With this release, Orion Corporation updates information provided earlier on the Phase III clinical studies which are under way with dexmedetomidine, a sedative for patients in intensive care, with an aim to have the product registered in Europe as a long-term infusion, administered for over 24 hours. In these studies, the efficacy and safety of dexmedetomidine is compared with sedatives currently used in intensive care, i.e. midazolam in the MIDEX study and propofol in the PRODEX study, altogether in approximately 1,000 patients.
The programme, which was started in the summer of 2007, was originally estimated to last approximately two years. The recruitment of patients to the studies has proved to be slower than originally estimated, and it takes longer to complete the studies than projected earlier. Orion currently estimates that preliminary results from the trials will be available in the summer of 2010. Accordingly, the marketing authorisation application could be submitted by the end of 2010.
Dexmedetomidine is a proprietary medicinal substance originating from Orion's own alpha 2 receptor research. It is already available as Precedex in, for example, the USA and Japan as a sedative for patients in intensive care and administrable as an infusion for a maximum of 24 hours.
Timo Lappalainen Olli Huotari
President and CEO Senior VP, Corporate Functions
Reijo Salonen, SVP, Pharmaceutical R&D, phone +358 10 426 3647, gsm +358 50 966 3647
02200 Espoo, Finland
Orion is a European pharmaceutical and diagnostics company which emphasises the development of innovative medicinal treatments and diagnostic tests for global markets. Orion develops, manufactures and markets pharmaceuticals for humans and animals, active pharmaceutical ingredients as well as diagnostic tests. Orion's clientele consists mainly of healthcare service providers and professionals. The Group's net sales in 2007 were EUR 683.6 million and in the end of 2007 there were about 3,170 employees working for the Group. Orion's stocks are listed on the OMX Nordic Exchange Helsinki.