BioTie in licensing agreement with Somaxon Pharmaceuticals

Published: 12-Nov-2004

Finnish biotech company Biotie Therapies Corp. has granted US company Somaxon Pharmaceuticals an exclusive license in North America to clinically develop, manufacture and market nalmefene for the treatment of impulse control disorders, alcoholism and alcohol abuse and nicotine dependence.


Finnish biotech company Biotie Therapies Corp. has granted US company Somaxon Pharmaceuticals an exclusive license in North America to clinically develop, manufacture and market nalmefene for the treatment of impulse control disorders, alcoholism and alcohol abuse and nicotine dependence.

The companies signed a cooperation and option agreement on nalmefene in July 2004.

Somaxon intends to develop nalmefene initially for the treatment of pathological gambling in the US and plans to initiate pivotal phase III clinical trials in 2005.

Somaxon will pay BioTie a licence fee of US$3m and up to $10m in milestone payments for the lead indication, pathological gambling, subject to achieving certain development milestones. BioTie will receive additional milestone payments if nalmefene is developed for additional indications. Somaxon has already paid BioTie an option fee of $200,000 in June 2004.

Nalmefene is a specific and selective opioid receptor antagonist, which has demonstrated good safety and efficacy in a phase II clinical study in the US in patients diagnosed with pathological gambling disorder and in two phase III studies in the UK and in Finland in patients suffering from alcoholism and alcohol abuse.

BioTie holds exclusive US rights for the use of opioid receptor antagonists in impulse control disorders, including pathological gambling, and holds several other patents and intellectual property rights on nalmefene and its use in US, Europe, and Japan for the treatment of alcohol abuse.

  

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