TIDMSTX
RNS Number : 8217F
Shield Therapeutics PLC
23 February 2018
Shield Therapeutics plc
("Shield" or the "Group")
Shield receives CHMP positive opinion for Feraccru(R) (Ferric
Maltol) for the treatment of Iron Deficiency in adults
Recommendation for broad label in EU
London, UK, 23 February 2018: Shield Therapeutics plc (LSE:STX),
a commercial stage, pharmaceutical company delivering innovative
specialty pharmaceuticals to address patients' unmet medical needs,
with an initial focus on addressing iron deficiency anaemia, today
announces that the Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency (EMA) has adopted a
positive opinion for the marketing authorisation approval of
Feraccru (Ferric Maltol) to be extended to include treatment of all
adults with iron deficiency (ID) with or without anaemia, which
will provide Feraccru with a much broader commercial opportunity.
This recommendation will now go forward to the European Commission
for ratification and implementation over the next two to three
months. Feraccru, the Company's lead asset, is currently approved
and marketed in Europe for the treatment of iron deficiency anemia
(IDA), initially in patients with inflammatory bowel disease
(IBD).
Dr Mark Sampson, Chief Medical Officer of Shield Therapeutics,
said: "We are pleased to receive this positive opinion from the
CHMP for Feraccru and it is an important step for Shield and for
patients suffering with iron deficiency be that with or without
anaemia. Iron deficiency causes significant morbidity and failure
to be able to treat it adequately with current therapies can cause
the disease to progress to iron deficiency anaemia. The WHO has
identified that iron deficiency is a globally important health
issue significantly impacting the lives up to 2 billion
people."
Carl Sterritt, Chief Executive Officer of Shield Therapeutics,
said: "As we announced yesterday, the Board has initiated a
complete review of the various strategic options available to the
Company, particularly the options for Feraccru to deliver
significant value to shareholders. Once this recommendation is
ratified by the European Commission in the near term, the market
opportunity for Feraccru in Europe significantly expands from the
current 300,000 patients with IDA in IBD, to a much broader patient
population opportunity, with over 40 million* people in the EU
estimated to be iron deficient. With Feraccru being protected by a
composition of matter patent through to 2035, this a valuable step
forward for the Company as it considers its strategic options. We
look forward to the European Commission's ratification and approval
of the CHMP's positive opinion."
The positive opinion from the CHMP will now be reviewed by the
European Commission, which has the authority to approve medicines
for use in the 28 EU member countries, Iceland, Norway and
Liechtenstein. The EC generally follows the recommendation of the
CHMP two to three months following CHMP opinion.
*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 plasma, iron is carried tightly bound to the
protein transferrin. There are several mechanisms that control
human iron metabolism and safeguard against iron deficiency. The
main regulatory mechanism is 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 hemoglobin in your red blood cells (RBCs). Hemoglobin is
the protein in your RBCs that is responsible for carrying oxygen to
your tissues. Iron deficiency anemia is the most common type of
anemia, and it occurs when your body doesn't have enough of the
mineral iron. Your body needs iron to make hemoglobin. When there
isn't enough iron in your blood stream, the rest of your body can't
get the amount of oxygen it needs. While the condition may be
common, many people don't know they have iron deficiency anemia.
It's 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 13g/dL and in women anemia is typically defined as having
an HB level of less than 12.0 g/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, and 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 IDA.
This free iron readily chelates to form insoluble clumps and
produces 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 with IDA 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, and iron
can be absorbed from the ferric maltol molecule, 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 IDA patients 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 and 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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