Finnish drugmaker Orion Corp said yesterday that disappointing results from a Phase II trial assessing an oral formulation of its heart failure drug levosimendan mean that it will not go through to Phase III testing.
The aim of the PERSIST study was to assess the efficacy of orally-administered levosimendan, an intravenous version of which is already on the market under the tradename Simdax, but the results “did not show clear enough significance level for the primary endpoints,” explained the company in a statement.
This is certainly a disappointing turn of events for the firm, which just last month said that it is in talks with its partner, US drug giant Abbott Laboratories, about whether to carry out a third Phase III trial for the already marketed IV version.
Simdax is currently sold in more than 40 countries around the world, and Abbott holds rights to the drug in the USA as well as certain other countries around the world such as the UK, France and Germany where the drug is not yet approved.
But two Phase III clinical trials of Simdax reported last year - SURVIVE and REVIVE II - failed to show a significant improvement in survival in patients with heart failure, although there were some trends towards clinical improvements in patients on the drug.
Consequently, Abbott wants Orion to carry out - and fund - an additional study of Simdax, which suggests 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 in discussions with the Swedish regulatory authority, which will act as the reference member state for mutual recognition approval in the European Union.
Orion reported sales of Simdax of 4.3 million euros ($5.5m) in the first quarter of 2006, a 34% increase on the same period of 2005. For the whole of last year the company booked 13.7 million euros from the product.