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H. Lundbeck A/S (LUN), the Nordic region’s second-largest drugmaker, said its anti-alcoholism treatment nalmefene helped patients cut consumption by an average of 66 percent in three clinical trials.
Results of the final stage of clinical trials showed nalmefene helped curb drinking more than a placebo and medical advice, Lundbeck said in a presentation at a medical meeting in Prague today. Nalmefene users reported a 64 percent to 79 percent drop in total alcohol intake, compared with 49 percent to 64 percent for those on placebo, Copenhagen-based Lundbeck said.
Heavy drinking is Europe’s second-largest risk factor for poor health. Lundbeck plans to offer nalmefene as a treatment option to those who suffer from alcohol dependency and are turned off by abstinence, which is advocated by most experts, said Anders Gersel Pedersen, head of Lundbeck’s research and development. About 70 percent of patients who enrolled in the clinical trials for nalmefene had never received treatment, Pedersen said in a telephone interview.
“It changes the whole paradigm around the conversation about alcohol use between the physician and the patient,” he said.
Lundbeck submitted nalmefene, which may become the first new medicine sold to treat heavy drinking in more than 15 years, to the European Medicines Agency in December based on the research. A decision on the drug from the European regulator probably will come in the beginning of next year, Pedersen said.
Lundbeck fell 0.7 percent to 117.10 kroner in Copenhagen. Shares of Turku, Finland-based Biotie Therapies Oyj (BTH1V), which licensed nalmefene to Lundbeck, rose 2 percent to 52 euro cents in Helsinki. If the product is cleared, Biotie may receive as much as 84 million euros ($111 million) in payments from Lundbeck in addition to royalties on sales.
Patients taking nalmefene had high withdrawal rate in one of the three late-stage studies, mostly because of adverse events, Danske Markets analysts attending the Prague meeting wrote today in a note to investors. In the six-month Esense 1 trial, only 142 of 302 patients on the drug completed the study, compared with 205 of 296 patients taking placebo, the analysts said. The most frequent adverse events were dizziness, insomnia and nausea, Lundbeck said.
Those who stayed on the medication reported 63 percent fewer heavy drinking days and a 64 percent reduction in total alcohol consumption, the analysts wrote.
“This is quite a substantial difference,” they said.
While the differences between drinkers taking nalmefene and those getting a placebo were statistically significant, the results didn’t show a huge numerical difference, Jefferies International Ltd. analysts led by Peter Welford wrote in a note to investors today.
Patients who received a placebo and medical advice had a 50 percent reduction in heavy drinking days and total alcohol consumption in the Esense 1 trial, according to Lundbeck. In the six-month Esense 2 study, nalmefene users cut their heavy drinking days by 65 percent, compared with 61 percent in the placebo group. Total alcohol consumption fell 68 percent among those taking the drug, compared with a 63 percent decline for the placebo group.
“This should be as expected given the medical advice available to all patients in the trials, and perhaps illustrates an important placebo-effect of a treatment” such as this “being made commercially available,” Welford and his colleagues wrote. “Nevertheless, this could complicate regulatory discussions.”
A third study, dubbed Sense, followed patients for 12 months and found nalmefene users had about an 80 percent reduction in both heavy drinking days and total alcohol intake, compared with 60 percent and 64 percent declines, respectively, in the placebo group, Lundbeck said.
Lundbeck is targeting Europe for nalmefene, where annual per capita 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. The drug will be marketed under the name Selincro.
Alcohol abuse results in 2.5 million deaths each year, more than those caused by AIDS or tuberculosis, according to the Geneva-based WHO. The highest proportion of alcohol-related mortality is in Russia and neighboring countries, where every fifth death results from alcohol abuse.
“This is a potential revolution,” said David Nutt, professor of neuropsychopharmacology at Imperial College London, said in an interview before the study results were released. “Some people, like Alcoholics Anonymous, will be completely against it. But others will welcome it as a way to control their drinking.”
Nutt calls nalmefene a “drinking regulator” that would be “cheaper than getting drunk.” He has received grants or fees for consulting or speaking from drugmakers involved in addiction treatment including Lundbeck, though he didn’t play a role in any research on nalmefene.
The drug may have peak sales of $55 million, assuming 10 percent of diagnosed European patients take it, though revenue could reach $300 million, the Jefferies analysts estimated. Higher sales would require a partnership to sell the drug to general practitioners, or promotional support from governments seeking to improve public health, the analysts said.
Lundbeck is aiming to form a marketing partnership once the labeling of nalmefene has been defined with the European Medicines Agency, Pedersen said. Nalmefene won’t be sold in the U.S., where it would be protected from generic competition for only five years, compared with 10 years in Europe, Lundbeck Chief Financial Officer Anders Gotzsche said in a November interview.
Nalmefene works by blocking brain signals that make activities such as sex and drinking feel good. Patients on the medicine can continue drinking, an approach that divides alcohol treatment experts because many advocate abstinence.
Existing therapies include the generic drug Antabuse, also known as disulfiram, and Forest Laboratories Inc. (FRX)’s Campral and are generally used to help patients who have abstained from resuming drinking. Antabuse causes illness when alcohol is consumed, while Campral eases symptoms of withdrawal, such as anxiety and insomnia.
Lundbeck’s biggest seller is the antidepressant Lexapro, sold outside the U.S. as Cipralex. The drug generated 8.5 billion kroner ($1.5 billion) in worldwide sales last year and 581 million kroner in the U.S., where the patent expires in 2012.
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