Turku, Finland, November 12 (ots/PRNewswire)
- The Partnership Agreement on the First Indication (Pathological
Gambling) Could be Valued at up to USD 13.2 Million Plus Royalties
- Somaxon to Initiate a Phase III Clinical Development Program in
Biotie Therapies Corp. and Somaxon Pharmaceuticals, Inc. announced
today 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
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 organisation 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
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, please visit www.biotie.com
Somaxon Pharmaceuticals, Inc.
Somaxon Pharmaceuticals is a specialty pharmaceutical company
focused on developing and commercialising 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, please visit www.somaxon.com
ots Originaltext: Biotie Therapies Corp
Im Internet recherchierbar: http://www.newsaktuell.ch
Biotie Therapies Corp.: President and CEO Jari Saarinen, tel.
+358-40-500-4206, e-mail: email@example.com
Pharmaceuticals, Inc.: President and CEO Kenneth M. Cohen, tel.
+1-858-509-3670, e-mail: firstname.lastname@example.org