Valby, Denmark, 17 December 2014 - H. Lundbeck A/S (Lundbeck) today announced that following the evaluation of the entire available data package including results from DIAS-4 on the investigational compound desmoteplase, Lundbeck has decided to cease further development in ischaemic stroke. Alternatives including divestiture are now being evaluated.
In both the DIAS-3 and DIAS-4 study patient sub-groups experienced positive effects and the studies confirmed the favourable safety profile of desmoteplase by indicating good safety and tolerability data. It was, however, insufficiently clear how to select patients in future prospective studies. It has therefore been decided to discontinue the development project in Lundbeck.
Following this decision a write-down of DKK 309 million will be taken in the fourth quarter of 2014 and recognized in the R&D costs as communicated earlier this year.
The content of this release will have some influence on the Lundbeck Group's financial guidance reported operating profit (EBIT) for 2014.
For the fiscal year 2014, Lundbeck is still expecting constant currency revenue to be around DKK 13.5 billion.
Lundbeck now expects core profit from operations (core EBIT) in constant currency to be in the range DKK 1.1-1.3 billion versus previously DKK 0.9-1.4 billion for 2014. Expected reported profit from operations (EBIT) in constant currency is now expected at DKK 0-0.2 billion compared to previously at DKK 0-0.5 billion for 2014.
Desmoteplase, a fibrin-dependent plasminogen activator, is a genetically engineered version of a clot-dissolving protein found in the saliva of the vampire bat Desmodus rotundus. It has received fast-track designation from the U.S. Food and Drug Administration (FDA) for the treatment of acute ischaemic stroke.