BioWorld International Correspondent

BioTie Therapies Oyj signed an option agreement giving Somaxon Inc. North American rights to BioTie's drug for pathological gambling.

Turku, Finland-based BioTie would net $13.2 million in total from the deal, plus sales royalties, if the drug, an orally available formulation of nalmefene, completes clinical development.

BioTie gained $200,000 as an initial option fee and would net an additional $3 million on the activation of the full license agreement. That is contingent on FDA clearance to move nalmefene, an opioid receptor antagonist, into pivotal Phase III trials. The remaining $10 million is linked to development milestones.

A meeting with FDA officials has been scheduled in the fall, BioTie CEO Jari Saarinen told BioWorld International, and he is not anticipating any problems.

"We have a pretty good data package now, and specialists involved in the area are quite enthusiastic and supportive of this," he said. San Diego-based Somaxon's option runs until March 31, but Saarinen said he expects the agreement to be activated in the fall.

Nalmefene has completed a multicenter, placebo-controlled Phase II trial involving 200 subjects in the U.S. Efficacy was defined as a reduction in gambling-related thoughts and urges, as measured by the PG-YBOCS psychometric scale. Scores dropped in both arms of the study, but the decrease in the drug treatment group was twice that of the placebo group, and the difference was statistically significant.

An estimated 7.8 million people in the U.S. have a pathological relationship with gambling, BioTie said, and the company cites a statistic from the research firm Datamonitor indicating that 2.2 million have obtained a diagnosis and sought help. There are no approved drugs for the problem, which is instead dealt with through counseling. The novelty of a drug-based approach was a significant factor in determining the value of the agreement.

"The market has to be created, and that requires a lot of marketing spending," Saarinen said.

Current forecasts have the drug being launched around 2008, he said. An injectable form of nalmefene already has gained FDA approval for complete or partial reversal of opioid effects, including respiratory depression, induced by natural or synthetic opioids. BioTie also is developing its version as a treatment for alcohol addiction.

"We have done a Phase III study, and there we are also looking at partners," Saarinen said. In addition, the compound has potential application in the treatment of other compulsive disorders, including nicotine addiction and compulsive shopping.

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