December 19, 2016 Nippon Shinyaku enters into a license agreement with Pharmacosmos on an intravenous iron therapy, Monofer® (iron isomaltoside 1000)

Nippon Shinyaku enters into a license agreement with Pharmacosmos on an intravenous iron therapy, Monofer® (iron isomaltoside 1000)

Nippon Shinyaku Co., Ltd (HQ: Kyoto, President: Shigenobu Maekawa) and Pharmacosmos A/S (HQ: Holbaek, Denmark, President & CEO: Lars Christensen) announced that the two companies have signed a license agreement on Monofer® solution for intravenous injection/infusion, a treatment for iron deficiency. This agreement enables Nippon Shinyaku to exclusively develop and commercialize Monofer® in Japan.

Monofer® is an innovative iron-carbohydrate complex for high-dose intravenous administration developed and synthesized by Pharmacosmos A/S. Monofer® is commercialized by Pharmacosmos and its partner companies in more than 34 countries, primarily in Europe, for the treatment of iron deficiency with or without anaemia.

Patients with iron deficiency frequently suffer from symptoms like fatigue, headache, and shortness of breath or abnormal heartbeat caused by vital processes being compromised by the iron deficiency, such as impaired energy generation in cells. It is associated with various conditions such as certain gynaecological diseases (heavy uterine bleedings and post-partum haemorrhages) as well as gastrointestinal bleedings, chronic kidney disease and other relevant diseases.

Monofer® contains iron (III) tightly bound to a carbohydrate isomaltoside with a good safety profile. This enables delivery of full iron correction in fewer visits compared to current standard with existing intravenous iron preparations available in Japan.

Monofer® is expected to fulfil an unmet medical need in the treatment of iron deficiency associated with various conditions including gynaecological diseases. Nippon Shinyaku aims to contribute to improving treatment for patients with iron deficiency by launching Monofer® in Japan as soon as possible.

Monofer® is marketed in 34 countries via Pharmacosmos sales subsidiaries and exclusive partnerships. It is in development for all additional major markets, including the United States, France, Italy and Switzerland, which are available for partnering.

ABOUT NIPPON SHINYAKU CO., LTD.


Nippon Shinyaku, established in 1919, has a long-history as a research-oriented pharmaceutical company in Japan. It has been dedicated to research and development of innovative drugs.

Areas of specialty for both R&D and marketing by Nippon Shinyaku include urology, hematology, intractable and rare diseases, gynaecology and otorhinolaryngology. By implementing its own drug discovery research, licensing-in from other companies and product lifecycle management (PLCM), Nippon Shinyaku is striving to address unmet medical needs and speedily launch pharmaceuticals to help patients.

For further information, please refer to the company web-site: http://www.nippon-shinyaku.co.jp/english/

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 the Nordics, Germany, UK and US and its products are marketed in more than 80 countries across the world. Its manufacturing facilities are approved, among others, by the Danish Medicines Agency and the US FDA.

Pharmacosmos