Biotie licenses nalmefene to H Lundbeck

Danish drugmaker H Lundbeck AS has licensed the worldwide rights for nalmefene HCl from Finnish drug development company Biotie Therapies for the treatment of substance abuse and impulse control disorders. As part of the deal, Lundbeck gains exclusive marketing and distribution rights to the specific and selective opioid receptor antagonist for all territiories excluding North America, Mexico, the UK, Ireland, Turkey and South Korea.

Under the terms of the agreement, BioTie will receive an execution fee of 15.0 million euros ($19.7 million), of which 10.0 million euros is payable on signing. In total, the Finnish firm is eligible to receive up to 88.0 million euros in upfront and milestone payments plus royalties on sales. Lundbeck will be responsible for manufacturing and registration of the product in its territories.

BioTie recently submitted the first Marketing Authorization Application on nalmefene for the treatment of alcohol dependence to the Medicines and Healthcare products Regulatory Authority in the UK, which will act as the reference state in the Mutual Recognition Process for European Union approval.