TIDMSTX
RNS Number : 1448J
Shield Therapeutics PLC
03 December 2018
Shield Therapeutics plc
("Shield" or the "Group")
Shield Therapeutics announces the New Drug Application for
Feraccru(R) has been accepted for filing and review by the FDA
London, UK, 3(rd) December 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 US Food and Drug
Administration (FDA) has accepted for review the New Drug
Application (NDA) for Feraccru(R), Shield's lead product. Under the
terms of the Prescription Drug User Fee Act (PDUFA), the FDA will
shortly confirm to Shield the expected target date in 2019 for
completion of the NDA review and Shield will provide a further
update at that time.
Feraccru(R) is already approved in the European Union for the
treatment of iron deficiency in adults and in Switzerland for the
treatment of iron deficiency anaemia in adults with inflammatory
bowel disease. The United States, representing over a third of the
global pharmaceutical market, is a highly attractive opportunity
for Feraccru(R) and a market which Shield retains full ownership
of, as well as complete control of the global intellectual property
rights.
In September 2018, Feraccru(R) was licensed to Norgine B.V. in
all European territories not already partnered as well as Australia
and New Zealand. In return Norgine B.V. paid a licence fee of
GBP11m, with scope for additional milestones totalling EUR54.5m and
royalties on sales ranging from 25% up to 40%.
Commenting on the announcement, Dr Jackie Mitchell, VP of
Regulatory Affairs and Quality at Shield Therapeutics, said: "We
are delighted to have achieved this key regulatory milestone in
widening Feraccru's geographical availability for patients
suffering from iron deficiency. We look forward to interacting
positively with the FDA over the coming months and, if approved,
Feraccru will provide a novel and much needed treatment option for
patients with iron deficiency."
Carl Sterritt, Chief Executive Officer of Shield Therapeutics,
added: "News that the NDA has been validated and accepted for
review by the FDA brings us a major step closer to Feraccru
potentially being approved in the USA in 2019. Following the
licensing agreement we signed with Norgine in September for the
commercialisation of Feraccru in Europe, Australia and New Zealand,
we are well-funded and are increasingly excited about Feraccru's
future as we continue to enact our plans to realise the value
creation opportunities that lie ahead for Shield and its
shareholders ."
- Ends -
For further information please contact:
Shield Therapeutics plc +44 (0)207 186 8500
Carl Sterritt, Chief Executive Officer
Tim Watts, Interim Chief Financial Officer
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 +44 (0)203 709 5700
Consilium Strategic Communications
Mary-Jane Elliott/Matthew Neal
About Feraccru(R)
Feraccru(R) 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(R) is not an iron salt, and 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(R)
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(R). 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 iron deficiency in adult
patients with or without anaemia. Feraccru(R) 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 news service of the
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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