Orion Corporation has received information that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the granting of marketing authorisation for dexdor® (dexmedetomidine), a new intensive care sedative.
The European Commission is expected to make the final decision on marketing authorisation in the coming months. If approved by the European Commission Orion would receive marketing authorisation for dexdor® in all European Union Member States.
Orion submitted a marketing authorisation application for dexmedetomidine for the evaluation by the European Medicines Agency in October 2010.
Dexmedetomidine is a sedative agent originated by Orion's pharmaceutical R&D. It is a relatively selective alpha2-agonist which acts on the central nervous system to produce sedation.
If dexdor® is granted marketing authorisation in Europe the product will be indicated for sedation of adult ICU (Intensive Care Unit) patients requiring a sedation level not deeper than arousal in response to verbal stimulation (corresponding to Richmond Agitation-Sedation Scale [RASS] 0 to -3).
Dexmedetomidine is available with the brand name Precedex® in more than 30 countries outside Europe, including the USA (since 2000) and Japan (since 2004). The distributor for the product outside Europe is Hospira under Orion's license.
|Timo Lappalainen |
President and CEO
|Olli Huotari |
SVP, Corporate Functions
Reijo Salonen, Senior Vice President, Research and Development tel. +358 50 966 3647
Orionintie 1A, FI-02200 Espoo
Orion is an innovative European R&D-based pharmaceutical and diagnostic company with a special emphasis on developing medicinal treatments and diagnostic tests for global markets. Orion develops, manufactures and markets human and veterinary pharmaceuticals, active pharmaceutical ingredients and diagnostic tests. Orion's pharmaceutical R&D focuses on the following core therapy areas: central nervous system drugs, cancer and critical care drugs, and Easyhaler® pulmonary drugs.
The Group's net sales in 2010 amounted to EUR 850 million. The Company invested EUR 85 million in research and development. At the end of 2010, the Group had a total of approximately 3,100 employees, of whom 2,450 worked in Finland and 650 in other countries. Orion's A and B shares are listed on NASDAQ OMX Helsinki.