TIDMSTX
RNS Number : 3169K
Shield Therapeutics PLC
13 December 2018
Shield Therapeutics plc
("Shield" or the "Group")
Shield Therapeutics announces the US New Drug Application PDUFA
date for Feraccru(R)
London, UK, 13 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
confirmed that the target date for completion of the New Drug
Application (NDA) review of Feraccru(R), under the terms of the
Prescription Drug User Fee Act (PDUFA), is 27 July 2019.
The United States, representing over a third of the global
pharmaceutical market, is a highly attractive opportunity for
Feraccru(R) and a market for which Shield retains full ownership
of, as well as complete control over, the global intellectual
property rights. Feraccru(R) is already approved in the European
Union for the treatment of iron deficiency in adults and, following
the recent licence agreement for Feraccru(R) in Europe, Norgine has
now commenced its own sales and marketing activities.
Carl Sterritt, Chief Executive Officer of Shield Therapeutics,
added: "Confirmation of the PDUFA date for completion of the review
of Feraccru(R) by the FDA is another important step towards being
able to offer Feraccru(R) to the very large pool of iron deficient
patients in the United States who would benefit from this novel new
treatment option. We will continue to work closely with the FDA to
achieve this goal, whilst also seeking an attractive commercial
partner for Feraccru in the USA who can help us realise the full
value of the opportunity that would be created by Feraccru's
approval."
- 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 absorption
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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