Finnish pharmaceutical firm Orion Group has suffered a major setback after its US partner Abbott Laboratories informed the Helsinki-based firm that it is to discontinue development in the USA of Simdax for heart failure.
The US drug major said that further development of Simdax (levosimendan) is not “commercially reasonable” and so will not conduct the Phase III trials required for the drug to get the go-ahead in the USA. Despite being available in over 40 countries (though not yet in key European markets such as the UK, France and Germany), the Food and Drug Administration had insisted on further studies.
In February, Orion said that after talks with Abbott, it was considering contributing 20 million euros to the cost of an additional Phase III study with intravenously administered levosimendan but this offer would not appear to have been enough to keep Abbott on board. No further information about the possibility of such a study going ahead was disclosed.
Orion profits decline
Meantime, Orion has posted a 2.9% decline in operating profit for the first quarter to 61.1 million euros, while sales rose 3.2% to 179.2 million euros. Once again sales were driven by its Parkinson's disease drug Stalevo (carbidopa, levodopa and entacapone) - sold with partner Novartis - which increased 3% to 33 million euros. However, its second-best seller, also for Parkinson's, was Comtess/Comtan (entacapone) which brought in 21.6 million euros, down 2.6%, while Simdax sales fell 18% to 3.5 million euros.
As for the pipeline, Orion said that an ongoing Phase III trial of Stalevo is looking at whether the drug can delay the onset of symptoms in Parkinson's disease patients and results from the 14-country study are expected in the first half of 2008. A Phase III study looking at Precedex (dexmedetomidine) as a long-term infusion for the sedation of patients in intensive care is also underway, with a view to a filing in Europe. The product is already available in the USA and Japan as a sedative for patients in intensive care, administrable for up to 24 hours.