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Biotie Therapies Corp. and Somaxon Pharmaceuticals, Inc. have announced that Somaxon has exercised its option to license nalmefene in North America. The companies signed a cooperation and option agreement on nalmefene in July 2004.

Under the terms of the agreement, BioTie has granted Somaxon 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. Somaxon intends to initially develop nalmefene for the treatment of pathological gambling in the United States and plans to initiate pivotal phase III clinical trials in 2005. Currently, there is no approved pharmacological treatment for pathological gambling in the United States.

Somaxon will pay BioTie USD 3 million as license fee and up to USD 10 million 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 USD 0.2 million in June 2004. Additionally, BioTie will receive royalty on sales of nalmefene in North America if approved by the FDA for indications, where BioTie has IPR protection, including pathological gambling.

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 U.S 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.

If approved by the FDA, it is the intention of Somaxon to market nalmefene to physicians who treat pathological gambling through its own sales organization or with a co-marketing partner which will allow the company to expand the product's use to the general practitioner. According to the agreement BioTie will get share of the revenues if nalmefene is sublicensed to a third party.

Nalmefene and pathological gambling (PG)

Pathological gambling represents a significant unmet medical need with no approved drug therapy available. It is estimated that in US alone 7.8 million people suffer from pathological gambling. Currently, 2.2 million patients are diagnosed and seek help for the treatment of PG (source: Datamonitor: Behavioural disorders 07/03). Psycho-social counselling is currently the main treatment modality for patients suffering from this condition.

Nalmefene and alcoholism

Alcoholism represents a significant unmet medical need with no approved "stand alone" drug therapy available. The present drug therapies are combined with psychosocial intervention. Nalmefene is the first drug therapy to show efficacy in controlled studies without a psychosocial intervention. Whereas all presently marketed pharmacotherapies for the treatment of alcoholism aim at complete abstinence, nalmefene is developed for the reduction of heavy drinking.

Biotie Therapies Corp.

BioTie Therapies is a Finnish biotech company with focus on dependence disorders, inflammatory diseases and thrombosis. BioTie's shares are listed on the Helsinki Exchanges (HEX). BioTie has been developing nalmefene for the treatment of alcoholism and pathological gambling since 1999.

For more information, visit

Somaxon Pharmaceuticals, Inc.

Somaxon Pharmaceuticals is a specialty pharmaceutical company focused on developing and commercializing products for the treatment of neuro-psychiatric diseases and disorders. Headquartered in San Diego, CA, Somaxon's lead clinical program is to evaluate SO-101, low-dose doxepin, for the treatment of insomnia. Currently SO-101 is in Phase II clinical trials. Somaxon actively seeks to license or acquire late stage development or marketed compounds in the areas of neurology and psychiatry.

For more information, visit or call 858/509-3670.
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Publication:Worldwide Biotech
Geographic Code:4EUFI
Date:Jan 1, 2005

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