Shield Therapeutics PLC KYE Pharmaceuticals Files Accrufer(R) NDS in Canada (3313F)
21 Marzo 2022 - 01:00AM
UK Regulatory
TIDMSTX
RNS Number : 3313F
Shield Therapeutics PLC
21 March 2022
Shield Therapeutics plc
("Shield" or the "Company" or the "Group")
KYE Pharmaceuticals Inc. Files Accrufer(R) New Drug Submission
in Canada for the Treatment of Iron Deficiency
London, UK - 21 March 2022: Shield Therapeutics plc (LSE: STX),
a commercial stage pharmaceutical company with a focus on treating
iron deficiency with its lead product Accrufer(R)/Feraccru(R)
(ferric maltol), announces that KYE Pharmaceuticals Inc. ('KYE')
has submitted a New Drug Submission ('NDS') to Health Canada for
the regulatory review and approval of Accrufer(R).
If approved, Accrufer(R) would be the first prescription only
oral iron therapy approved by Health Canada. Marketing approval for
Accrufer(R) is expected to be during 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 2022. Both
organisations have demonstrated excellent collaboration and are
driven to make Accrufer(R) available to patients in Canada with
iron deficiency as quickly as possible. Shield Therapeutics is
committed in bringing Accrufer(R)/Feraccru(R) to patients with iron
deficiency around the world, and Canada is an important element of
that mission."
Shield is eligible to receive GBP850,000 in development and
sales milestones comprised of a payment of GBP250,000 upon
regulatory approval of Accrufer(R) by Health Canada and up to
GBP600,000 in milestone payments upon the achievement of specified
calendar net sales targets. For the term of the agreement, Shield
will also receive double-digit royalties on net sales of
Accrufer(R).
For further information please contact:
Shield Therapeutics plc www.shieldtherapeutics.com
Greg Madison, CEO +44 (0) 191 511 8500
Hans-Peter Rudolf, CFO
Nominated Adviser and Joint
Broker
Peel Hunt LLP
James Steel/Christopher Golden +44 (0)20 7418 8900
Joint Broker
finnCap Ltd
Geoff Nash/ George Dollemore/Alice
Lane/Nigel Birks +44 (0)20 7220 0500
Financial PR & IR Advisor
Walbrook PR
Lianne Applegarth/Alice Woodings +44 (0)20 7933 8780 or shield@walbrookpr.com
Investor Contact (US Advisor)
LifeSci Advisors, LLC
John Mullaly +1 617 429 3548 or jmullaly@lifesciadvisors.com
About Accrufer (R) /Feraccru (R)
Accrufer(R)/Feraccru(R) (ferric maltol) is a novel, stable,
non-salt based oral therapy for adults with iron deficiency, with
or without anemia. Accrufer(R)/Feraccru(R) 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(R)/ Feraccru(R) ,
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
with a focus on addressing iron deficiency with its lead product
Accrufer(R)/Feraccru(R) (ferric maltol). The Group has launched
Accrufer(R) in the US and Feraccru(R) is commercialised 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 commercialisation of Accrufer(R) /
Feraccru(R) 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(R)/Feraccru(R) has patent coverage until the
mid-2030s.
Accrufer(R)/Feraccru(R) are registered trademarks of the Shield
Group.
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