Desmoteplase endgültig am Ende
24.12.14 10:59
#1
ellogo2
Desmoteplase endgültig am Ende
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.
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.
24.12.14 11:02
#2
ellogo2
info
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
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