Helsinn Group and the Danish pharmaceutical company, Pharmacosmos A/S, have formed an agreement for exclusive US commercialization rights to Monofer, an intravenous iron-replacement therapy under development for the treatment of iron deficiency anemia.

Under the 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 $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 Monofer to Helsinn in the US.

Monofe (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. Monofe is under development in the rest of the world, including North America and Japan. It is believed that the structure of Monoferdifferentiates 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.

Helsinn is a family run, privately owned pharmaceutical group headquartered in Lugano, Switzerland. Helsinn also has operating subsidiaries in Ireland, the United States, and a representative office in China. Helsinn’s business model is focused on the licensing of pharmaceuticals, medical devices, and nutritional supplement products in the therapeutic area of cancer care. Helsinn Group in‐licenses early‐to‐late stage new chemical entities, completing their development by performing preclinical and clinical studies and associated manufacturing activities. Helsinn then prepares necessary regulatory filings in order to achieve marketing approvals worldwide. Helsinn’s products are out‐licensed to its global network of marketing and commercial partners that have been selected for their local market knowledge. Helsinn supports these partners by providing a full range of product and scientific management services, including commercial, regulatory, and medical marketing advice. In March 2013, Helsinn established a new commercial organization within its subsidiary, Helsinn Therapeutics (US Inc.) n order to conduct direct sales and marketing activities within the US market.

Pharmacosmos A/S is a family-owned Danish pharmaceutical company with headquarters in Holbæk, Denmark. It was founded in 1965 and today sells its products in the UK and Scandinavia through its own subsidiaries and across the world through partners. It has a specific product focus in the development and marketing of medicines for the treatment of iron deficiency anemia and has a carbohydrate production platform with facilities in Denmark.

Source: Helsinn