New Data Show Oral Ferric Maltol (FERACCRU®) May Be a Cost-effective Alternative to Intravenous (IV) Carboxymaltose With at Least as Great Benefits in the Quality of Life of Patients With Iron Deficie

Amsterdam (ots/PRNewswire) - - Ferric maltol (FM) was associated with
substantially lower use of healthcare resources than IV ferric carboxymaltose
(FCM)

- IV FCMwas linked to greater productivity loss and disruption to patients' work
and family life due to the need for clinic-based IV administration

- 50% of patients on IV FCM lost at least one full day due to treatment with 43%
losing up to EUR387.51, as quantified for a German setting

- Mean total per patient drug costs were approximately 1.6 times higher for
treatment with IV FCM compared to FM

Norgine B.V. highlighted new data from three post hoc analyses of the randomised
controlled, open label, phase 3b non-inferiority study of oral ferric maltol vs
intravenous ferric carboxymaltose (NCT02680756), presented at the 15th European
Crohn's and Colitis Organisation (ECCO) Congress in Vienna. Ferric maltol, a
novel oral iron replacement therapy, was found to be a cost-saving alternative
to intravenous (IV) ferric carboxymaltose (FCM) by reducing drug administration
costs[1] and productivity loss,[2] with at least as great benefit to the
health-related quality of life (HRQoL) of patients with iron deficiency anaemia
(IDA) and inflammatory bowel disease (IBD).[3]

Dr. Stefanie Howaldt from the Hamburg Research Institute for IBD, HaFCED e.K.,
Germany presented the new research findings at ECCO and commented, "Iron
deficiency anaemia is very common in inflammatory bowel disease and can
significantly impair the quality of life of patients. Due to very common
intolerance to standard oral iron products, IV iron is currently the main
treatment alternative for IBD patients with IDA. These new data demonstrate that
ferric maltol is not only a well-tolerated and effective therapy, which we
previously knew, but also a cost-saving treatment for the healthcare system,
representing an alternative oral treatment option with substantial
health-related quality of life benefit for IBD patients with IDA.''

IDA can be a serious complication of IBD resulting from inflammation, chronic
mucosal blood loss and iron malabsorption.[4] Treatment of IDA involves
iron-replacement therapy often with oral iron supplementation in the first
instance.[4] However, use of oral ferrous iron medications may be limited by
poor absorption and adverse events[4,5] which can lead to many unwell patients
having to receive IV iron in hospital.

Patient-reported outcomes are an important way to measure health and wellbeing.
Measures of HRQoL in IDA have the potential to reflect both IDA symptoms and
treatment-related issues such as adverse effects, so are a useful tool to
capture additional treatment benefits beyond those typically reported in
clinical studies.[3]

In the quality of life post hoc analysis, the HRQoL benefits of FM and IV FCM
and their relationship to haematological parameters were analysed using data
from a randomised controlled trial. The analysis showed that improvements in
SF-36 PCS and MCS scores were slightly greater with FM than with IV FCM
(difference not statistically significant). FM patients experienced at least as
great benefit in all SF-36 domains such as general and mental health, bodily
pain, vitality, physical, social and emotional functioning.[3]

IDA imposes a substantial economic burden on the healthcare payer system
resulting primarily from increased medical costs and hospital admissions. The
second post hoc analysis looked at the impact on productivity comparing the
associated productivity loss of oral FM vs. IV FCM. The study found that 50% of
patients treated with IV FCM lost at least one full day due to treatment, with 1
in 15 losing 4-6 days. Productivity loss was quantified, with IV FCM treatment
associated with losses between EUR0.00 and EUR107.21 in 50% of patients,
EUR129.17 and EUR387.51 in 43% of patients and EUR516.68 and EUR775.02 in 7% of
patients. As FM was administered orally by the patient and did not require any
in-hospital treatment administration, there was no treatment linked productivity
loss. FM did not have the indirect costs associated with IV FCM and as such may
provide an oral alternative to IV iron in patients with IBD, enabling them to
avoid the disruption of everyday life activities due to the need for in-hospital
IV administration.[2]

The third post hoc analysis compared the health care resource use (HCRU)
associated with oral FM and IV FCM. The data showed that total per patient drug
costs (acquisition and administration) were approximately 1.6 times higher for
treatment with IV FCM than FM. The total cost of IV FCM is not only influenced
by the higher drug cost, but additional costs associated with IV administration
which was required to be carried out in a hospital or outpatient setting. FM has
no additional costs or resource use associated with administration and is
therefore less of a burden on local health care systems. [1]

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Notes to Editors:

About the post hoc analyses

Patients with IBD and IDA (haemoglobin [Hb] >=8.0 g/dL and <=11.0 g/dL for women
or >=8.0 g/dL and <=12.0 g/dL for men, and ferritin <30 ng/mL or ferritin <100
ng/mL with transferrin saturation <20%) were randomised to FM (30 mg b.d.) or IV
FCM (as per local Summary of Product Characteristics [SmPC] or prescribing
information) in an open-label, Phase 3b non-inferiority study. The primary
endpoint was Hb responder rate (proportion of patients achieving a >=2 g/dL
increase or normalisation of Hb at week 12). 250 patients were randomised: 125
to FM (per-protocol [PP] n=86) and 125 to IV FCM (PP n=93). The Hb responder
rate for oral FM was non-inferior to IV FCM in the PP population (74% vs 83%);
risk difference was -0.1 (two-sided p=0.017; 95% CI -0.2, 0.0), within the
pre-defined non-inferiority margin of 20% difference.

For the post hoc analysis 'Impact of oral ferric maltol and IV iron on
health-related quality of life in patients with iron deficiency anaemia and
inflammatory bowel disease, and relationship with haemoglobin and serum iron',
patients with IBD and IDA were randomised to FM (30 mg b.d) or IV FCM (as per
local SmPC) with primary endpoint Hb responder rate [proportion of patients with
>=2 g/dL increase or normalisation of Hb at week 12; non-inferiority margin
20%]. HRQoL was assessed via the Short Form Health Survey (SF-36). In the post
hoc analysis of patient-level data, Hb, serum iron and HRQoL at baseline and
week 12 were summarised descriptively and correlations between HRQoL and
haematological parameters were assessed via Pearson's correlation coefficient
(PCC). Hb, serum iron and HRQoL all improved following both treatments at Week
12. Improvements in SF-36 physical component summary (PCS) and mental component
summary (MCS) scores were slightly greater with FM (difference not statistically
significant). HRQoL improved across all SF-36 domain scores with both FM and
FCM, with no statistically significant differences between treatments. HRQoL
(MCS and PCS) improvements were positively associated with increases in Hb and
serum iron. [3]

For the post hoc analysis 'Productivity loss in patients with inflammatory bowel
disease receiving treatment for iron deficiency anaemia: a comparison of ferric
maltol and IV iron' Productivity loss was calculated based on the number of days
lost due to iron therapy during the initial 12-week study period. The costs
associated with lost productivity were calculated using the human capital
approach and based on the average gross income from Germany. IV FCM treatment
resulted in a loss of patient time because IV administration was limited to an
outpatient setting: 50% of patients treated with IV FCM lost at least one full
day due to treatment, with 1 in 15 losing 4-6 days. Productivity loss was
quantified, with IV FCM treatment associated with losses between EUR0.00 and
EUR107.21 in 50% of patients, EUR129.17 and EUR387.51 in 43% of patients and
EUR516.68 and EUR775.02 in 7% of patients. FM was administered orally by the
patient and did not require any in-clinic treatment, there was no treatment
linked productivity loss. [2]

For the post hoc analysis 'Health care resource use associated with ferric
maltol and IV iron treatment for iron deficiency anaemia in patients with
inflammatory bowel disease', pHCRU was assessed based on the total costs of iron
therapy (including drug costs and administration), and the number of clinic
visits during the initial 12-week study period. Costs of IV FCM and FM were
applied to a German setting. Mean (standard deviation; SD) total treatment costs
per patient in the FM and IV FCM arms were EUR302.27 (EUR80.68) and EUR489.37
(EUR147.19) respectively. 87% of FM patients were still receiving treatment at
week 12, and 45% and 36% of IV FCM patients required a repeat course of IV iron
at weeks 4 and 12 respectively. The mean (SD) number of hospital/outpatient
visits during the study period for patients receiving IV FCM was 2.30 (0.88) and
the total dose of IV FCM received was 1621 mg (491 mg). The study showed that
the total per patient drug costs were approximately 1.6 times higher for
treatment with IV FCM than FM. The total cost of IV FCM is not only influenced
by the higher drug cost, but additional costs associated with IV administration
which was required to be carried out in an outpatient setting. FM had no
additional costs or resource use associated with administration and was
therefore less of a burden on local health care systems. FM was associated with
and substantially lower HCRU than IV FCM, and may provide a cost-effective oral
alternative to IV iron in patients with IBD. [1]

About oral ferric maltol (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.[6] For further information, please refer to the
product Summary of Product Characteristics, available at: https://www.ema.europa
.eu/en/documents/product-information/feraccru-epar-product-information_en.pdf

About Norgine

Norgine is a leading European specialist pharmaceutical company that has been
bringing transformative medicines to patients for over a century. Our commitment
to transforming people's lives drives everything we do and our European
experience, fully integrated infrastructure and exceptional partnership approach
enables us to quickly apply creative solutions to bring life-changing medicines
to patients that they may not otherwise be able to access. Norgine is proud to
have helped 22 million patients around the world in 2019 and generated EUR419
million in net product sales, a growth of 6% over 2018.

Norgine has a direct presence in 12 European countries, as well as Australia and
New Zealand. We also have a strong global network of partnerships in non-Norgine
markets. We are a flexible and fully integrated pharmaceutical business, with
manufacturing (Hengoed, Wales and Dreux, France), third party supply networks
and significant product development capabilities, in addition to our sales and
marketing infrastructure. This enables us to acquire, develop and commercialise
specialist and innovative products that make a real difference to the lives of
patients around the world.

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

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References

1. Howaldt S, et al. P685, presented at ECCO 2020
2. Howaldt S, et al. P331, presented at ECCO 2020
3. Howaldt S, et al. P567, presented at ECCO 2020
4. Howaldt S, et al. Presented at UEGW 2019, abstract number OP195
5. Lugg et al. 2014 Journal of Crohn's and Colitis 8, 876-880
6. FERACCRU® UK Summary of Product Characteristics, Norgine B.V.
January 2020. Available at https://www.ema.europa.eu/en/documents/
product-information/feraccru-epar-product-information_en.pdf
Accessed February 2020

GL/COR/0220/0231, Date of preparation February 2020

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