TIDMSTX
RNS Number : 7895G
Shield Therapeutics PLC
26 July 2019
The information contained within this announcement is deemed by
the Group to constitute inside information as stipulated under the
Market Abuse Regulation (EU) No. 596/2014. Upon the publication of
this announcement via the Regulatory Information Service, this
inside information is now considered to be in the public
domain.
Shield Therapeutics plc
("Shield" or the "Group")
FDA approves Feraccru(R) with a broad label of treating iron
deficiency in adults
Feraccru(R) to be marketed as Accrufer(R) in the USA
London, UK, 26 July 2019: Shield Therapeutics plc (LSE: STX), a
commercial stage, pharmaceutical company with a focus on addressing
iron deficiency, announces that the U.S. Food and Drug
Administration (FDA) has approved its lead product Feraccru(R) /
Accrufer(R) for the treatment of iron deficiency in adults.
With this broad label approval Accrufer(R) (as the product will
be marketed in the USA) has taken a big step towards exploiting the
very large commercial opportunity in the USA, the world's largest
and most attractively reimbursed pharmaceutical market. Market
research suggests that the prescription market for iron replacement
therapy in the USA is worth over $1.0bn annually. There are between
8 million and 9 million patients in the USA who suffer from iron
deficiency anaemia and management estimate potentially two to three
times this number require treatment for iron deficiency.
Accrufer(R)'s confirmed efficacy, together with its good
tolerability and mode of absorption - by which the body absorbs
only as much iron from Accrufer(R) as it needs - means that the
product could be the ideal choice for iron deficient patients who
cannot tolerate salt-based oral iron alternatives. These features,
combined with the non-inferiority results from the AEGIS-H2H study
announced in March 2019, mean that treatment with Accrufer(R) might
remove the need for patients to progress to intravenous iron
therapy, leading to a change in the current paradigm for the
treatment of iron deficiency anaemia.
Together with its advisors, Shield is in discussions with a
number of potential commercial partners for the US opportunity for
Accrufer(R) and looks forward to providing updates on these
discussions in due course.
Feraccru(R) is already approved in both the European Union and
Switzerland for the treatment of iron deficiency in adults and
commercialisation activities in these territories are progressing
well via Shield's licensing partners.
Carl Sterritt, CEO of Shield Therapeutics: "We are delighted
that the FDA has approved the new drug application for our lead
asset. This is a further major milestone for the Company which we
have worked tirelessly to achieve, and I am very proud to lead the
team within Shield that has made this happen. With this broad
approval and IP protection out to 2035, Feraccru(R)/ Accrufer(R)
has a real and very attractive long-term market opportunity to
exploit in the USA. We have been pleased with the levels of
interest and engagement shown by 3(rd) parties in commercialising
Accrufer(R) in the USA and we look forward to finalising these
discussions and appointing a commercial partner In the world's most
attractive pharmaceutical market, so that more patients with iron
deficiency can benefit from treatment with Accrufer(R) at the
earliest opportunity."
Jackie Mitchell, VP Regulatory Affairs of Shield Therapeutics:
"The broad label that the FDA has granted provides a very strong
signal as to the tolerability and efficacy profile of Feraccru(R)/
Accrufer(R) and provides a novel and convenient treatment
alternative to the millions of US patients who routinely suffer
with iron deficiency. We believe that this broad approval, together
with the recent clinical trial data on Feraccru(R) that showed it
to be non-inferior in treatment effect to Ferinject(R)/
Injectafer(R), the leading IV iron therapy, can lead to a change in
the current paradigm for the treatment iron deficiency
anaemia."
The person who arranged for the release of this announcement on
behalf of Shield Therapeutics plc was Carl Sterritt, Chief
Executive Officer.
For further information please contact:
Shield Therapeutics plc www.shieldtherapeutics.com
Carl Sterritt, Chief Executive
Officer +44 (0)20 7186 8500
Tim Watts, Chief Financial
Officer
Nominated Advisor and Broker
Peel Hunt LLP
James Steel/Dr Christopher
Golden +44 (0)20 7418 8900
Joint Broker
finnCap Ltd
Geoff Nash/Matt Radley/Alice
Lane +44 (0)20 7220 0500
Financial PR & IR Advisor
Walbrook PR +44 (0)20 7933 8780 or shield@walbrookpr.com
+44 (0)7980 541 893 / +44 (0)7584 391
Paul McManus / Lianne Cawthorne 303
About Shield Therapeutics plc
Shield is a de-risked, commercial stage, specialty
pharmaceutical company delivering innovative pharmaceuticals to
address patients' unmet medical needs. The Company's clear purpose
is to help its patients become people again, by enabling them to
enjoy the things that make the difference in their everyday lives.
The Group has a marketed product, Feraccru(R) / Accrufer(R), for
the treatment of iron deficiency in adults which has exclusive IP
rights until the mid-2030s. Feraccru(R) / Accrufer(R), is approved
by the FDA, EMA and Swiss Medic for the treatment of iron
deficiency in adults and is commercialised in the European Union by
Norgine BV, with a US commercialisation partner currently being
selected. For more information please visit
www.shieldtherapeutics.com.
About Feraccru(R)/ Accrufer(R)
Feraccru(R)/ Accrufer(R) is a novel, stable, non-salt based oral
treatment for adults with iron deficiency with or that has been
shown to be an efficacious and well-tolerated therapy in a range of
controlled phase 3 trials. Following the recently announced
positive results of the Phase IIIb AEGIS-H2H study in which
Feraccru(R)demonstrated it was non-inferior to
intravenously-administered Ferinject(R) at delivering improvements
in haemoglobin levels without requiring hospital-based
administration, Feraccru(R)/ Accrufer(R) offers a compelling
alternative to IV Iron for those patients that cannot tolerate
salt-based oral iron therapies and wish to avoid the complexities
of infusion-based therapies.
When salt-based oral iron therapies are ingested they can cause
a range of mild-to-severe gastrointestinal tract (GI) adverse
events, including nausea, bloating and constipation. These lead to
poor tolerability, reduced patient compliance and ultimately
treatment failure. Feraccru(R)/ Accrufer(R) is not an iron salt;
iron can be absorbed from the ferric maltol molecule and, as a
result, it does not routinely cause the same treatment-limiting
intolerance issues.
Prior to Feraccru(R)/ Accrufer(R), IV iron therapies were the
only realistic alternative treatment option for patients intolerant
of or unwilling to take salt-based oral iron therapies. However,
use of such an invasive, costly, inconvenient and complex to
administer treatment option, which is associated with potentially
life-threatening and spontaneous hypersensitivity reactions, means
there remains a clear unmet medical need for patients with iron
deficiency to have access to an effective therapy like Feraccru(R)/
Accrufer(R) that is well tolerated, convenient and does not require
hospital-based administration.
About Iron Deficiency
The WHO state that iron deficiency is the most common and
widespread nutritional disorder in the world. As well as affecting
a large number of children and women in non-industrialized
countries, it is the only nutrient deficiency which is also
significantly prevalent in virtually all industrialized nations.
There are no current global figures for iron deficiency, but using
anaemia as an indirect indicator it can be estimated that most
preschool children and pregnant women in non-industrialized
countries, and at least 30-40% in industrialized countries, are
iron deficient.
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 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, 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 Group'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 Group disclaims any obligation to
update any forward-looking statements contained in this release,
even if subsequent events cause our views to change.
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London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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