H. Lundbeck A/S’s Selincro, the first treatment to help people cut back on drinking without abstaining, won the backing of the European Union’s drug regulator.
Selincro is recommended for men who drink more than 60 grams of alcohol a day and for women who consume more than 40 grams daily, the European Medicines Agency said in a statement today. Sixty grams would be equal to the alcohol content of about one and a half bottles of wine, Lundbeck said.
The drug works to reduce the urge to continue drinking by blocking brain signals that make drinking feel good. Selincro is designed to help alcohol-dependent people cut back, an approach that divides treatment experts because many advocate abstinence. It should be prescribed in conjunction with “continuous psychosocial support that focuses on treatment adherence and reducing alcohol consumption,” the agency said.
Lundbeck fell 0.8 percent to close at 98.2 kroner in Copenhagen, where the company is headquartered. Turku, Finland-based Biotie Therapies Oyj, which licensed the drug to Lundbeck, rose 2.3 percent to 44 cents in Helsinki.
In studies, patients were instructed to take one tablet one or two hours before the anticipated time of drinking. In one late-stage trial, monthly total alcohol consumption fell from 75 grams per day on average to 16 grams per day after one year of treatment, Lundbeck said. Mild side effects, such as insomnia and nausea, decreased over the course of treatment, it said.
Lundbeck is targeting the European market, where annual per capita alcohol consumption, at 12.18 liters (3.2 gallons), is double the global average and 40 percent higher than in the Americas, according to the World Health Organization. It hasn’t yet sought approval in the U.S., where it would be protected from generic competition for only five years, compared with 10 years in Europe, according to the company.
A harmful level of drinking is associated with premature death and is a major risk factor for psychiatric disorders, heart disease, cirrhosis of the liver and cancer, the EMA said.
The agency’s recommendations are the final stage before the European Commission, the EU’s executive arm, approves or rejects a drug for sale to patients in the 27-nation region. The commission usually follows the EMA’s recommendation.
Once the drug has been introduced in Europe and doctors and patients gain experience using it, Lundbeck may open up discussions with regulators in other countries such as the U.S., Japan, South Korea, and China, Chief Executive Officer Ulf Wiinberg said in an interview on Dec. 5.
While sales may reach 400 million kroner ($70 million) in 2016, success will depend on Lundbeck’s ability to work with governments in gaining reimbursement and publicly funded awareness campaigns, said Tim Race, a London-based analyst at Deutsche Bank, in a note to investors today.
Lundbeck plans to submit Selincro to Russian regulators in the first half of 2013, said Andreas Eggert, who oversees commercializing the drug. Biotie may receive as much as 84 million euros ($110 million) in payments from Lundbeck in addition to royalties on sales.