Iron4u
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We aim to develop and market a new generation patented human injectable iron product based on ferric bepectate

About iron4u

Founded in Denmark in 2012 by investors from 5 European countries, iron4u’s main focus is to develop and register a new generation patented human injectable iron product based on ferric bepectate and to market the product world-wide. We are cooperating with the German company Serumwerk Bernburg and discussions with licensing partners are ongoing.

The company focuses on improving the treatment of iron deficiency for humans. In addition, iron4u have marketed products aiming at optimizing treatment of iron deficiency in the veterinary setting.

Learn about our product journey

The vision

The vision of iron4u is to improve the care of iron deficiency and iron deficiency anemia through the development and introduction of new innovative iron therapy solutions – building on the vast amount of evidence and learnings from 50+ years of experience with oral and parenteral iron therapy.

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Our 5 guiding principles

1

The characteristics of the iron complex should minimize the risk of free iron in plasma

2

Iron complex size and binding strength should be designed to avoid urinary iron excretion

3

The iron complex design should promote fast removal of iron from plasma into the RES

4

Administration should be simple, securing convenience – and limiting dosing errors

5

Dextran related anaphylaxis should be avoided by using non-dextran-based carbohydrates

The mission

It is iron4u’s mission to introduce a new parenteral treatment solution for iron deficiency anemia that will solve some of the historical shortcomings of parenteral iron compounds, offering an attractive, well documented and cost-effective solution for combating iron deficiency anaemia in both rich and poor countries – we aim to change the future of IV iron.

In iron4u we have clear and passionate feelings about how global iron deficiency should be solved. We believe that no single initiative can stand alone but that it should be a coordinated effort covering below initiatives:

  • Public education
  • Nutritional supplementation
  • Early diagnosis of conditions and diseases affecting iron balance
  • By using oral iron, in the cases where the level of iron deficiency and expected medication adherence combined makes it a relevant clinical choice
  • By timely and efficient use of well documented parenteral iron therapy solutions in cases where oral iron is not the optimal solution

The story so far

  • 2007

    The IV iron therapy ferric bepectate is invented by the German company Serumwerk Bernburg, who will also be the producer of the API.

  • 2011

    Initial plan launched to enter market using an application based on bibliographic data, plus a preclinical package and a phase-III clinical study in a hemodialysis population.

  • 2012

    Foundation of iron4u with the specific purpose to develop and market ferric bepectate for iron deficiency.

    Ferric bepectate was patented and a decision was made to go for a hybrid application, demanding more preclinical studies as well as a phase-1 clinical study.

  • 2014

    Authorities concluded that they assumed the active ingredient to be the entire iron sugar complex, requiring more studies.

  • 2015

    Knowledge obtained from initial studies shows that ferric bepectate’s properties differentiate significantly from existing human injectable iron products.

  • 2016

    Based on the emerging strong product profile, decision was taken to go for full/mixed application in order to document the differences between ferric bepectate and other injectable iron products.

    Preclinical phase completed

  • 2017

    Clinical Phase I completed

  • 2018

    Clinical Phase II completed

  • 2019

    Initial discussions with licensing partners.

    Initiation of International Phase III program

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The team

The iron4u team consist of a group of people, most with 20 years + experience in management positions, primarily in pharma companies. Several team members have more than 20 years’ experience in the human and veterinarian injectable iron business. Iron4u currently employs two highly skilled and experienced veterinarians. Furthermore, the team also include two senior medical doctors; one specialized in clinical pharmacology, has initiated and led numerous scientific studies, and has served as Medical Director in Astra and Astra Zeneca for more than 20 years. The other is specialized in cardiology and internal medicine, has a doctorate in medicine, a master’s degree of public administration from CBS, and has several years of experience as assistant professor and as member of the Regional Ethical Committee.

Clinical development of ferric bepectate is conducted by the two doctors in cooperation with the German Fraunhofer Institut and the Danish integrated drug development consultancy, Klifo.

Preclinical work is conducted in a cooperation with the companies: Serumwerk-Bernburg, Granzer from Munich, Onco-design from Paris and Eurofins from Denmark.

Dr. Christoph Huschka

Managing Director

Dr. Christoph Huschka

Managing Director

Christian Bent Rode

Finance Manager, CFO

Christian Bent Rode

Finance Manager, CFO

Merete Vaage-Nilsen

Associate Medical Director

Merete Vaage-Nilsen

Associate Medical Director

Stig Waldorff

Medical Director

Stig Waldorff

Medical Director

Niels-Erik Manniche

Regulatory Affairs & GDP Manager

Niels-Erik Manniche

Regulatory Affairs & GDP Manager

Odd Vaage-Nilsen

Advisor and Member of the Board

Odd Vaage-Nilsen

Advisor and Member of the Board

Colin Boots

Senior Consultant

Colin Boots

Senior Consultant

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MORE

Our innovation addresses many of the shortcomings of traditional IV iron compounds

Iron deficiancy is the most widespread nutritional disorder in the world

Ferric bepectate expected to fill significant gap in market for high dose IV iron treatments

Building on more than 50 years of experience, we aim to improve the quality of life for iron deficiency and iron deficiency anemia patients

Join us

Dronninggaards Alle 136
2840 Holte
Denmark

+45 4547 5040

 

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