Blow to Orion as deramciclane fails in Phase III anxiety studies

Orion Pharma of Finland and partner Pharmacia have decided todiscontinue the development of deramciclane for generalized anxiety disorder, owing to a lack of efficacy in the combined results of the Phase III trials of the agent. The two companies have been collaborating since the middle of 2001 on the drug, which was originally licensed from Hungary's Egis Pharmaceuticals.

News of the drug's demise, alongside what were considered weak financial results by analysts (see page 10), had a dramatic effect on Orion's share price on the Helsinki bourse, sliding 21% in mid-morning trading on February 18 to 15.80 euros. The statement came as something of a surprise, given that the company had reported the program as being on track as recently as its third-quarter 2002 results statement (Marketletter November 11, 2002).

In a statement, Orion and Pharmacia noted that the combined results from three Phase III studies conducted in Europe and the USA failed to show statistically-significant efficacy, although one of the two European trials, completed last fall, gave positive results. The compound had also been shown to exert anxiolytic effects in preclinical and Phase II clinical trials.