H. Lundbeck

Lundbeck pulls the plug on its fast-tracked stroke drug December 18, 2014 Lundbeck is giving up on its efforts to develop desmoteplase as a treatment for stroke, as disappointing data have made it unclear just how to proceed. In two late-stage studies, desmoteplase proved itself safe and charted some positive results in patient subgroups, Lundbeck said, but its spotty efficacy made it difficult to determine how to pick patients for future studies. Now the Danish drugmaker is cutting its losses, taking a $51 million write-down and considering selling the drug outright. Desmoteplase, a treatment based on proteins found in bat saliva, had received the FDA's fast-track designation, promising a speedy trip through the regulatory process. More

Lundbeck discontinues development of desmoteplase for Ischaemic Stroke - 22-Dec-2014 H. Lundbeck A/S 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.