Lundbeck and Otsuka to deliver psychiatric products


Danish firm will pay up to US$1.8bn to Otsuka

Danish pharmaceuticals group Lundbeck and Japanese drugmaker Otsuka Pharmaceutical have formed a global alliance to focus on delivering up to five innovative psychiatric and neuroscience products.

Lundbeck has gained co-development and co-commercialisation rights to Otsuka’s aripiprazole depot formulation in North and Latin America, Europe, Australia and some other countries, and to OPC-34712, which recently entered clinical phase III studies in schizophrenia and major depressive disorder.

Aripiprazole depot formulation has been developed to reduce the chance of reoccurrence of symptoms for patients who sometimes forget to take their medication as well as to enhance the convenience of medication with a once-monthly dosing.

The New Drug Application (NDA) for aripiprazole depot formulation will shortly be submitted to the US FDA, and Lundbeck expects that the Marketing Authorisation Application (MAA) will be submitted in Europe during 2013.

OPC-34712 is a novel investigational psychotherapeutic compound. It has entered into a clinical phase III trial for schizophrenia and adjunctive treatment of major depressive disorder (MDD).

With this collaboration Lundbeck says it will significantly expand its portfolio of psychiatry products and establish the firm within the US psychiatry community.

Under the terms of the agreement, Lundbeck will make an upfront payment of US$200m (approximately DKK1.1bn).

Otsuka will receive around US$1.4bn in total from Lundbeck in upfront payment and development and regulatory milestone payments. Both companies will share the sales as well as development and commercialisation costs based on the agreement.

With the addition of sales milestones in connection with products coming to the market, Lundbeck could pay up to US$1.8bn to Otsuka.

For aripiprazole depot formulation, Lundbeck will obtain 50% of net sales in Europe and Canada and 20% of net sales in the US from Otsuka.

For OPC-34712, Lundbeck will obtain 50% of net sales in Europe and Canada and 45% of net sales in the US from Otsuka.