Lundbeck is paying Otsuka Pharmaceuticals $200 million up front as part of a potentially $1.8 billion worldwide alliance to develop and commercialize up to five psychiatric and neurology products. The deal includes the Japanese firm’s late-stage schizophrenia and/or major depressive disorder (MDD) candidates aripiprazole depot formulation and OPC-34712 plus three Lundbeck compounds.
Otsuka will receive up to $1.4 billion as up front and development and regulatory milestones and could earn another $0.4 billion in sales and related payments. It also retains the right to opt into co-development and co-promotion of up to three compounds, once Phase IIb studies have been completed.
For the aripiprazole depot formulation, Lundbeck will receive 50% of net sales in Europe (EU5—France, Germany, Italy, Spain, and U.K.—and the four Nordic countries) and Canada and 20% of net sales in the U.S. from Otsuka. Development and promotion costs associated with the product will be shared by the firms at the same ratio.
Otsuka will retain rights to the drug in a number of Asian countries including Japan along with Turkey and Egypt. For the remaining markets in Lundbeck’s territories the Danish company will market the product, which will be supplied at a set price by Otsuka.
With respect to OPC-34712, Lundbeck will again receive 50% of net sales in Europe (EU5 and the four Nordic countries) and Canada but 45% of net sales in the U.S. from Otsuka. Otsuka will be responsible for a certain level of development costs associated with OPC-34712, after which the firms will share the costs equally.
Promotion costs will be shared at the same ratio. Otsuka will also hold rights to the drug in a number of Asian countries including Japan as well as Turkey and Egypt, with Lundbeck marketing the compound in its designated territories, and Otsuka supplying the bulk products.
In co-commercialization countries the firms will share sales efforts and costs according to the split in that territory. In the U.S., Canada, EU5, and four Nordic countires, Otsuka will book all sales. In the rest of Europe and the world (excluding Otsuka’s Asian countries, Turkey, and Egypt), Lundbeck will book all sales and shoulder all commercialization responsibilities. Otsuka has rights to join in with the co-development and co-marketing when it establishes a sales organization in Lundbeck’s territory.
The schizophrenia candidate aripiprazole depot is once-monthly injectable formulation of Otsuka’s marketed drug Abilify® . The depot formulation has successfully completed a Phase III study in the U.S., which was stopped early at interim analysis due to meeting its established termination criteria.
OPC-34712 is designed to have broad activity across multiple monoamine systems, including partial agonist activity at D2 dopamine receptors, and enhanced affinity for specific serotonin receptors. The drug is in Phase III as a treatment for schizophrenia and the adjunctive treatment of MDD.
Abilify is Otsuka’s biggest selling antipsychotic drug. It co-markets Abilify in partnership with Bristol-Myers Squibb. The drug is reportedly marketed in over 65 countries and achieved net sales of $4.5 billion in 2010. Sales of the drug accounted for 33.6% of parent firm Otsuka Holdings’ consolidated results for the year.
Lundbeck’s CNS portfolio includes the antidepressant Cipralex/Lexapro, the Alzheimer disease drug Ebixa, Azilect for the treatment of Parkinson disease, Xenazine for treating Huntington disease chorea, the schizophrenia drug Serdolect, and the epilepsy therapy Sabril. Lexapro is the firm’s biggest selling product, with global sales sitting at about $4 billion, the firm says.