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Agreements

Date: 2012-09-07

Type of information: Commercialisation agreement

Compound: Selincro™ (nalmefene)

Company: Lundbeck (Denmark) Biotie Therapies (Finland)

Therapeutic area:

Type agreement:

commercialisation
distribution

Action mechanism:

Nalmefene is a selective opioid receptor ligand with antagonist activity at mu and delta opioid receptors and partial agonistic activity at the kappa opioid receptor. This pharmacological profile helps to control and reduce alcohol intake.

Disease: alcohol dependence

Details:

Lundbeck has announced that it has amended its Selincro™ licensing agreement with Biotie Therapies. The danish pharmaceutical group has also acquired an equity stake (€10 million) in Biotie. It has subscribed for 18,604,651 shares in Biotie at a subscription price of € 0.5375 per share representing less than 5% of the total equity capital in Biotie. In connection with this transaction, to facilitate the potential launch of Selincro™ (nalmefene) outside of Europe, the royalty rates on Selincro™ in countries outside Europe and the US have been reduced. However, Biotie is to receive an additional sales milestone following the achievement of an undisclosed sales target in Japan, increasing the total milestone package to € 89 million from previously € 84 million.

Lundbeck holds worldwide development and commercialisation rights to Selincro™, a novel opioid system modulator for the treatment of alcohol dependence. Lundbeck has filed a marketing authorization application for Selincro™ in the EU with European Medicines Agency (EMA) and a decision on potential approval is expected in the fourth quarter of 2012.

Financial terms:

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Is general: Yes