Status on the development of Polyglucoferron
The injectable human iron product Polyglucoferron was invented by the German company Serumwerk Bernburg, who will also be the producer of the product.
The intention was originally to enter the market using bibliographic data in the registration process, based on iron as the active ingredient. A limited preclinical package was conducted, as well as a phase-3 clinical study in a hemodialysis population.
The feed-back from the authorities in 2 countries clearly demonstrated that they assumed the active ingredient to be the entire iron sugar complex – and more studies would be necessary in order to obtain approval.
A series of meetings led to the foundation of iron4u with the specific target to develop a file strong enough to obtain marketing approval. iron4u’s prime focus is thereafter to market Polyglucoferron world-wide.
Several important decisions were taken:
- Immediate steps were taken in order to patent Polyglucoferron.
- It was decided to go for a hybrid application, this demanded among others more preclinical studies as well as a phase-1 clinical study.
Most of the studies are conducted, the knowledge obtained from these studies, on top of the knowledge obtained from previously conducted studies, led us to understand that:
- Polyglucoferron’s properties differentiate from existing human injectable iron products, predicting a product of huge potential when large doses of iron needs to be administered in a timely acceptable manner.
- Based on this knowledge the decision was taken to go for full/mixed application in order to be able to document difference between Polyglucoferron and other injectable iron products.
This strategy demands even more preclinical data as well as more data from clinical phase-2 and additional data from pivotal clinical phase-3 studies.
We have been working hard the last few years to conduct these studies, so far it is looking very promising.
- In the autumn of 2016 we will have the data from the ongoing phase-2 clinical study.
- The necessary pivotal phase-3 studies will be intiated in Q4 of 2016.