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Orion Oyj: Orion receives first marketing authorisations for Bufomix Easyhaler® product


Orion receives first marketing authorisations for Bufomix Easyhaler® product

Orion Corporation has received Irish and Hungarian marketing authorisation for
Bufomix Easyhaler®, an inhaled budesonide-formoterol combination product
indicated for asthma and chronic obstructive pulmonary disease (COPD). In
this formulation, budesonide acts as an anti-inflammatory agent
and formoterol acts as a long-acting bronchodilator. The marketing
authorisation covers two strengths (budesonide 160 µg / formoterol 4.5 µg and
budesonide 320 µg / formoterol 9 µg) for the treatment of asthma and COPD in
patients above 12 years.

The Irish and Hungarian marketing authorisations are the first approvals of
the EU decentralized procedures (DCP) for 22 EU countries, in which Sweden
acted as a reference member state. National approval procedure of the
marketing authorisation application is ongoing in following EU countries:
Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, Greece,
Italy, Latvia, Lithuania, Luxembourg, Malta, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain and Sweden. In addition, national procedure is
ongoing in Iceland, Norway and Switzerland. Orion will announce further
information on approvals in these countries in its upcoming Interim Reports.

Orion's Easyhaler® is an in-house developed dry-powder inhaler. Orion has
developed Easyhaler-adapted dry powder formulations of several well-known
generic active substances (salbutamol, beclometasone, budesonide, formoterol)
used in the treatment of asthma and COPD. At the moment under development is
new combined formulation of fluticasone-salmeterol for the treatment of
asthma and COPD.

Orion Corporation

|Timo Lappalainen Olli Huotari |
|President and CEO |
| SVP, Corporate Functions |
Contact person:
Reijo Salonen, Senior Vice President, Research and Development, Orion
tel. +358 50 966 3647

Orion Corporation
Orionintie 1A, FI-02200 Espoo, Finland

Orion is a globally operating Finnish company developing pharmaceuticals and
diagnostic tests - a builder of well-being. Orion develops, manufactures and
markets human and veterinary pharmaceuticals, active pharmaceutical
ingredients and diagnostic tests. The company is continuously developing new
drugs and treatment methods. Pharmaceutical R&D focuses on central nervous
system drugs, oncology and critical care drugs, and Easyhaler® pulmonary

Orion's net sales in 2013 amounted to EUR 1,007 million and the company had
about 3,500 employees. Orion's A and B shares are listed on NASDAQ OMX


This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Orion Oyj via Globenewswire


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