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 in 2019. 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 ferric bepectate is available across a broad spectrum of unmet needs. That includes the 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 ferric bepectate in patients aged 6 months to 18 years. We recently published the results of our Phase II clinical trials in adults, which confirmed ferric bepectate’s highly attractive product profile.