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 President and CEO | Olli Huotari SVP, Corporate Functions |
Contact person:
Reijo Salonen, Senior Vice President, Research and Development, Orion Corporation
tel. +358 50 966 3647
Publisher:
Orion Corporation
Communications
Orionintie 1A, FI-02200 Espoo, Finland
Homepage: www.orion.fi
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 drugs.
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 Helsinki.