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EFFICACY & SAFETY

Hb INCREASES WERE NON-INFERIOR
WITH 1 DOSE OF MONOFERRIC VS UP
TO 5 DOSES OF IRON SUCROSE

FERWON-IDA

A randomized (2:1), open-label, non-inferiority, actively-controlled pivotal trial studying 1,512 adult patients with IDA and intolerance or lack of response to oral iron.1 Monoferric was intravenously administered as a single dose of 1000 mg. Iron sucrose was dosed at 200 mg per dose up to a maximum of 5 doses according to standard practice or physician choice. See full study design below.

Mean change in Hb levels from baseline (co-primary endpoint)1
0.5012.51.52Hb change from baseline (g/dL)124Week80.41.192.052.490.71.482.142.49Monoferric1000 mg (N=1009)Iron Sucrose 200 mg up to 5x in 2 weeks (N=503)
0.5012.51.52Hb change from baseline (g/dL)1235674Week80.41.192.052.490.71.482.14Monoferric 1000 mg (N=1009)2.49Iron Sucrose 200 mg up to 5x in 2 weeks (N=503)

FERWON-NEPHRO

Randomized (2:1), open-label, non-inferiority actively-controlled pivotal trial in 1,538 adult patients with IDA and chronic kidney disease (eGFR <60 mL/min).2 Monoferric was intravenously administered as a single dose of 1000 mg. Iron sucrose was dosed at 200 mg per dose up to a maximum of 5 doses according to standard practice or physician choice. See full study design below.

Mean change in Hb levels from baseline (co-primary endpoint)1
00.51Hb change from baseline (g/dL)124Week80.210.50.911.140.430.751.061.22Monoferric 1000 mg (N=1027)Iron Sucrose200 mg up to 5x in 2 weeks (N=511)
00.51Hb change from baseline (g/dL)1235674Week80.210.50.911.140.430.751.06Monoferric 1000 mg (N=1027)1.22Iron Sucrose 200 mg up to 5x in 2 weeks (N=511)
  • Non-inferior Hb increases of 1.22 g/dL and 1.14 g/dL were similarly observed with Monoferric and iron sucrose, respectively, in IDA patients with CKD2

FERWON-IDA

  • More patients achieved an Hb increase ≥2 g/dL at Week 1 (5.3% n=960 vs 2.5% n=477) and Week 2 (32.6% n=912 vs 20.8% n=452) with Monoferric compared to iron sucrose (secondary endpoint)1
  • No significant differences were observed at Weeks 4 (56.9% n=903 vs 55.6% n=450) and 8 (67.1% n=903 vs 68.1% n=454)1
More Patients Achieved Hb Increases ≥2 g/dL sooner with Monoferric vs Iron Sucrose1
060402080100Percentage of patientsWeek 4Week 2Week 1Week 8Monoferric 1000 mgIron Sucrose 200 mg up to 5x in 2 weeks2.55.3N=960N=47720.832.6N=912N=45255.656.9N=903N=45068.167.1N=903N=454
060402080100Percentage of patientsWeek 1Week 2Week 4Week 82.55.3Monoferric 1000 mgIron Sucrose 200 mg up to 5x in 2 weeksN=960N=47720.832.6N=912N=45255.656.9N=903N=45068.167.1N=903N=454

CLINICAL TRIAL ADVERSE REACTIONS

Adverse reactions were reported in 8.6% (172/2008) of patients treated with Monoferric.3

Adjudicated serious or severe hypersensitivity reactions were reported in 6/2008 (0.3%) patients in the Monoferric group.3

Adverse reactions (≥1%) in patients receiving Monoferric in FERWON-NEPHRO and FERWON-IDA (secondary endpoint)
IRON SUCROSE(N=1000)MONOFERRIC(N=2008)ADVERSEREACTIONNAUSEARASH1.2%(24/2008)1.1%(11/1000)1.0%(21/2008)0.1%(1/1000)
IRON SUCROSE(N=1000)MONOFERRIC(N=2008)ADVERSEREACTIONNAUSEARASH1.2%(24/2008)1.1%(11/1000)1.0%(21/2008)0.1%(1/1000)

Hypophosphatemia (serum phosphate <2.0 mg/dL) was reported in 3.5% of Monoferric-treated patients.

NO SIGNIFICANT DIFFERENCES IN SERIOUS OR SEVERE HYPERSENSITIVITY REACTIONS BETWEEN MONOFERRIC AND IRON SUCROSE

Monoferric is contraindicated in patients with prior serious hypersensitivity reactions to Monoferric or any of its components.3

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Monoferric.3 Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse.

Incidence of serious or severe hypersensitivity reactions between Monoferric and iron sucrose (co-primary endpoint)1,2
0.3%00.5%1.5%0.1%0.7%0.9%1.1%1.3%Hypersensitivity ReactionsFERWON-NEPHROFERWON-IDA0.0%0.4%0.3%0.3%Monoferric 1000 mgIron Sucrose 200 mg up to 5x in 2 weeksN=1019N=506N=989N=494
0.3%00.5%1.5%0.1%0.7%0.9%1.1%1.3%Hypersensitivity ReactionsFERWON-NEPHROFERWON-IDA0.0%0.4%0.3%0.3%Monoferric 1000 mgIron Sucrose 200 mg up to 5x in 2 weeksN=1019N=506N=989N=494

MONOFERRIC IMPROVED FACIT-FATIGUE SYMPTOM SCORES AT WEEK 8

At Week 8, FACIT-fatigue symptom scores surpassed severe fatigue levels (<30 FACIT-fatigue score) (secondary endpoint).1

  • In FERWON IDA, there were no statistically significant differences between iron isomaltoside and iron sucrose in increase in FACIT fatigue score from baseline to week 81
Mean change in FACIT-fatigue symptom score* from baseline (secondary endpoint)1
032241684048FACIT-fatigue scoreBaselineWeek 824.6339.9325.7239.98Monoferric 1000 mgIron Sucrose 200 mg up to 5x in 2 weeksN=1000N=496N=916N=460
032241684048FACIT-fatigue scoreBaselineWeek 8<30 = severe fatigue24.6339.9325.7239.98Monoferric 1000 mgIron Sucrose 200 mg up to 5x in 2 weeksN=1000N=496N=916N=460

*Score range from 0 to 52 with higher scores indicating less fatigue.

FERWON-IDA
Study Design

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FERWON-IDA

Monoferric vs Iron Sucrose Evaluated at 114 US Sites1

Randomized (2:1), open-label, non-inferiority actively-controlled pivotal trial in 1,512 patients with IDA and who had documented intolerance or lack of response to oral iron.1

1,512 ADULT IDA PATIENTS

Select Inclusion Criteria

  • ≥18 years of age
  • Hb ≤11 g/dL
  • TSAT <20%
  • s-ferritin <100 ng/mL

Select Baseline Demographics

  • The median age of patients
    was 44 years (range 18–91)
  • 89% were women
  • 9.25 g/dL mean Hb for
    Monoferric patients
  • 9.17 g/dL mean Hb for iron
    sucrose patients
Randomized 2:1
493 received iron sucrose
  • 200 mg per dose
  • Up to 5 doses
  • Iron sucrose was administered as 200 mg undiluted IV injections over approximately 2–5 minutes and repeated according to standard practice or physician choice up to a maximum of 5 times within the first 2 weeks starting at baseline. A cumulative dose of 1000 mg was recommended
989 received Monoferric
  • One 1000 mg dose
  • IV infusion over at least 20 minutes
8-week assessment period
Co-primary endpoints1
  • Number with adjudicated serious or
    severe hypersensitivity reactions
  • Change in Hb from baseline to Week 8
Select secondary endpoints1
  • Hb increase of ≥2 g/dL
  • Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale

FERWON-NEPHRO
Study Design

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FERWON-NEPHRO

Monoferric vs Iron Sucrose Evaluated at 143 US Sites2

Randomized (2:1), open-label, non-inferiority actively-controlled pivotal trial in 1,538 patients with IDA and Non-Hemodialysis Dependent Chronic Kidney Disease (NDD-CKD) (eGFR <60 mL/min).2

1,538 ADULT IDA PATIENTS
WITH NDD-CKD

Select Inclusion Criteria

  • ≥18 years of age
  • Hb ≤11 g/dL
  • s-ferritin ≤100 ng/mL (or ≤300
    ng/mL if TSAT ≤30%)
  • Chronic renal impairment with
    eGFR between 15–59 mL/min
  • Either no ESAs or ESAs at a
    stable dose (+/–20%) for 4
    weeks before randomization

Select Baseline Characteristics

  • The median age of patients
    was 69 years (range 25–97)
  • 63% were women
  • 9.66 g/dL mean Hb for
    Monoferric patients
  • 9.71 g/dL mean Hb for iron
    sucrose patients
Randomized 2:1
511 received iron sucrose
  • 200 mg per dose
  • Up to 5 doses
  • Iron sucrose was administered as 200 mg undiluted IV injections over approximately 2–5 minutes and repeated according to standard practice or physician choice up to a maximum of 5 times within the first 2 weeks starting at baseline. A cumulative dose of 1000 mg was recommended
1,027 received Monoferric
  • One 1000 mg dose
  • Infusion over at least 20 minutes
8-week assessment period
Co-primary endpoints2
  • Number with adjudicated serious or
    severe hypersensitivity reactions
  • Change in Hb from baseline to Week 8

IN THE PHOSPHARE STUDY, THERE WAS SIGNIFICANTLY LOWER INCIDENCE OF HYPOPHOSPHATEMIA (<2 mg/dL) WITH MONOFERRIC VS FERRIC CARBOXYMALTOSE

  • Two identical, randomized (1:1), open-label, comparative trials in 245 patients total across two trials with IDA and intolerance or unresponsiveness to oral iron.6
  • Monoferric demonstrated significantly fewer incidences of hypophosphatemia than ferric carboxymaltose at any time from baseline to day 35 (primary endpoint).4
  • Hypophosphatemia (serum phosphate <2.0 mg/dL) was reported in 3.5% of Monoferric-treated patients in FERWON-NEPHRO and FERWON-IDA

TRIAL A

TRIAL B

Incidence of hypophosphatemia (serum phosphate level <2.0 mg/dL) in PHOSPHARE (Trial A)4
200401006080Patients with Hypophosphatemia, %AnyPostbaselineDay 0Day 1Day 7Day 8Day 14Day 21Day 35Infusion:Ferric carboxymaltose, 750 mgInfusion:Ferric carboxymaltose, 750 mgMonoferric, 100 0 mgMonoferric 1000 mg doseFerric carboxymaltose 1500 mg total dose1/560/5924/582/601/5924/581/5428/561/5838/563/5724/575/6345/600/630/60
Patients, No./Total No.Ferric carboxymaltoseMonoferric200401006080Patients with Hypophosphatemia, %AnyPost baselineDay 0Day 1Day 7Day 8TimeDay 14Day 21Day 3524/581/5928/561/5438/561/5824/573/5724/582/601/560/590/600/6345/605/63Infusion:Ferric carboxymaltose, 750 mgInfusion:Ferric carboxymaltose, 750 mgMonoferric, 1000 mgMonoferric 1000 mg doseFerric carboxymaltose 1500 mg total dose
Incidence of hypophosphatemia (serum phosphate level <2.0 mg/dL) in PHOSPHARE (Trial B)4
200401006080Patients with Hypophosphatemia, %AnyPostbaselineDay 0Day 1Day 7Day 8Day 14Day 21Day 35Infusion:Ferric carboxymaltose, 750 mgInfusion:Ferric carboxymaltose, 750 mgMonoferric, 100 0 mgMonoferric 1000 mg doseFerric carboxymaltose 1500 mg total dose0/530/6114/552/600/5825/561/5628/553/5833/533/5923/535/6242/570/620/57
Patients, No./Total No.Ferric carboxymaltoseMonoferric200401006080Patients with Hypophosphatemia, %AnyPost baselineDay 0Day 1Day 7Day 8TimeDay 14Day 21Day 3525/560/5828/551/5633/533/5823/533/5914/552/600/530/610/570/6242/575/62Infusion:Ferric carboxymaltose, 750 mgInfusion:Ferric carboxymaltose, 750 mgMonoferric, 1000 mgMonoferric 1000 mg doseFerric carboxymaltose 1500 mg total dose

Study limitations

The 2 trials enrolled mostly women with iron-deficiency anemia due to gynecological bleeding, who tend to have higher rates of hypophosphatemia. This likely explains the higher than anticipated incidence of hypophosphatemia following ferric carboxymaltose treatment. Trials did not measure clinical outcome.

PHOSPHARE
Study Design

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PHOSPHARE

Monoferric vs Ferric Carboxymaltose Evaluated at 30 US Sites4

Two identical, randomized, open-label, clinical trials in 245 patients with IDA and intolerance or unresponsiveness to oral iron.4

245 ADULT IDA PATIENTS

Trial A: 123 IDA Patients
Trial B: 121 IDA Patients

Select Inclusion Criteria:

  • ≥18 years of age
  • Hb ≤11 g/dL
  • s-ferritin <100 ng/mL
  • A history of intolerance or unresponsiveness
    to 1 month or more of oral iron

Select Exclusion Criteria:

  • Patients with reduced kidney function

Select Baseline

  • Trial A: mean age, 45.1 years; 95.9% women
  • Trial B: mean age, 42.6 years; 94.1% women

Randomized 1:1

117 received ferric carboxymaltose

Trial A: 61
Trial B: 61

  • 750 mg per dose on Day 0 and Day 7
  • 2 doses (1500 mg total)

123 received Monoferric

Trial A: 62
Trial B: 61

  • One 1000 mg dose at Day 0
  • Infusion over at least 20 minutes
35-day assessment period
Primary endpoint4
  • Incidence of hypophosphatemia (serum phosphate level <2.0 mg/dL) at day 35

These articles are provided by Pharmacosmos for discussion of FDA approved uses. Monoferric (ferric derisomaltose) should be used only according to the accompanying complete prescribing information.

SEE THE FULL
FERWON-IDA STUDY

See Monoferric Full Prescribing Information

SEE THE FULL
FERWON-NEPHRO STUDY

See Monoferric Full Prescribing Information

Artist rendition

HOW MONOFERRIC WORKS

Monoferric has an innovative matrix structure that enables high iron concentrations for a slow and controlled release.

LEARN ABOUT IRON MATRIX STRUCTURE

MORE THAN 10 YEARS OF INTERNATIONAL EXPERIENCE IN THE HIGH DOSE IV IRON MARKETPLACE

Monoferric was introduced 10 years ago as Monofer® in the EU.5 Over 16 million doses have been administered ex-US since launch, and it is available in more than 30 countries.5


SEE THE INTERNATIONAL PRESENCE OF MONOFERRIC

INDICATIONS

Monoferric is indicated for the treatment of iron deficiency anemia (IDA) in adult patients:

  • who have intolerance to oral iron or have had unsatisfactory response to oral iron
  • who have non-hemodialysis dependent chronic kidney disease (NDD-CKD)
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS

Monoferric is contraindicated in patients with a history of serious hypersensitivity to Monoferric or any of its components. Reactions have included shock, clinically significant hypotension, loss of consciousness, and/or collapse.


WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Monoferric. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Monoferric administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Monoferric when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Monoferric is contraindicated in patients with prior serious hypersensitivity reactions to Monoferric or any of its components. In clinical trials in patients with IDA and CKD, serious or severe hypersensitivity were reported in 0.3% (6/2008) of the Monoferric treated subjects. These included 3 events of hypersensitivity in 3 patients; 2 events of infusion-related reactions in 2 patients and 1 event of asthma in one patient.

Iron Overload

Excessive therapy with parenteral iron can lead to excess iron storage and possibly iatrogenic hemosiderosis or hemochromatosis. Monitor the hematologic response (hemoglobin and hematocrit) and iron parameters (serum ferritin and transferrin saturation) during parenteral iron therapy. Do not administer Monoferric to patients with iron overload.


ADVERSE REACTIONS

Adverse reactions were reported in 8.6% (172/2008) of patients treated with Monoferric. Adverse reactions related to treatment and reported by ≥1% of the treated patients were nausea (1.2%) and rash (1%). Adjudicated serious or severe hypersensitivity reactions were reported in 6/2008 (0.3%) patients in the Monoferric group. Hypophosphatemia (serum phosphate <2.0 mg/dL) was reported in 3.5% of Monoferric-treated patients in Trials 1 & 2.

To report adverse events, please contact Pharmacosmos at 1-888-828-0655. You may also contact the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.

Please see Full Prescribing Information.

References: 1. Auerbach M, Henry D, Derman RJ, Achebe MM, Thomsen LL, Glaspy J. Am J Hematol. 2019;94(9):1007‐1014. 2. Bhandari S, Kalra PA, Berkowitz M, Belo D, Thomsen LL, Wolf M. Nephrol Dial Transplant. 2020 [epub]. doi:10.1093/ndt/gfaa011. 3. Monoferric (ferric derisomaltose) Prescribing Information; Pharmacosmos Therapeutics Inc., Morristown, NJ: 2020. 4. Wolf M, Rubin J, Achebe M, et al. JAMA. 2020;323(5):432‐443. 5. Data on File. 2020. Pharmacosmos Therapeutics, Inc.

IMPORTANT SAFETY INFORMATION + -

INDICATIONS

Monoferric is indicated for the treatment of iron deficiency anemia (IDA) in adult patients:

  • who have intolerance to oral iron or have had unsatisfactory response to oral iron
  • who have non-hemodialysis dependent chronic kidney disease (NDD-CKD)
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS

Monoferric is contraindicated in patients with a history of serious hypersensitivity to Monoferric or any of its components. Reactions have included shock, clinically significant hypotension, loss of consciousness, and/or collapse.


WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Monoferric. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Monoferric administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Monoferric when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Monoferric is contraindicated in patients with prior serious hypersensitivity reactions to Monoferric or any of its components. In clinical trials in patients with IDA and CKD, serious or severe hypersensitivity were reported in 0.3% (6/2008) of the Monoferric treated subjects. These included 3 events of hypersensitivity in 3 patients; 2 events of infusion-related reactions in 2 patients and 1 event of asthma in one patient.

Iron Overload

Excessive therapy with parenteral iron can lead to excess iron storage and possibly iatrogenic hemosiderosis or hemochromatosis. Monitor the hematologic response (hemoglobin and hematocrit) and iron parameters (serum ferritin and transferrin saturation) during parenteral iron therapy. Do not administer Monoferric to patients with iron overload.


ADVERSE REACTIONS

Adverse reactions were reported in 8.6% (172/2008) of patients treated with Monoferric. Adverse reactions related to treatment and reported by ≥1% of the treated patients were nausea (1.2%) and rash (1%). Adjudicated serious or severe hypersensitivity reactions were reported in 6/2008 (0.3%) patients in the Monoferric group. Hypophosphatemia (serum phosphate <2.0 mg/dL) was reported in 3.5% of Monoferric-treated patients in Trials 1 & 2.

To report adverse events, please contact Pharmacosmos at 1-888-828-0655. You may also contact the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.

Please see Full Prescribing Information.

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