TIDMSTX
RNS Number : 0319J
Shield Therapeutics PLC
27 March 2018
Shield Therapeutics plc
("Shield" or the "Group")
Shield receives EU Commission approval for the broadening of the
indication for Feraccru(R) (Ferric Maltol) to the treatment of Iron
Deficiency in adults
London, UK, 27 March 2018: Shield Therapeutics plc (LSE:STX), a
commercial stage, pharmaceutical company delivering innovative
specialty pharmaceuticals to address patients' unmet medical needs,
today announces that the European Commission (EC) has adopted the
Decision to extend the approved indication for Feraccru to include
treatment of all adults with iron deficiency (ID) with or without
anaemia.
This decision, which follows the recent positive opinion of the
Committee for Human Medicinal Products (CHMP) of the European
Medicines Agency (EMA) to adopt this extension of Feraccru's
marketing authorisation approval, will provide Feraccru with a much
broader commercial opportunity, as previously it was only approved
and marketed in Europe for the treatment of iron deficiency anemia
(IDA) in adult patients with inflammatory bowel disease (IBD).
Carl Sterritt, Chief Executive Officer of Shield Therapeutics,
said: "We are extremely pleased that following the CHMP positive
opinion in February, the EU Commission has so rapidly ratified the
expansion of the indication for Feraccru. This decision confirms a
significantly broader patient population target opportunity for
Feraccru in Europe, where 40 million* people are estimated to be
iron deficient."
The European Commission approval governs the marketing of
Feraccru in all 28 EU member countries, as well as Iceland, Norway
and Liechtenstein.
*Levi, M., Rosselli, M., Simonetti, M., Brignoli, O., Cancian,
M., Masotti, A., Pegoraro, V., Cataldo, N., Heiman, F., Chelo, M.,
Cricelli, I., Cricelli, C. and Lapi, F. (2016), Epidemiology of
iron deficiency anaemia in four European countries: a
population-based study in primary care. Eur J Haematol, 97:
583-593. doi:10.1111/ejh.12776
Other Feraccru pipeline events:
Feraccru AEGIS-H2H non-inferiority EU Phase 3b study
The AEGIS-H2H Phase 3b study is designed as a non-inferiority
trial comparing the efficacy and safety of Feraccru to the
market-leading latest generation form of IV iron
(Ferinject/Injectafer, ferric carboxymaltose). Primary endpoint
data from the AEGIS-H2H study is expected to be available in the
second half of 2018.
- Ends -
For further information please contact:
Shield Therapeutics plc +44 (0)207 186 8500
Carl Sterritt, Chief Executive Officer
Dr Karl Keegan, Chief Financial Officer
Fleur Wood, Director, Investor Relations
Nominated Advisor and Joint Broker
+44 (0)203 100 2222
Liberum Capital Limited
Christopher Britton/Steve Pearce
Joint Broker
+44 (0)207 418 8900
Peel Hunt LLP
James Steel/ Dr Christopher Golden
Financial PR Advisor
+44 (0)203 709 5700
Consilium Strategic Communications
Mary-Jane Elliott/Matthew Neal
About Iron Deficiency, Anemia and Iron Deficiency Anemia:
Iron deficiency occurs when a body does not have enough iron to
supply its needs. Iron is present in all cells in the human body
and has several vital functions, such as: carrying oxygen to the
tissues from the lungs as a key component of the hemoglobin
protein; acting as a transport medium for electrons within the
cells in the form of cytochromes; facilitating oxygen enzyme
reactions in various tissues. Before iron deficiency causes anaemia
the iron stores in the reticuloendothelial system must be
completely depleted, leading to symptoms including fatigue,
irritability, lack of concentration, hair loss, brittle nails and
impaired immune function. Many women in the reproductive age group
have very limited or no storage iron due to menstrual blood
loss.
Total body iron averages approximately 3.8g in men and 2.3g in
women. In blood iron is carried tightly bound to the protein
transferrin. There are several mechanisms that control human iron
metabolism and safeguard against iron deficiency with the main
regulatory mechanism situated in the gastrointestinal tract.
Untreated iron deficiency can lead to iron deficiency anemia, a
common type of anemia. Anemia occurs when you have a decreased
level of haemoglobin (Hb) in your red blood cells (RBCs).
Haemoglobin is the protein in RBCs that is responsible for carrying
oxygen to tissues. Iron deficiency anemia is the most common type
of anemia, and it occurs when the body doesn't have enough iron as
the body needs iron to make haemoglobin. When there isn't enough
iron in the blood, the rest of the body cannot get the amount of
oxygen it needs. While the condition can be common, many people
don't know they have iron deficiency anemia and it is possible to
experience the symptoms for years without ever knowing the
cause.
For men, anemia is typically defined as having an Hb level of
less than 13.0g/dL and in women anemia is typically defined as
having an Hb level of less than 12.0g/dL.
The primary causes of IDA are inadequate dietary iron, excess
loss of iron usually attributable to some form of bleeding and loss
of red blood cells or reduced iron absorption, most commonly due to
chronic inflammation caused by a significant disease such as IBD,
CKD congestive heart failure and cancer. IDA commonly causes rapid
heartbeat, chest pain, diminished cognitive function, depression,
fatigue, trouble breathing, dizziness, headache, inability to
concentrate, light-headedness, difficulty staying warm and loss of
sex drive. Severe IDA, if untreated, can ultimately lead to
death.
About Feraccru(R)
Feraccru is a novel, stable, non-salt, oral formulation of
ferric iron, which has a differentiated mechanism of action
compared to salt-based oral iron therapies. When salt-based oral
iron therapies are ingested, the iron must dissociate from the salt
in the GI tract to allow the iron to be absorbed and treat the iron
deficiency or the anaemia. This free iron readily chelates to form
insoluble clumps as well as producing damaging free radicals that
together cause a range of mild-to-severe GI adverse events
including nausea, bloating and constipation; leading to poor
tolerability, reduced patient compliance and ultimately treatment
failure. In addition, many patients are concurrently treated with
medicines that raise the pH in the gut, which further reduces the
effect of salt-based oral iron therapies as they require highly
acidic conditions to be absorbed. Feraccru 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. Feraccru has been shown in clinical trials to
be well-tolerated by patients even when they had previously failed
treatment with salt-based oral iron therapies, which should lead to
increased patient compliance and better patient outcomes.
Currently, the only treatment option for patients with iron
deficiency with or without anaemia who cannot tolerate salt-based
oral iron therapies, is IV iron therapy. IV iron therapies quickly
increase iron stores via direct administration of very large doses
of iron, causing an increase in Hb levels that is physiologically
controlled and occurs over a period of weeks, as is the case with
Feraccru. IV iron therapies, however, are invasive, costly,
inconvenient, complex to administer and also come with potentially
life-threatening, spontaneous hypersensitivity reactions.
About Shield Therapeutics plc
Shield is a commercial stage, pharmaceutical company delivering
innovative specialty pharmaceuticals to address patients' unmet
medical needs. Our clear purpose is to help our 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), for the treatment of IDA in adult patients
with IBD which has exclusive IP rights until the mid-2030's. For
more information please visit www.shieldtherapeutics.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 timing of future results of Feraccru trials and the timing and
success of the Group's regulatory plans and 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 regulatory approval process, 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.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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