A New Benchmark For IV Iron
Iron4u, have addressed the shortcomings of the current IV iron compounds by developing a new innovative high-dose IV iron product. We believe Polyglucoferron could 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.
Once approved and launched, Polyglucoferron is expected to fill a significant gap in the market for IV iron treatments capable of providing the high doses demanded by current deficiency levels worldwide, yet without compromising patient safety. Polyglucoferron is a patented total-dosage iron therapy with a unique formulation and an ideal pharmacokinetic profile. Unlike some currently available IV iron formulations, our product is based on modified starch rather than dextran.
We have encapsulated iron nanoparticles in such a way that they form a larger and stronger complex than other IV iron products. This means Polyglucoferron can deliver high doses of intravenous iron while ensuring that they are cleared rapidly from the plasma, thus minimizing the patient’s exposure to potentially damaging free iron.
Our market analyses indicate that the commercial potential for a truly effective and well-tolerated IV iron treatment is enormous. “Intravenous iron sales in the US alone are set to reach $1 billion within a few years. In the longer term, the US market could be worth more than $5 billion. The high levels of unmet need for iron-deficiency therapy worldwide suggest a wealth of opportunities for rapid growth with the right product.”
We also want to make sure that Polyglucoferron is available across a broad spectrum of unmet needs. That includes the particular challenges of treating iron deficiency in children, which can have serious long-term consequences for growth, development and immunity to infection.
In this respect, we achieved an important milestone on 1 December 2017, when the European Medicines Agency (EMA) agreed to our pediatric investigation plan (PIP) to study Polyglucoferron in patients aged 6 months to 18 years. We expect shortly to publish the results of our Phase II clinical trials in adults, which confirmed Polyglucoferron’s highly attractive product profile. After many years of working on improved options for iron-deficient patients and their clinicians, Iron4u is well on the way to redefining the standard of care for IV iron therapy.