Pharmacosmos receives positive outcome for registration of Monofer®

November 27, 2009

Monofer®, a new treatment for iron deficiency anaemia, received a positive outcome for its registration today. The decision paves the way for Monofer® to receive national marketing authorizations in 2010.

Monofer® (iron isomaltoside 1000) is the only IV iron preparation that offers both the widest accepted dose range and no test dose requirement1. It is indicated for the treatment of patients with iron deficiency anaemia, and can be administered to patients with various underlying conditions*.

Monofer® was granted a positive outcome today as part of a decentralized procedure in 22 European countries with Sweden as Reference Member State. Now, Pharmacosmos, the company that developed Monofer®, expects to obtain national marketing authorizations for Monofer® in 2010.

Lars Christensen, M.D., President and CEO of Pharmacosmos, comments: "We are very happy to have received the positive outcome. It marks another positive step forward in Pharmacosmos' endeavours to continuously improve treatments for patients with iron deficiency anaemia. There is increasing awareness among healthcare professionals that patients suffering from iron deficiency anaemia need increased iron dosing. By offering convenient infusion of large doses of iron, Monofer® will benefit many more patients than previously possible."

Anaemia is a global public health problem that has major consequences for social and economic development2. It is thought that 50 percent of anaemia cases are due to iron deficiency3 - and in 2002, iron deficiency anaemia was named as one of the major contributing factors to the global burden of disease2.

Clinical studies within nephrology, gastroenterology, obstetrics and gynaecology have indicated that 88-97 percent of the patients with iron deficiency anaemia require 1,000 mg of iron or more to be iron replete4,5,6.

The efficacy and safety of Monofer® has already been documented in clinical studies in patients with chronic kidney disease (CKD) and congestive heart failure (CHF)7,8. Pharmacosmos' ongoing clinical program includes additional Monofer® studies within nephrology, oncology and gastroenterology.

Learn more about Monofer® at Monofer.com.


Contact for further information

Lars Christensen, M.D.
President and CEO
T: +45 59 48 59 59
E: monofer@pharmacosmos.com


References

1) Core SPC, 2) World Health Organization. The World Health Report 2002: Reducing risks, promoting healthy life. Geneva, World Health Organization, 2002. 3) Iron Deficiency Anaemia: assessment, prevention, and control. A guide for programme managers. Geneva, World Health Organization, 2001 (WHO/NHD/01.3). 4) Quinibi W. et al. XLV ERA-EDTA Congress, May 10-13 2008, Stockholm, Sweden. 5) Quinibi W. et al. J Am Soc Nephrol 2007; 18: SU-PO 1029. P 813A. 6) David B. Van Wyck et al. Large-dose intravenous ferric carboxymaltose injection for iron deficiency anemia in heavy uterine bleeding: a randomized, controlled trial. Transfusion 2009 advanced access. 7) Poster No. M560, World Congress of Nephrology, May 22-26 2009, Milan, Italy. 8) Heart Failure Congress 2009, 30 May 2009 - 02 jun 2009, Nice, France.

* When oral iron preparations are ineffective or cannot be used. Where there is a clinical need to deliver iron rapidly. The diagnosis of iron deficiency anemia should be based on appropriate laboratory tests (e.g. serum ferritin, serum iron, transferrin saturation or hypochromic red cells).

© 2009 Pharmacosmos A/S. Monofer® is a registered trademark of Pharmacosmos A/S.

About Pharmacosmos A/S

Pharmacosmos develops and markets medicines for the treatment of iron deficiency. A research-based company, its ongoing R&D programme focuses on improving the treatment options for healthcare professionals, patients suffering from iron deficiency and veterinary treatments. .

Pharmacosmos is a family-owned Danish company and operates in more than 50 countries across Europe, the Americas and Asia. Its facilities are approved by both the Danish Medicines Agency and the US Food & Drug Administration.