Our History

Pharmacosmos’ history in brief

Pharmacosmos was established in 1965 by Henry Christensen MD, PhD, who was succeeded by his youngest son Lars Christensen, MD, as CEO in 1993. The company has since its establishment remained an independent family owned company.

The first 500 m2 manufacturing site – site Viby – was established in 1965 in a former dairy in a small village about 40 kilometres from the current site Holbaek. The original manufacturing site was expanded to approximately 1800 m2 in 1973.

Originally, the company was an API manufacturer of dextran powder of clinical grade, pharmacopoieal quality for production of infusion solutions and iron complexes. The API was and is still available in powder and/or bulk solutions for the manufacturing of veterinary iron dextran injection.

The company gained GMP approval from Danish Ministry of Health early-on, followed by a number of US FDA approvals after a 1983 US FDA inspection carried out by Mr Charles A. Wayne.

1983:  FDA approval of 10% iron dextran bulk solution for veterinary use;

1988:  FDA approval of 20% iron dextran bulk solution for veterinary use; and

1992:  FDA approval of 14-18% iron dextran powder for the manufacture of InFed® (5% iron dextran injection for humans marketed by Watson/Actavis).

Since 1983 Pharmacosmos has been the largest supplier to the US market of bulk iron dextran solutions for veterinary use.

From 1992 – 1996 InFed® was the only IV iron preparation approved in the US, and InFed still maintains a significant share of the US IV iron market.

In 1998 Pharmacosmos initiated the planning of a new manufacturing site – in Holbaek, which was inaugurated November 2003. The first US FDA inspection and approval took place in 2005.

The new site in Holbaek was originally 13,500 m² but was extended in 2009 with 1500 m² (500 m² office space and 1000 m² storage), and a further expansion of 500 m² synthesis plant (+ 400 m² pipe gallery) is currently in process to be completed in 2014.

In 2004 Amersham Bioscience (successor of Pharmacia) terminated manufacturing of pharmacopoieal dextrans, and Pharmacosmos has since been the major manufacturer of Dextran 1, 40 and 70 USP/EP. In addition hereto, Pharmacosmos manufactures a broad range of dextran fractions with other molecular weights than stated in the pharmacopoeias, i.e. Dextran 500 and Dextran 10 both in technical as well as pharmaceutical quality.

Since the end of the 1990s Pharmacosmos has in addition to the manufacture and supply of bulk APIs expanded to also focus on developing a portfolio of branded finished products within both human and veterinary iron injectables.

All finished products are manufactured by contract manufacturers based on Pharmacosmos’ APIs.

Human iron injectable brands

Approvals

2001:  CosmoFer (Low molecular weight iron dextran) - EU approval

2009:  Monofer (10% iron isomaltoside 1000) - EU approval

2013:  Diafer (5% iron isomaltoside 1000) – EU approval

Monofer is currently approved in 28 countries, including 21 EU countries. CosmoFer is approved in more than 45 countries and Diafer is approved in 4 EU countries.

CosmoFer is based on the same API as applied to the manufacturing of InFed® in the US.

Monofer is an innovative iron compound for administration of IV iron in high doses by fast infusion.

Diafer is approved for use for patients on haemodialysis.

Pharmacosmos has own sales organisations for human iron products in Denmark, Sweden, Norway, UK and Ireland. Outside these countries, Pharmacosmos markets and sells through local partners.

Veterinary iron injectable brand

Approvals

2008:  Uniferon 20% - EU approval

2011:  Uniferon 10% - US FDA approval

2011:  Uniferon 20% - US FDA approval

Uniferon is marketed in more than 28 countries.

Pharmacosmos has subsidiary with own sales organisation for Uniferon in the US. Outside the US Pharmacosmos markets and sells through local partners.

Pharmacosmos today

• Specialised in iron therapy
• Develop, manufacture and market medicines for treatment of iron deficiency anaemia in humans and animals
• Specialised in carbohydrate APIs
• Manufacture and market Pharmaceutical Quality and Technical grade Dextrans 
• Pharmacosmos is a fully integrated pharmaceutical company with expertise in manufacturing, clinical research and development, regulatory, medical affairs and sales and marketing.
• Pharmacosmos is conducting a number of clinical studies with Monofer in a number of countries, including the US, guided and organised from Holbaek and assisted by local CRO companies.
• Pharmacosmos has 103 employees in Denmark and 25 employees in subsidiaries in the US, UK, Ireland, Sweden, Norway and Singapore.

Pharmacosmos – key events

1965:           Established by Mr Henry M. Christensen,
                   M.D., D.Sc.

1983:           FDA approval for 10% iron dextran bulk solution

1988:           FDA approval for 20% iron dextran bulk solution

1992:           FDA approval for supply of API for InFeD^® in the US

2000:           CosmoFer^® launch in collaboration with EU partners

2003:           Inauguration of new 13,000 m² cGMP manufacturing facility in Holbaek, Denmark

2004:           Overtaking of clinical grade dextrans supply from Amersham Biosciences

2008:           Registration of Uniferon^® in EU and Asia

2009:           Registration of Monofer^® in 22 EU countries

2009:           1500 m² expansion site Holbaek

2011:           FDA approval for 20% Uniferon® in the US

2011:           FDA approval for 10% Uniferon in the US

2013/14:      500 m² expansion of site Holbaek – synthesis of derivatives (DEAE and others)