Lundbeck is paying Paion €1.5 million (about $2.1 million) up front as part of the firms’ expansion to their current licensing agreement covering development of the latter’s Phase III-stage ischemic stroke candidate, desmoteplase. The new deal gives Lundbeck worldwide (excluding the U.S.) rights to develop and commercialize potential follow-on desmoteplase compounds identified by Paion. If one of the second-generation compounds reaches clinical development Paion will receive up to €25 million in milestones, plus double-digit sales royalties.
Desmoteplase is a plasminogen activator derived from a clot-dissolving protein found in the saliva of the vampire bat Desmodus rotundus. The drug is in development for the treatment of ischemic stroke up to nine hours after the onset of stroke symptoms. Lundbeck acquired worldwide rights to desmoteplase from Paion at the end of 2008, having held global non-U.S. rights to the drug since 2005. The firm has taken desmoteplase through two Phase II trials and an international Phase III study. The Phase III program is ongoing, and a Phase II trial for the Japanese market was started in March 2010. Paion retains an option to co-promote desmoteplase in Germany, Switzerland, and Austria.
The initial Phase III DIAS-2 study with desmoteplase failed to demonstrate any benefit of the drug over placebo. Subsequent analyses of the trial data found that there was an unexpectedly high, 46%, response rate in the placebo group. Further analysis of the results suggested that in comparison with previous Phase II desmoteplase trials, a large proportion (nearly three-quarters) of patients in DIAS-2 did not have visible arterial occlusion or high-grade stenosis at the time of study drug administration. Moreover, enrolled patients had a comparatively low baseline NIHSS (National Institute of Health Stroke Scale) score. Lundbeck says these differences in baseline characteristics were responsible for the unexpectedly high response in the placebo group.
The firm maintains pooled trial analysis has confirmed that the subgroup of patients with visible arterial occlusion or high-grade stenosis on baseline angiographies had improved response for desmoteplase over placebo.