PhIII placebo response complicates Lundbeck's case for anti-drinking drug

Lundbeck has taken the wraps off its Phase III data for the alcohol dependence drug nalmefene. And while its partner, Biotie, stoutly maintains the drug's "significant" edge over a placebo in reducing alcohol intake, the pharma company will likely have plenty of explaining to do before it can gain European approval for the drug--or a commitment on the part of stingy payers to cover the therapy.

Nalmefene, christened Selincro for commercial purposes, has been repeatedly cited as a potential blockbuster by the company, which believes it's on track to gain an approval for the first treatment to counter heavy drinking. Biotie's release spotlights an impressive 66% reduction in total alcohol consumption. But the treatment--which is designed to eliminate the brain's pleasure response to drinking--doesn't fare so well when you shift from percentages to numerical comparisons with a placebo.

In one trial the drug was linked with a drop in the number of heavy drinking days from 19 to 7, with total alcohol consumption sliding from 84g to 30g after 6 months. In the placebo arm binge drinking days slid from 20 to 10 and total alcohol consumption dropped from 85g to 43g. In a separate study, heavy drinking days slid from 20 to 7 while consumption dropped from 93g to 30g, while the placebo group registered an 18 to 7-day drop in drinking days and an 89g to 33g drop in consumption. In a third study, the drug arm barely edged the placebo at 6 months. All the subjects in the trial were given medical advice about their drinking habits.

"The results presented today reinforce the efficacy and safety of Selincro in patients with alcohol dependence," maintained Timo Veromaa, the CEO of Biotie, which is partnered on the drug. "Selincro has the potential to transform the way alcohol dependence is managed by both physicians and patients and we look forward to working with our partner Lundbeck and the regulators to make this important new treatment option available in Europe."

Analysts at Jefferies, however, weren't as optimistic, noting that the numbers could complicate Lundbeck's European application, which is under review. They also aren't likely to do much for peak sales projections. Bloomberg notes that Jefferies believes the drug can rack up as much as $300 million in annual sales at the top end, if it is approved. That is far below the blockbuster potential Lundbeck has seen for a treatment it considers one of its top prospects.

Further limiting the drug's potential: Lundbeck won't be making a case for the drug in the U.S., where it could only hope for a 5-year market window. None of that is likely to encourage analysts, who have been frowning at Lundbeck's efforts to counter the effects of upcoming generic competition for Lexapro.

- here's the press release
- here's the Bloomberg report

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