Orion seeks EU market authorisation for asthma/COPD product
Posted: 22 December 2016 | | No comments yet
Based on the results Orion is planning to apply for a marketing authorisation for the product in Europe. Orion currently estimates that the marketing…
Orion Corporation, a Finnish pharmaceutical and diagnostics company, has received favorable pharmacokinetic study results with combined salmeterol-fluticasone formulation of the Easyhaler product family.
Based on the results Orion is planning to apply for a marketing authorisation for the product in Europe. Orion currently estimates that the marketing authorisation application could be submitted in Europe during the first half of 2017.
Anti-inflammatory agent
Orion has developed a salmeterol-fluticasone formulation combining fluticasone as an anti-inflammatory agent and salmeterol as a long-acting bronchodilator to expand the range of the inhalable Easyhaler drug product family for treatment of asthma and COPD.
“We are extremely satisfied with the favourable results in a challenging development area. Salmeterol-fluticasone combination product will strenghten Orion’s Easyhaler drug product family that by utilising the same inhaler technlology offers diverse treatment options for treatment of asthma and COPD”, says Reijo Salonen, SVP, Orion Corporation.
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. The latest product that has been granted marketing authorisation is combined budesonide-formoterol formulation that has been launched in several European countries.
About Orion
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. The core therapy areas of Orion’s pharmaceutical R&D are central nervous system (CNS) disorders, oncology and respiratory for which Orion develops inhaled Easyhaler pulmonary drugs.
Orion’s net sales in 2015 amounted to EUR 1,016 million and the Company had about 3,400 employees. Orion’s A and B shares are listed on Nasdaq Helsinki.
