Lundbeck alcohol dependence treatment Nalmefene reaches endpoints in pivotal Phase III study
Valby/Turku – Danish Lundbeck A/S yesterday said it will apply this year for the first European MAA for a treatment that helps drinkers to reduce their alcohol consumption, after its small molecule opioid receptor antagonist Nalmefene reduced alcohol consumption by more than 50% compared to pre-treatment baseline in a pivotal Phase III efficacy study. The drug is a 6-methylene structure analogon to Naltrexone, a drug already approved in the US, but with a different stability and safety profile. Nalmefene was originally developed by Key Pharmaceuticals and IVAX/Baker Norton and in-licensed in 2006 by Finnish Biotie Therapies Corp, which subsequently gave the global rights for the drug to Lundbeck in 2006. Under the terms of that agreement, Biotie is eligible for up to EUR 84 million in upfront and milestone payments plus royalties on sales from Lundbeck. Biotie has already received EUR 12 million from Lundbeck. Further milestone payments are expected on commercial launch of Nalmefene and on the product reaching certain predetermined sales. Lundbeck will be responsible for manufacturing and registration of the product. Biotie and Lundbeck had designed the efficacy trial on 718 alcohol-dependent people over 28 weeks to demonstrate that the 20 mg pills can reduce heavy drinking episodes and reduce overall alcohol consumption but not to keep patients from drinking. While the mechanism of action of Nalmefene and Naltrexone is not fully understood, it seems to modulate the dopaminergic meslimibs pathway which is thought to be linked to the reward associated with addiction. As long as the drinker takes a Nalmefene pill before treatment, craving and thus intake of dangerous amounts of alcohol is reduced.