Finnish pharmaceutical group Orion said this morning it posted a 13% increase in operating profit in the first half of 2006, driven by its drug business which made sales of 309 million euros, up 12%.
Overall sales at the group rose up 12% to 330 million euros, with top product Stalevo (carbidopa, levodopa and entacapone) – sold alongside partner Novartis – for Parkinson’s disease rising 56% to 55 million euros. The firm’s number two product, Comtess/Comtan (entacapone; also for Parkinson’s) added 10% to 40 million euros.
Combined sales of these products accounted for a third of Orion’s total turnover in the first half, and according to IMS data their combined market share was about 16% in the USA and 15% in Germany during the period. Orion also expects the franchise to gain momentum with the approval of Comtan in Japan, expected in the first half of next year.
Among Orion’s newer products Simdax (levosimendan) for heart failure brought in 7.6 million euros, a 4% gain on the prior year but down nearly 19% on the latter half of 2005. This product has suffered from continued reluctance by the US Food and Drug Administration to approve it for marketing – despite being available in more than 40 other countries – as well as a study reported late last year that found a trend towards a higher risk of death in heart failure patients treated with the drug, despite a clear benefit on symptoms.
Looking at its pipeline, Orion said that an ongoing Phase III trial (STRIDE-PD) of Stalevo is looking at whether the drug can delay the onset of symptoms in Parkinson’s disease patients. Results are expected in 2008.
Meanwhile, Orion has a Phase II trial underway for Precedex (dexmedetomidine) as a long-term infusion for the sedation of patients in intensive care. There was no news update on the development programme for levosimendan – partnered with Abbott Laboratories in the USA and certain European markets.
In May, Abbott said it wanted Orion to carry out – and fund – an additional study of Simdax, suggesting that it does not believe it will be possible to secure Food and Drug Administration (FDA) approval with the current data. In Europe, the US drugmaker is currently in discussions with the Swedish regulatory authority, which will act as the reference member state for mutual recognition approval in the European Union. Simdax is not yet approved in key European markets such as the UK, France and Germany.
