Danish drugmaker Lundbeck has again boosted its late-stage pipeline and signed a deal to acquire the UK and Ireland rights to nalmefene, which will facilitate a future Europe-wide filing for the anti-alcoholism drug.
The agreement to get hold of the rights has been signed with Britannia Pharmaceuticals, a unit of Germany’s Stada Arzneimittel. Nalmefene was developed by Finland’s BioTie Therapies Corp which had previously sold licensing rights to Lundbeck for the drug in certain areas and this latest development means that Lundbeck now owns worldwide rights to the drug excluding North America, Mexico, Turkey and South Korea.
As a result of the UK and Ireland deal, BioTie said that its licensing deal with Lundbeck has been amended so that it is eligible for potentially 82 million euros in upfront and milestone payments, up from a previous maximum of 80 million euros, plus royalties. BioTie has already received an execution fee of 12 million euros from Lundbeck.
The intention now is to seek marketing authorisation for nalmefene simultaneously in all 27 European Union member states via the centralised procedure. To strengthen the existing registration dossier, Lundbeck is planning additional Phase III clinical studies this year before submitting the marketing authorisation application.
BioTie has already studied the safety and efficacy of nalmefene in a total of 1,200 patients, including two Phase III studies in the UK and Finland in people suffering from alcoholism and alcohol dependence. The firm says that nalmefene is the first oral drug showing efficacy in reducing heavy drinking in multicentre, controlled studies.
Timo Veromaa, chief executive at the Finnish firm, said that “Lundbeck now owning all of nalmefene rights in the EU is a very positive development indeed for BioTie”. This move “significantly facilitates EU-wide regulatory and marketing activities”, he added, noting that “we remain confident that nalmefene will generate significant revenues to the company in the long term”.
Success with nalmefene would also be great news for Lundbeck, which has recently stepped up its attempts to reduce its reliance on the antidepressant Cipralex/Levapro (escitalopram) which is facing generic competition in the next few years.
