November 1, 2018 Pharmacosmos presents positive results from pivotal phase III trial in the USA at the 60th annual meeting of the American Society of Hematology

Pharmacosmos A/S announces publication of the abstract presenting positive results from the FERWONIDA study.  FERWONIDA was a randomized, open-label, comparative, multi-center trial conducted in the USA. Patients were randomised to receive either Monofer® (iron isomaltoside 1000) administered as a single dose of 1000mg or Venofer® (iron sucrose) administered as 200mg slow IV bolus injections according to label and repeated up to 5 times to reach a cumulative dose of 1000mg. The co-primary endpoints of the trial were adjudicated serious or severe hypersensitivity reactions starting on or after the first dose of randomised treatment, and change in hemoglobin levels from baseline to week 8. Adjudication of hypersensitivity reactions was performed in a blinded fashion by an independent Clinical Endpoint Adjudication Committee.

Pharmacosmos is pleased to announce that both primary endpoints in FERWONIDA study were met. The frequency of subjects reporting adjudicated serious or severe hypersensitivity reactions was 0.3% in the iron isomaltoside group and 0.4% in the iron sucrose group, thus there was no difference between the two treatment arms. Iron isomaltoside lead to a significantly more rapid and increased hemoglobin response in the first 2 weeks. This was reflected in both hemoglobin change from baseline and proportion of responders with hemoglobin increases ≥2 g/dL. These results reinforce once again the good safety and efficacy profile of Monofer®. Moreover, a larger improvement in FACIT fatigue scores was observed with iron isomaltoside at week 1.  For both products serum phosphate levels remained largely within the normal range at all time-points, and no patients had s-phosphate <1mg/dL, indicating neither formulation induced profound hypophosphatemia. 

Lars Lykke Thomsen, Chief Medical Officer at Pharmacosmos, said: “These are very good results for Monofer® and I believe they will be important in the upcoming NDA application process for Monofer® in the USA. The simple dosing regimen used for Monofer® in this study could address an unmet need in the USA as no product to date has been licensed by the FDA for administration of 1000mg IV iron in a single dose.”

Michael Auerbach MD, lead author on the FERWON trial abstract, said: “Many patients with iron deficiency anaemia benefit most from 1000 mg of iron administered intravenously and these results show that iron isomaltoside can provide that benefit, safely and effectively in a single dose. I’m looking forward to having another intravenous iron formulation available in the US to allow a total dose infusion to be administered safely in a brief, single visit.”

For more information, please contact:
Chief Medical Officer, Lars Lykke Thomsen, MD
Tel: +45 59 48 59 35
Switchboard: +45 59 48 59 59                                                                       

For media/external inquiries, please contact:
Fonnesbech & Estrup
Adam Estrup
Tel: +45 28 74 87 10
adam@estrup.dk

Link to abstract: https://ash.confex.com/ash/2018/webprogram/Paper110199.html

About Monofer®


Monofer® (iron isomaltoside 1000 for injection) is an iron-carbohydrate complex for intravenous administration. Monofer® is marketed in more than 30 countries worldwide for the treatment of iron deficiency and iron deficiency anaemia. Monofer® is manufactured by Pharmacosmos A/S, Denmark.

About iron deficiency anaemia (IDA)


Iron deficiency anaemia (IDA) is a debilitating condition that affects almost 1 billion people worldwide. IDA is often associated with many chronic diseases such as renal diseases (including Chronic Kidney Disease), cancers (including chemotherapy induced anaemia), gynecologic disorders (including abnormal uterine bleeding) and inflammatory bowel disease, IBD.

About Pharmacosmos


Headquartered in Denmark, Pharmacosmos is a family-owned, international healthcare company with more than 50 years of innovation and leadership in iron- and carbohydrate-based treatments and solutions for human and animal use.

A research-based company, its ongoing R&D programme focuses on improving the lives of patients with iron deficiency with or without anaemia. More than 1 billion people live with iron deficiency anaemia and it is the leading cause of death for an estimated 180,000 people every year. This makes it one of the largest global health challenges of our time.

Pharmacosmos has subsidiaries in US, UK, Ireland, Germany, Sweden and Norway and its products are marketed in more than 80 countries around the world. Its manufacturing facilities are approved, among others, by the Danish Medicines Agency and the US FDA.

Pharmacosmos