No relief for alcoholics yet after Lundbeck Phase III results
Prague/Turku/Copenhagen – Danish pharmaceutical company H. Lundbeck A/S yesterday unveiled clinical data on its potential blockbuster drug nalmefene at the 2012 European Congress of Psychiatry clinical in Prague. While Lundbeck and its Finnish partner Biotie Therapeutics Corp. from Turku underline an impressive 66% reduction in total alcohol consumption, a closer look at placebo data is disconcerting. In three placebo-controlled Phase III studies, the drug with the trade name Selincro was given to heavy drinkers who also were given medical advice about their drinking habits. Selincro aims at eliminating the brain's pleasure response to drinking. After six months, numbers of heavy drinking days (total alcohol consumption) in the first study dropped from 19 to 7 (84g to 30g) in the drug arm, and from 20 to 10 (85g to 43g) in the placebo arm. The numbers of the second study were less convincing and – even worse – in the third study the drug arm barely outperformed the placebo. Nevertheless Biotie-CEO Timo Veromaa thinks that "Selincro has the potential to transform the way alcohol dependence is managed by both patients and physicians." Right now, the flipped coin is in the air, not landing heads or tails until the review of the European application is out. But even if admission was granted, Selincro's success would remain at stake: According to analysts at Jefferies, the drug could reap up to $300 million in annual sales in Europe – not exactly a harvest of blockbuster dimensions. Also squinting at the US won't bring any sparkle to investors' eyes as there, the permitted market window for the drug would only be open for 5 years. Therefore, all eyes will be focussed on the follow-up Phase III data presented in June at the Annual Research Society on Alcoholism Scientific Meeting in San Francisco. In the meantime the coin's trajectory will be watched, closely.