Pharmacosmos to initiate large-scale clinical study programme in support of Monofer® US FDA approval

Holbæk, Denmark, 19 August 2016 – Pharmacosmos announces initiation of a novel study programme to obtain FDA approval of Monofer® while continuing its search for a partner to commercialise Monofer® in the US.

The study programme consists of two large-scale US trials in patients with iron deficiency anaemia (IDA) and non-dialysis dependent chronic kidney disease (NDD-CKD).

The trials will enrol 3,000 patients from more than 300 sites across the US, randomised into groups receiving either Monofer® (iron isomaltoside) or Venofer® (iron sucrose), the most widely used IV iron preparation in the world.

Pharmacosmos expects the trials to complement its recently completed studies in iron deficiency anaemia and chronic kidney failure, ‘Provide’ and ‘Progress’, which respectively demonstrated superiority on their primary efficacy endpoints over iron sucrose and oral iron.

“Our US studies will be pivotal in our efforts to document Monofer® as the IV iron that can improve patient outcomes by correcting iron deficiency anaemia in one visit with a good safety profile. It will add to the already substantial documentation of Monofer®, including testing of more than 1,700 patients in controlled, prospective trials and in-market experience from more than the 4 million doses administered,” said Lars Lykke Thomsen, MD, VP and Chief Medical Officer at Pharmacosmos.

The studies will further supplement Pharmacosmos’ landmark study (IRONMAN) recently initiated in collaboration with the British Heart Foundation in patients with chronic heart failure to demonstrate improvements in hard clinical endpoints such as cardiovascular mortality and hospitalisation for worsening heart failure with Monofer®.

Both US studies will be funded by Pharmacosmos and are expected to run over several years.

“We have a strong belief in the benefits Monofer® provides to patients and are therefore ready to make the investments needed to make Monofer® available to US patients. The studies will provide a strong platform for our launch of Monofer® in the US together with a future partner and will support Monofer® outside the US as well,” said Lars Christensen, MD, CEO, Pharmacosmos.