Otsuka Pharmaceutical Co., Ltd. (Otsuka), a global healthcare company with the corporate philosophy and H. Lundbeck A/S (Lundbeck), an international pharmaceutical company highly committed to improving the quality of life for people suffering from CNS disorders, signed an agreement during a ceremony held on November 11, 2011 at Tokushima City in Tokushima, Japan, for the development and commercialization of up to five innovative psychiatric and neuroscience products worldwide.

The agreement covers up to five early and late stage compounds in development. The two late stage compounds are from Otsuka: aripiprazole depot formulation and OPC-34712. Otsuka receives the rights to enter into co-development, and eventual co-promotion following approval, of up to three compounds after phase IIb clinical trials.

The alliance is a sales and cost share agreement. Under the terms of the agreement, Lundbeck will make an upfront payment upon signing of USD 200 million. Otsuka will in total receive up to approximately USD 1.4 billion from Lundbeck as upfront payment and development and regulatory milestone payments. With the addition of sales milestones in connection, Lundbeck will pay up to approximately USD 1.8 billion to Otsuka. Both companies will share the sales and development and commercialization costs based on the agreement.

For aripiprazole depot formulation, Lundbeck will receive 50% of net sales in Europe (EU5 and the 4 Nordic countries) and Canada and 20% of net sales in the US from Otsuka. The cost incurred for the development and promotion will be shared in the same ratio. Otsuka holds the rights in many of the Asian countries including Japan, as well as Turkey and Egypt. For the remaining markets in the Lundbeck territories, Lundbeck will market the compound and Otsuka will supply the bulk product at a price of agreed percentage of the sales.

For OPC-34712, Lundbeck will receive 50% of net sales in Europe (EU5 and the 4 Nordic countries) and Canada and 45% of net sales in the U.S. from Otsuka. The cost incurred for the promotion will be shared in the same ratio. Otsuka holds the rights in many of the Asian countries including Japan, as well as Turkey and Egypt. For the remaining markets in the Lundbeck territories, Lundbeck will market the compound, and Otsuka will supply the bulk product at a price of agreed percentage of the sales. For the development costs of OPC-34712, Otsuka will be responsible up to certain amount and equally share the costs afterwards.

In co-commercialization countries, the parties will share sales efforts and costs in accordance with the territory split. In the U.S., Canada, EU5 and the 4 Nordic countries, Otsuka will book all sales. In the rest of Europe and the world, excluding many of the Asian countries, as well as Turkey and Egypt, Lundbeck will book all sales and take full responsibility for commercialization. Otsuka will retain the rights to participate in the co-development and co-marketing when it establishes a sales organization in Lundbeck’s territory.

Otsuka brings a strong presence in the North American and Asian CNS markets, and Lundbeck complements Otsuka’s position with a strong presence in Europe. Combined, both companies reach most of the global CNS market.

“We are very excited that Otsuka and Lundbeck have entered into a co-development and co-commercialization agreement for aripiprazole depot formulation and OPC-34712, both potential key drivers of future growth for Otsuka’s CNS business,” said Dr. Taro Iwamoto, president and representative director, Otsuka Pharmaceutical Co., Ltd. “Lundbeck’s expertise in developing depression and anxiety treatments and Otsuka’s expertise in developing anti-psychotics will maximize the medical and commercial value of Otsuka’s portfolio in CNS. In addition, our partnership with Lundbeck will enable us to establish a strong platform to deliver these compounds to patients who need them in Europe, South America, Oceania, BRICs and around the world. Our collaboration will lead to the next generation of innovation by co-developing Lundbeck’s three new compounds.”

"We are very pleased to have entered into this collaboration with Otsuka,” said Ulf Wiinberg, president & chief executive officer, Lundbeck. “With the addition of aripiprazole depot formulation and OPC-34712, Lundbeck has significantly broadened its growing psychiatry portfolio with an exciting and unique potential treatment in an area of high unmet need. This collaboration allows us to be introduced to the US psychiatry community as soon as 2013."
About Aripiprazole Depot Formulation

Aripiprazole depot formulation is a sterile, lyophilized cake that when reconstituted with sterile water for injection, forms an injectable suspension. This formulation has been evaluated as a once-monthly injection for the maintenance treatment of schizophrenia.

Otsuka’s Aripiprazole Intramuscular Depot Study in Schizophrenia-US is a phase III clinical study of the depot formulation of aripiprazole that was designed to evaluate the efficacy, safety and tolerability of the intramuscular formulation as a maintenance treatment in patients with schizophrenia. The US registrational study (31-07-246) was a multicenter, randomized, double-blind, placebo-controlled study, originally scheduled for a 52 week duration, that incorporated an interim analysis after achievement of 50% of the 125 events needed to complete the study. This interim analysis was conducted in June, 2010 and the independent data monitoring committee determined that the interim analysis met the established termination criteria and recommended that the study be stopped.
About OPC-34712

OPC-34712 is a novel investigational psychotherapeutic compound developed to potentially provide improved efficacy and tolerability over established therapies for the treatment of schizophrenia and the adjunctive treatment of major depressive disorder (MDD). The compound has broad activity across multiple monoamine systems including partial agonist activity at D2 dopamine receptors and enhanced affinity for specific serotonin receptors. OPC-34712 is currently in clinical phase III testing for schizophrenia and adjunctive treatment of MDD.