January 26, 2010
Pharmacosmos today announced that it has obtained marketing
authorisations for Monofer® in Denmark, Iceland and the
Netherlands. As Pharmacosmos' first marketing authorisations for
Monofer®, the decisions pave the way for the first wave of Monofer®
launches in the second quarter of 2010.
Monofer® (iron isomaltoside 1000) is a new treatment for iron
deficiency anaemia developed by Pharmacosmos. The only IV iron
preparation that offers both the widest accepted dose range and no
test dose requirement1, Monofer® has the potential to
help millions of patients each year.
The marketing authorisations in Denmark, Iceland and the
Netherlands enable Pharmacosmos to prepare to launch the product in
the first wave of countries in 2010. The decisions follow a
positive outcome for the registration of Monofer® in a
decentralised procedure in 22 European countries on 26 November
2009 - and Pharmacosmos expects to obtain marketing authorisations
in the remaining countries during 2010.
Lars Christensen, M.D., President and CEO of Pharmacosmos,
comments: "We are delighted to have received the first
marketing authorisation for Monofer®, especially as the decision
fits with our anticipated timeline for launch. Iron deficiency
anaemia is a global health problem. Patients suffering from it need
fast iron repletion in one treatment. That's what Monofer® offers -
and we believe it will be a very important product in the treatment
field."
Pharmacosmos is currently collaborating with its international
partners to prepare launch activities - and will be ready for the
first wave of launches later in the year.
As part of its ongoing clinical programme, Pharmacosmos
initiated a new international gastroenterological study2
in the treatment of iron deficiency anaemia in patients with
inflammatory bowel disease (IBD) in October 2009. The ongoing
clinical programme aims to expand the clinical documentation of the
safety and efficacy of Monofer® as a treatment for iron deficiency
anaemia within nephrology, oncology and gastroenterology.
The efficacy and safety of Monofer® have already been documented
in clinical studies in patients with chronic kidney disease (CKD)
and congestive heart failure (CHF).
Further information
Learn more and sign-up for the latest updates about Monofer® at
Monofer.com or contact:
Lars Christensen, M.D.
President and CEO
T: +45 59 48 59 59
E: monofer@pharmacosmos.com
References
1) Core SPC, 2) ClinicalTrials.gov identifier
no. NCT01017614
© 2010 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 and patients
suffering from iron deficiency.
Pharmacosmos is a privately-owned
Danish company and operates in more than 50 countries across
Europe, the Americas and Asia. Its facilities are approved by the
Danish Medicines Agency and the US Food & Drug
Administration.