The IV iron therapy ferric bepectate is invented by the German company Serumwerk Bernburg, who will also be the producer of the API.
We aim to develop and market a new generation patented human injectable iron product based on ferric bepectate
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.
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
The characteristics of the iron complex should minimize the risk of free iron in plasma
Iron complex size and binding strength should be designed to avoid urinary iron excretion
The iron complex design should promote fast removal of iron from plasma into the RES
Administration should be simple, securing convenience – and limiting dosing errors
Dextran related anaphylaxis should be avoided by using non-dextran-based carbohydrates
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
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.
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.
Authorities concluded that they assumed the active ingredient to be the entire iron sugar complex, requiring more studies.
Knowledge obtained from initial studies shows that ferric bepectate’s properties differentiate significantly from existing human injectable iron products.
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
Clinical Phase I completed
Clinical Phase II completed
Initial discussions with licensing partners.
Initiation of International Phase III program
The iron4u team consist of an experienced network of people in different pharma companies. Several team members have more than 20 years’ experience in the human and veterinarian injectable iron business. The team includes medical doctors, specialized in clinical pharmacology, clinical trial management and regulatory affairs.
Clinical development of ferric bepectate is currently conducted in cooperation with the German Fraunhofer Institute. Preclinical work is conducted in a cooperation with the following companies: Serumwerk Bernburg AG, Granzer Regulatory Consulting & Services from Munich, Oncodesign from Paris and Eurofins from Denmark.