Orion receives positive CHMP opinion for new intensive care sedative, dexdorÂ® (dexmedetomidine)
ORION CORPORATION STOCK EXCHANGE RELEASE 22 July 2011 at 10.55Â EEST
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
forÂ dexdorÂ® (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 forÂ dexdorÂ® in all European Union Member
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.
IfÂ dexdorÂ® 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 PrecedexÂ® 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
Timo Lappalainen Olli Huotari
President and CEO 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 EasyhalerÂ®
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.
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Source: Orion Oyj via Thomson Reuters ONE