H. Lundbeck A/S Will Halt Studies Into Vampire Bat Saliva Drug
December 18, 2014
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Danish biopharmaceutical firm Lundbeck A/S (Lundbeck) has tongues wagging on Wall Street Thursday, after it announced that it would pull the plug on future research into its experimental stroke drug compound desmoteplase, despite two previous studies showing positive patient effects and fast-track designation from the U.S. Food and Drug Administration (FDA) for the treatment of acute ischaemic stroke.
Deepening suspicion was the news that Lundbeck would take a write down of $51.26 million for the fourth quarter of 2014, despite giving no other info on the stoppage except that it was “insufficiently clear how to select patients in future prospective studies.”
“Lundbeck has decided to cease further development in ischaemic stroke,” said the company in a statement. “Alternatives including divestiture are now being evaluated.”
The company said the news meant a narrowed guidance range, with a core EBIT of 1.1 billion-1.3 billion crowns versus previously expected 0.9 billion-1.4 billion crowns. It will also only have 2014 reported EBIT of 0-0.2 billion crowns compared to previously expected 0-0.5 billion crowns for 2014.
Lundbeck said in a terse statement that it would continue looking for alternative ways to study the drug, which is a genetically engineered version of a clot-dissolving protein found in the saliva of the vampire bat Desmodus rotundus. Desmoteplase is what’s known as a fibrin-dependent plasminogen activator, meaning it helps dissolve clots rapidly, a huge boon to clinicians treating stroke patients where every minute of time with reduced blood flow to the brain means lost muscle.
“In both the DIAS-3 and DIAS-4 study patient sub-groups experienced positive effects and the studies confirmed the favorable 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.”