Important New Trial With Oral FERACCRU® Shows Comparable Efficacy to IV Iron (Ferric Carboxymaltose), Offering a Real Alternative to Hospital Administration for Many Patients[4]

Amsterdam (ots/PRNewswire) -

- FERACCRU® (Ferric Maltol) met primary endpoint against Ferinject®
(IV Ferric Carboxymaltose (FCM)) and shows clear benefits to Iron
Deficiency Anaemia (IDA) patients with inactive Inflammatory Bowel
Disease (IBD)4
- FERACCRU® delivered a haemoglobin (Hb) response rate at 12 weeks
that was within 9% of the effect seen with a market leading IV iron
treatment (IVI FCM), but without the need for hospital-based
administration4
- FERACCRU® was efficiently absorbed and well tolerated over the
extended treatment period, in line with previous studies2

Shield Therapeutics plc (Shield) and Norgine B.V. (Norgine) today
announced positive results from the AEGIS Head-to-Head (H2H) clinical
trial, which compared FERACCRU® (ferric maltol), a novel oral iron
replacement therapy, to Ferinject® (ferric carboxymaltose (FCM)), a
market-leading intravenously delivered iron replacement therapy4.

In the AEGIS-H2H study, ferric maltol demonstrated increases in
the mean Hb levels that were comparable to IV FCM. Patients with Iron
Deficiency Anaemia (IDA), whose Inflammatory Bowel Disease (IBD) is
inactive now have an important alternative treatment option, which is
both effective over the long term and well tolerated, therefore
reducing the need for time-consuming and expensive hospital
administration. Current oral iron treatments can be poorly tolerated
and don't always work7, which leads to many unwell patients having to
receive IV iron in hospital.

"The results of this study provide an important opportunity to
change clinical practice to improve patients' lives. Patients with
inactive Inflammatory Bowel Disease who are unwell as a result of
Iron Deficiency Anaemia have often tried a number of oral iron
treatments which didn't work or they couldn't tolerate," commented Dr
Alastair Benbow, Chief Medical and Development Officer at Norgine.
"Previously, they would have needed to go to hospital for
time-consuming and expensive IV administration. Now many patients can
be treated at home with an effective and well-tolerated oral iron
alternative," he added.

More detailed analyses of the data, including the secondary
endpoints and safety parameters, will be presented at Shield's
upcoming presentation of its preliminary results for 2018, scheduled
for early April 2019, whilst the full data will be submitted for
peer-review and subsequent presentation by the study's lead
investigators at upcoming scientific meetings.

FERACCRU® is a novel, effective and well tolerated treatment,
which is approved and marketed in the European Union for the
treatment of iron deficiency (ID) in adults and in Switzerland for
the treatment of iron deficiency anaemia (IDA) in adults with
inflammatory bowel disease (IBD) 1-3. A New Drug Application in the
USA is being reviewed by the FDA with a PDUFA date of 27 July 2019.

On 19 September 2018, Norgine entered into an exclusive licence
agreement with Shield Therapeutics plc for the commercialisation of
the product in Europe, Australia and New Zealand.

www.norgine.com

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Notes to Editors:

About IDA in IBD

Iron deficiency anaemia (IDA) is frequently seen in inflammatory
bowel disease (IBD). Characteristic symptoms of anaemia include
chronic fatigue, headache, and subtle impairment of cognitive
function.

IDA is difficult to treat, partly because many patients are
intolerant to traditional oral iron therapies5. Currently, the only
treatment option for IDA patients who cannot tolerate oral iron
therapies is IV iron therapy. IV iron therapies, however, can be time
and resource consuming to administer. They may also come with
potentially life-threatening, spontaneous hypersensitivity
reactions6.

In the AEGIS-H2H study, ferric maltol demonstrated increases in
Hb levels that were comparable to IV FCM and now offers an important
alternative option for these patients, maintaining efficacy with good
tolerability, without the need for hospital administration4.

About the AEGIS Head-to-Head (H2H) study

The 52 week AEGIS-H2H Phase 3b study compared the efficacy of oral
ferric maltol to IVI FCM in the treatment and maintenance of IDA in
subjects with inactive IBD in whom other oral iron therapies had
failed4.

This was a multi-national Phase IIIb randomised, active-controlled
trial in 242 patients across USA and Europe with haemoglobin (Hb)
measurements as low as 8.0g/dL. The objective of the study was to
assess whether the effect of ferric maltol on Hb levels (defined by
the protocol as normalisation of Hb or a >2g/dL rise in Hb from
baseline) was comparable to the effect seen with IVI FCM treatment at
12 weeks. This was followed by a 40-week extension phase, during
which eligible subjects continued treatment with ferric maltol or
received IVI FCM in line with clinical need as described in IVI FCM's
Summary of Product Characteristics in the EU and its Prescribing
Information in the USA.

Primary analysis of the AEGIS-H2H dataset has shown that the Hb
response rate to ferric maltol was within 9% of the response rate
seen with FCM, and comparable to the increase observed in the
original AEGIS-IBD study2. The primary endpoint of the study was
defined as the Lower Confidence Limits being less than 20% different
for ferric maltol versus IVI FCM and statistical analysis of this
endpoint provides a positive p value of 0.0224.

Secondary endpoints included assessment of Hb response to both
therapies and measurement of key iron storage parameters through 52
weeks as well as the usual safety assessments.

For further information about the trial, including inclusion and
exclusion criteria, please contact us.

About FERACCRU®

Ferric maltol is a novel oral ferric iron therapy for the
treatment of iron deficiency (ID) in adults. The recommended dose is
one capsule (30mg) taken twice a day, morning and evening, on an
empty stomach. Treatment duration depends on the severity of the iron
deficiency (ID), but generally at least 12 weeks of treatment are
required. Ferric maltol normalises and maintains Hb levels, limiting
the need for intravenous (IV) iron treatment to patients with Hb
levels <9.5g/dl1.

In the original Phase III AEGIS IBD clinical trial programme,
which led to the license being granted, the efficacy and tolerability
of ferric maltol was assessed in the treatment of IDA in patients
with inactive IBD versus placebo, who had previously failed to
respond, or had been intolerant to previous oral ferrous products
(OFP). Ferric maltol was shown to be effective and well-tolerated at
both 12 and 64 weeks2.

About Norgine

Norgine is a leading European specialist pharmaceutical company
with a direct commercial presence in all major European markets.
Norgine specialises in gastroenterology, hepatology, cancer and
supportive care. In 2017, Norgine's total net product sales were EUR
345 million, up 17 per cent.

Norgine employs over 1,000 people across its commercial,
development and manufacturing operations and manages all aspects of
product development, production, marketing, sale and supply.

For more information, please visit www.norgine.com

In 2012, Norgine established a complementary business Norgine
Ventures, supporting innovative healthcare companies through the
provision of debt-like financing in Europe and the US. For more
information, please visit www.norgineventures.com.

NORGINE and the sail logo are trademarks of the Norgine group of
companies.

About Shield Therapeutics plc

Shield is a de-risked, commercial stage, pharmaceutical company
delivering innovative specialty 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®, for the treatment of iron deficiency in
adults which has exclusive IP rights until the mid-2030s. Feraccru®
is commercialised in the European Union by Norgine BV and the US Food
and Drug Administration (FDA) is currently considering a New Drug
Application (NDA), with a PDUFA (Prescription Drug User Fee Act) date
of 27th July 2019. For more information please visit
www.shieldtherapeutics.com.

References

1. Summary of Product Characteristics, Shield Pharmaceuticals March
2018. Available at:
https://www.medicines.org.uk/emc/medicine/31722 Accessed March
2019
2. Gasche C, et al. Inflamm Bowel dis 2015; 21 (3): 579-588 Available
at https://www.ncbi.nlm.nih.gov/pubmed/25545376 Accessed March
2019
3. Schmidt C, et al. Aliment Pharmacol Ther 2016;44 (3): 259-270
Available at https://www.ncbi.nlm.nih.gov/pubmed/27237709 Accessed
March 2019
4. Shield Study ST10-01-304 Headline Results 4th March 2019: "A phase
3b, randomized, controlled, multicentre study with oral ferric
maltol or intravenous ferric carboxymaltose, for the treatment of
iron deficiency anaemia in subjects with inflammatory bowel
disease"
5. Biancone et al. J Crohn's and Colitis 2008; 2: 63-92.
6. Ferinject SmPC November 2018 https://www.medicines.org.uk/emc/prod
uct/5910/smpc#CLINICAL_PRECAUTIONS
7. Lugg et al. 2014 Journal of Crohn's and Colitis 8, 876-880

Date of preparation March 2019

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ots Originaltext: Norgine
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Contact:
Clara Bentham +44 (0)1895 826654 or +44 (0)7734 367883
Eleni Fistikaki +44 (0)1895826227 or +44 (0)7825389477
contact@norgine.com

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