Ferric bepectate is expected to fill a significant gap in the market for patients requiring high dose IV iron treatments
About ferric bepectate
Ferric bepectate is a patented total-dosage iron therapy with a unique formulation and a promising pharmacokinetic profile. Unlike some currently available IV iron formulations, our product is based on modified starch rather than dextran. Once approved and launched, ferric bepectate is expected to fill a significant gap in the market for IV iron treatments capable of providing the high dose therapy without compromising patient safety.
We have encapsulated iron nanoparticles in such a way that they form a larger and stronger complex than other IV iron products. This means ferric bepectate can deliver high doses of intravenous iron in one setting, while ensuring that it is rapidly cleared from the plasma, thus minimizing the patient’s exposure to free iron.
The API is developed and produced by Serumwerk Bernburg.
The final pharmaceutical product will be produced in a cooperation with several contract manufactures.
Innovation
Iron4u have addressed the shortcomings of the traditional IV iron compounds by developing a new innovative high-dose IV iron product. We believe ferric bepectate has the potential to set a new benchmark in the field of intravenous iron therapy. Developed in partnership with the German company Serumwerk Bernburg, the product is now in Phase III clinical trials for human use as an injection or infusion.
Research
Our IV iron product ferric bepectate has successfully passed the preclinical phase and clinical phase I and II. The data from the clinical phase II was recently published here: Pharmacokinetics of ferric bepectate – a new intravenous iron drug for treating iron deficiency4
The phase III studies were initiated Q1 2019.
Research & Development is conducted in a cooperation between iron4u and Serumwerk Bernburg, partners, collaborators, consultants and external laboratories and clinicians.
4. Muñoz M et al., Basic Clin Pharmacol Toxicol. 2019;1–9. DOI: 10.1111/bcpt.13219
Ferric bepectate clinical studies
Process timeline
Future plans aim at documenting our product in all major sub-populations and conditions, where injectable iron is necessary or clinical convenient in order to restore adequate iron-levels.
Future plans include establishing a network of strong sales and marketing pharmaceutical companies that are capable of exploring the huge potential of our ferric bepectate product.
We will assess the most cost-effective strategies for the world-wide marketing and be open for:
- Partnerships with pharmaceutical companies
- Licensing agreements
- Establishment of own subsidiaries
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