Ferinject®

Iron Deficiency Anemia-IDAy

• IDA is the most common and widespread pnutritional disorder in the world.

• It is the only nutrient deficiency also prevelant inIt is the only nutrient deficiency also prevelant in industrial countries.

• Some disorders such as IBD are prone to• Some disorders, such as IBD, are prone to develop IDA.1/3 f th IBD’ ti t h d d Hb• 1/3 of the IBD’s patients has reduced Hb.

• Every second patient is ID.

• Kulnigg S et al. Am J Gastroenterol 2007;102:1

Factors to IDA in IBD’s patientsp

Ulcerated intestinal mucosa

IDA Chronic blood loos

Absorption impairment

Elevated hepcidinhepcidin

IDA-Symptomsy p

Fatigue

DizzinessReduced cognitive function

IDA symptoms

Hospitalization(sever cases)

ADL impairment (sever cases)impairment

Fatigue, weakness and impaired physical function adversely affect the lives and well being of your patients (Cancer)the lives and well-being of your patients (Cancer)

Fatigue has a greater impact on the life of a cancer patient than pain1

► In cancer patients, fatigue i ifi tl i t Q L2 3

80

70

Oncologist (n = 197)Patient (n = 419)

significantly impacts QoL2,3

► 61% of cancer patients

70

60

50

40

61%

37%

61%

nse

(%)

psurveyed (n=419) said that fatigue had a more substantial

40

30

20

10

19%Res

pon

effect on their daily lives than pain1

Responses to the question:

0Fatigue Pain

(Patient) Which symptom do you think affects/affected your everyday life more, pain or fatigue?

(Oncologist) Which symptom do you think affects your patients’ everyday life more pain or fatigue?

1. Vogelzang NJ et al. Semin Hemat1997;34:4,

2. Cella D et al. Semin Oncol 1998;25:43,3. Cella D. Cancer 2008;113(6):1480–8.

everyday life more, pain or fatigue?

Oral treatment100–200 mg

Oral treatment

Up to 90% of oral iron is not absorbed Oesophagus

iron

10% absorbed

LiverGallbladder

StomachStomachDuodenum

Colon

Rectum

2008AG, VerlagMED -UNIAnemia in inflammatory bowel diseases. C. Gasche

Oral iron treatment

• Easy to administer & Low cost• Easy to administer & Low cost.• Poor absorption from the gastrointestinal tract.• Gastrointestinal side effects

constipation 35%nausea 10%vomiting 8%diarrhea 6%

Variable compliance• Variable compliance.• Interaction with medications.• Interaction with food.Interaction with food.• Can’t balanced continuance iron loose.

Charytan C et al. Nephron Clin Pract 2005; 100: c55-c62

The majority of patients require at least 1 g of utilizable iron

► Post-Partum:

utilizable iron

– Van Wyck DB et al. Obstet Gynecol 2007;110:267: 1,403 mg iron

– Breymann C et al. Int J Gynaecol Obstet 2008;101:67: 1,347 mg iron

– Seid MH et al. Am J Obstet Gynecol 2008;199:435: 1,504 mg iron

► Heavy Menstrual Bleeding:– Van Wyck DB et al. Transfusion 2009;49:2719: 1,568 mg iron

► Oncology: gy– Tschechne B et al. DHGO Congress poster, Berlin 2010 1,333 mg iron

– I.V. iron other studies: 750–1,200 mg iron

► CKD:– Qunibi WY et al. Nephrol Dial Transplant 2010 (Epub ahead of print): 1,218 mg iron

► IBD:– Kulnigg S et al. Am J Gastroenterol 2007;102:1: 1,399 mg ironKulnigg S et al. Am J Gastroenterol 2007;102:1: 1,399 mg iron

IV Iron Therapy – What are we l ki f ?looking for?• Safety & effectiveness• Safety & effectiveness• Rapid correction of iron deficiency• Low toxicity• Low reactivity with molecules in blood and living

cells• No induction of oxidative stress• Minimum repeated infusion

Ferinject® – Breakthrough next generation I V irongeneration I.V. iron

FERINJECT

• Ferinject® is a stable complex free of dextran• Ferinject is a stable complex free of dextranDesigned to overcome current I.V. iron limitationslimitations

• Ferric carboxymaltose - FCML i i i l d• Low immunogenic potential and iron-induced toxicity

• Well documented safety and tolerability profile• Single dose up to 1000 mg iron in 15 minutesSingle dose up to 1000 mg iron in 15 minutes

only• No test dose required• No test dose required

FERINJECT

• Unique carbohydrate shell• Unique carbohydrate shell• Highly stable type I iron complex

f• Dextran-free• PH 5–7• Physiological osmolarity• Rapid and selective delivery from plasma toRapid and selective delivery from plasma to

RES of the liver,spleen and bone marrow.

Metabolism and toxicity of an ICCMetabolism and toxicity of an ICC

M hTransferrin

Macrophage

Iron(III)-hydroxide/oxide coreICC

Carbohydrate shell

Fe3+

Fe2+

Lysosome

e

Cyt b

Fe2+Ft

F ti

DMT1y

LIPFerroportin

Fe2+ Fe3+ TransferrinHepcidin

CeruloplasminDMT1: Divalent metal transporter 1; LIP: labile iron pool; Ft: ferritin.

Ferinject® provides a more rapid correction of iron deficiency compared with oral iron (IBD)deficiency compared with oral iron (IBD)

Ferinject® (n=136)100

80 p-values for difference:

Oral iron (n=60)

nder

s (%

)

60

p values for difference:

•Week 2: p=0.0051

•Week 4: p=0.0346

•Kaplan-Meier analysis

Res

pon

40

20

yof cumulative Hb

responder rate: treatment comparison,

log-rank test: 0.000920

0Week 4Week 2Baseline

VisitWeek 8 Week 12

Ferinject® provides a more rapid correction of iron deficiency compared with oral iron (HMB)deficiency compared with oral iron (HMB)

Significantly more patients with a Hb increase of ≥3g/dl

Significantly more patients achieving a Hb >12g/dl

Significantly higher serum ferritin values

100p<0.001

with a Hb increase of ≥3g/dl

100p<0.001

achieving a Hb >12g/dl

250p<0.001

serum ferritin values

80

60

tient

s

80

60

tient

s

200

150µg/d

l

40

20% o

f pat40

20% o

f pat 100

50

∆ Fe

rriti

n

00 Ferinject®(n=228)

Oral Iron(n=225)

0

∆

Ferinject®(n=228)

Oral Iron(n=225)

Ferinject®(n=228)

Oral Iron(n=225)

Ferinject® was significantly superior to oral iron in normalizing haemoglobin and replenishment of iron stores

2719492009T f it lDBW kV 2719:49;2009Transfusion . et alDB WyckVan

Only 1–2 injections of Ferinject®

needed in > 90% of patients1needed in > 90% of patients1

80

60

70

ient

s % 50

60

30

Pat

30

20

1 injection

0

10

Clinical Profile: Anaemia in postpartum

1 injection2 injection3 injections

1 van Wyck DB, 2007y

Ferinject® has a good and well documented safety and tolerability profiletolerability profile

Well tolerated even at single doses up to 1,000 mg iron

vent

s

Well tolerated even at single doses up to 1,000 mg iron

12

10Ferinject® (n=1968) Oral iron (n=834)

vers

e dr

ug e

v 10

8

ents

with

adv 6

4

% p

atie

Headache Nausea Decreased Rash Increased Dizziness Local AbdominalConstipation Abdominal Diarrhoea Faeces Vomiting

2

0Headache Nausea Decreased

serum phosphorus

Rash Increasedalanine

aminotransferase

Dizziness Local injection

site reaction

Abdominal pain

Constipation Abdominal pain

upper

Diarrhoea Faeces discoloured

Vomiting

Qunibi W. ERA-EDTA Congress poster 2008, SwedenL seng Williamson KA & Keating GM Dr gs 2009 69(6) 739

Ferinject® cumulative doses ≥1,000 mg iron in 88% of patients (n =1,736)

Lyseng-Williamson KA & Keating GM. Drugs. 2009;69(6):739

Ferinject® offers a simple and cost-effective treatment option for both physicians and patientsoption for both physicians and patients

► The associated savings with Ferinject® are that significant that it becomes the most economically viable option in three different therapeutic areas. These economic benefits are substantiated through the most optimal cost-neutral price and through the lowest administration costs in treating patients with iron deficiency

► Costs of administration – Ferinject® corresponding to 1,000mg iron is the lowest

400

300

389 374

250

370

23327020

Drug costs

Administration costs

200

100

€320 250

124

233

137

250

* Calculation of the administration costs for the individual products is based on the Swiss structure of rates

069

124 137for medical services (Tarmed)

Iron gluconate16x 62.5 mg iron

over 10*

Iron dextran1x 1,000 mg iron

over 7h

Iron sucrose2x 500 mg iron

over 3.5h

Ferinject®1x 1000 mg iron

in 15*

Szucs TD et al. Health-economic impact University of Zurich, Switzerland.

Ferinject® – Minimal intervention,maximum impactmaximum impact

High dose drip infusions

single dose up to 1000 mg ironin 15 minutes onlyin 15 minutes onlyno test dose required

500 mg (10 ml)concentration 50 mg iron/ml

Thank youThank you