Helsinn Group and Pharmacosmos A/S, a family-owned Danish pharmaceutical company, have entered into an agreement for the exclusive US commercialization rights to Monofer, an innovative intravenous iron replacement therapy under development for the treatment of iron deficiency anemia.
Under the terms of agreement: Helsinn has obtained the exclusive rights to commercialize Monofer and any other iron isomaltoside 1000 products developed by Pharmacosmos in the US. Pharmacosmos is eligible for milestone payments of up to USD 130 million for Monofer in iron deficiency anemia in the US. In addition, Pharmacosmos will be eligible to receive further payments for the manufacture and supply of Monoferto Helsinn in the US.
Helsinn's chief executive officer, Riccardo Braglia, commented: "Helsinn is committed to improving the lives of patients by offering medicines which enable them to get the most out of every day, optimizing their quality of life and promoting their ability to remain on treatment regimens. Monofer provides a high dose iron replacement in a single administration, which may offer anemic patients a new, more convenient treatment option for rapidly restoring their iron stores and thereby, improve their symptom burden. We look forward to collaborating with Pharmacosmos and bringing Monofer to the US market."
Pharmacosmos' chief executive officer, Lars Christensen, commented: "This is a very important milestone for Pharmacosmos. The US market is the biggest market in the world. We believe that Monofer will serve yet unmet clinical needs with a clear potential to improve outcomes and convenience for patients suffering from iron deficiency anemia in the US. Helsinn's strong foothold in the hematology and oncology combined with Pharmacosmos' expertise on iron deficiency anemia will provide an excellent platform for the introduction of Monofer in the US. I expect that our alliance with Helsinn will bring further growth, significantly strengthening our ambition and possibilities to establish Monofer as the leading brand for iron deficiency anaemia management."
Monofer (10% iron isomaltoside 1000) is an iron-carbohydrate complex for intravenous administration. Monofer is already marketed in more than 30 countries, primarily in Europe, for the treatment of iron deficiency anemia. Monofer is under development in the rest of the world, including North America and Japan. It is believed that the structure of Monofer differentiates it from other intravenous iron replacement therapies, allowing the possibility to administer high iron doses in one visit over a short period of time for the benefit and convenience of patients and healthcare professionals. Monofer is manufactured by Pharmacosmos, Denmark.
Iron deficiency anemia (IDA) is a debilitating condition which affects almost 2 billion people worldwide, including over 7 million people in US. IDA is often associated with many chronic diseases such as renal diseases (including chronic kidney disease), cancers (including chemotherapy induced anemia), gynecologic disorders (including abnormal uterine bleeding) and inflammatory bowel disease (IBD).
The US market is estimated to be worth more than USD 600 million in 2014 and is expected to exceed USD 1 billion early after 2020.
Helsinn is a family run, privately owned pharmaceutical group focused on building quality cancer care with a large portfolio of products.