Breaking out the champagne may not have been the appropriate reaction, but Biotie Therapies Oyj had reason to celebrate Friday, as the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended approval for its alcohol dependence drug Selincro (nalmefene). Formal European Commission approval should follow in February, paving the way for a commercial launch shortly thereafter.

H. Lundbeck A/S, Biotie's development partner, said it plans to launch the product in a number of European markets in mid-2013. It is in the company's interests to begin selling the product soon after the commission approval comes through.

"The 10-year market exclusivity starts ticking from the formal commission decision," Biotie CEO Timo Veromaa told BioWorld Today.

The launch will trigger a milestone payment to Turku, Finland-based Biotie. A total of €89 million (US$117 million) in milestone payments are attached the deal, €12 million of which Biotie has already received, as well as sales royalties. Biotie will provide financial guidance once the formal Commission decision is made, which generally occurs 67 days after the CHMP opinion.

The companies have yet to see the full product label, but there were "no surprises" in the CHMP decision. "There is no restriction on what kind of physician can prescribe this," he said. "It's amenable to be prescribed by both specialists and GPs." The summary of the CHMP opinion stated that the drug "should only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption."

Lundbeck may seek a partner in order to reach GPs. "They do recognize that to have a full impact in launching the product, it would greatly benefit from having a large sales force targeting GPs," he said.

Selincro, an opioid receptor antagonist, works by disrupting the normal brain reward system associated with alcohol consumption. It is positioned as an aid to reducing consumption, rather than eliminating it entirely.

It demonstrated a small, but statistically significant advantage over placebo in a Phase III program that recruited 2,000 patients. Those who received the drug reduced their heavy drinking days by 2.3 per month in one trial and by 1.7 per month in a second, as compared with placebo. Total alcohol consumption dropped by an average of 11 grams per day in the first trial and by 5 grams per day in the second, as compared with placebo. The most frequent adverse events included dizziness, insomnia and nausea.

The drug is indicated for men who consume more than 60 g of alcohol per day and for women who consume more than 40 g of alcohol per day. It is taken as needed – when patients perceive they are at risk of drinking excessively on a particular day.

The biggest challenge facing the companies will be to build a market where there is none at present. "Physicians are conservative by nature. It will take some time for them to notice they can now do an intervention," Veromaa said.

Patient acceptance is less likely to be a problem. "It's a very, very high hurdle to go into Alcoholics Anonymous and other forms of intensive counseling," he said.

Selincro, which Biotie in-licensed in the late 1990s from Ivax Corp. (now part of Teva Pharmaceutical Industries Ltd., of Petah Tikvah, Israel) has a long history, and its composition-of-matter patents have expired, although Lundbeck and Biotie jointly hold a patent on a salt formulation of the drug.

Because the U.S lacks similar market exclusivity provisions, Lundbeck has not sought approval there as yet. An unfavorable regulatory regime is another factor. "One has to remember the FDA has been staunchly opposed to any risk mitigation strategies in addiction," Veromaa said. "We see it's beginning to change," he added, noting discussions other drug developers have had with the agency.

Biotie shares (HELSINKI:BTH1V) rose 16 percent to peak at €0.50 in response to the news, but many investors took some profit. The stock closed at €0.44, a gain of 1 cent. The stock is up 15 percent over the past week. The company disclosed last Tuesday that its Parkinson's disease drug tozadenant (SYN115), which it is co-developing with UCB SA, of Brussels, Belgium, hit the primary endpoint of a Phase IIb trial. (See BioWorld International, Dec. 12, 2012.)