Lundbeck has taken a step closer to filing for approval of nalmefene, its therapy for alcohol dependence, after reporting encouraging results in two Phase III studies.
Positive results from the ESENSE1 and SENSE trials - which included around 1,300 alcohol-dependent patients - have put nalmefene on track for a marketing authorisation application in Europe in the latter half of 2011, said Lundbeck. A third pivotal study (ESENSE2) rounds out the Phase III programme and is due to report data in the second quarter of this year.
The drugmaker has not divulged the actual results but said the data "demonstrate that nalmefene is the first potential treatment alternative for many people in need of a reduction of their total alcohol consumption."
Nalmefene acts by blocking a mechanism in the brain that causes a desire to drink, unlike currently available drugs that enforce abstinence by making patients ill when they consume alcohol.
The aims is to help patient reduce their alcohol intake towards safer levels, so endpoints in the studies include reduction in total alcohol consumption and the number of heavy drinking days in a month.
The news had an immediate positive impact on the Danish drugmaker's share price as investors welcomed the prospect of a new product to help offset the expected loss in revenues when Cipralex/Lexapro (escitalopram), Lundbeck's big-selling antidepressant, starts to see its patents expire in 2012-2014.
Escitalopram remains Lundbeck's top product with revenues a little under 2 billion kroner ($350m) in third-quarter 2010, around 54% of total group revenues, and the company has struggled to bring a successor through development. In 2009 it dropped antipsychotic bifeprunox and suspended development of bipolar disorder treatment Lu AA39959, and has also been forced to carry out additional trials of its new antidepressant Lu AA21004, setting back its filing date to 2012.
Nalmefene is not expected to replace lost Cipralex revenues on its own. Analysts are predicting peak sales could be as little as $60 million a year, held back by well-recognised difficulties in securing reimbursement for drug therapy for alcoholism.
It is however one of a number of late-stage programmes at the drugmaker, with others including clobazam for epilepsy (due to be filed in the USA shortly), desmoteplase for ischaemic stroke and intravenous carbamazepine for epilepsy Phase III.