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Orion discontinues deramciclane studies in GAD due to lack of efficacy in Phase 3

 Due to the lack of efficacy as shown by the combined results from the Phase 3 clinical studies with deramciclane, an investigational compound studied in patients with generalised anxiety disorder (GAD), Orion Pharma and Pharmacia Corporation have decided not to continue the clinical trials programme with the compound. Pharmacia Corporation has been Orion's collaboration partner for the drug candidate since mid 2001.
The combined results from the three Phase 3 clinical studies conducted in Europe and the US failed to show statistically significant efficacy in patients treated with deramciclane. One of the two European studies completed last autumn gave positive results. The results from the latest study, subsequently conducted in the US, were pivotal in view of the conclusions.  The compound has been shown to exert anxiolytic effect in preclinical and clinical Phase 2 trials.
The indication, GAD, is a challenging psychiatric disorder to treat medically. There is a large unmet need to discover and develop a treatment with the ideal features for a first-line anxiolytic. Several investigational compounds have failed to meet the target profile combining high efficacy and few and tolerable side-effects.
- We are, of course, very disappointed with the results, says Dr. Risto Miettunen, President of Orion Pharma.  - The trials programme has been one of the largest in Orion's 20-year long research history, and great hopes were loaded in it. We now know that deramciclane is not an anxiolytic for humans. But, as a matter of fact, we do not know all about the compound yet. We shall possibly evaluate our opportunities to develop it for other indications, Dr. Miettunen says. 
Deramciclane is a selective 5-HT2 antagonist originally discovered by Egis Pharmaceuticals of Hungary, from whom Orion in-licensed the compound. Based on the collaboration agreement with Pharmacia, Orion has received around 39 million euros in signing fees and milestone payments, which partly compensate for the costs of the Phase 3 trials.
Orion Corporation
Jukka Viinanen                     Risto Miettunen  
President and CEO               Executive Vice President

Contact person:
Dr. Risto Miettunen, President, Orion Pharma, phone +358 10 429 4299.
Orion Corporation
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