important milestone. We
look forward to supporting Korea Pharma as they continue the pathway to making
Accrufer® available to patients in Korea."

 

Eun-Hee Park, Korea Pharma CEO, commented: "We are pleased by the positive
results for the local PK study. These data enabled us to successfully complete
a regulatory filing for Accrufer® with the MFDS. There are an estimated 5.2
million people in the Republic of Korea with iron deficiency and iron
deficiency anaemia in need of novel treatment options. Pending approval of the
NDA, we look forward to providing Accrufer® to the people of Korea as a
potential first choice for the treatment of iron deficiency anaemia."

 

For further information please contact:

 

 Shield Therapeutics plc                                                                        www.shieldtherapeutics.com (http://www.shieldtherapeutics.com/)
 Greg Madison, 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/ George Dollemore/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)

 Investor Contact (US Advisor)

 LifeSci Advisors, LLC

 Joyce Allaire                                                                                  jallaire@lifesciadvisors.com (mailto:jallaire@lifesciadvisors.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.

 

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 Korea Pharma Co.,Ltd

Korea Pharma is a prescription pharmaceutical company focusing on CNS (central
nervous system) and GI (gastro-intestinal) products. Korea Pharma has
previously signed an exclusive distribution agreement With Norgine BV, a
global PEG-based bowel cleansing agent development company, for distribution
of PLENVU®, the world's first one-litre PEG (polyethylene glycol) bowel
preparation drug, and is developing a liquid type PEG laxative.

 

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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