12:00 AM
Dec 05, 2011
 |  BioCentury  |  Strategy

Lundbeck psyched up

Otsuka deal gives Lundbeck foothold in U.S. in psychiatry field

H. Lundbeck A/S's deal with Otsuka Pharmaceutical Co. Ltd. for two late-stage programs is designed to take the Danish pharma beyond replacing patent-related revenue losses, giving it products to establish a foothold in the U.S. psychiatry market in advance of launching its own depression drug.

In November, the companies partnered to co-develop and co-commercialize two late-stage programs from Otsuka and up to three programs from Lundbeck. The deal includes Otsuka's once-monthly depot formulation of aripiprazole for maintenance treatment of schizophrenia, which FDA accepted for review on Nov. 22. The PDUFA date is undisclosed.

Otsuka and U.S. partner Bristol-Myers Squibb and Co. market the once-daily Abilify aripiprazole for a variety of psychiatry indications. The product is an oral form of the small molecule partial agonist of the dopamine D2 and serotonin (5-HT1A) receptors and antagonist of the 5-HT2A receptor.

The Lundbeck deal also includes Otsuka's OPC-34712, a partial agonist of the dopamine D2 receptor with affinity for multiple serotonin receptors. The compound is in Phase III testing to treat schizophrenia and as an adjunct for major depressive disorder (MDD).

Lundbeck received rights in North America, Latin America, Europe, Australia and undisclosed countries. Otsuka retains rights in Turkey, Egypt and many Asian countries, including Japan.

The partners are still discussing which Lundbeck programs will be included; however, President and CEO Ulf Wiinberg told BioCentury one will be zicronapine (Lu 31-130), a monoaminergic atypical antipsychotic in Phase III testing for schizophrenia.

Otsuka is eligible to receive up to $1.8 billion, including $200 million up front and up to $1.6 billion in development, regulatory and sales milestones.

For the Otsuka products, the partners will evenly split net sales in Europe and Canada, while Lundbeck will receive 20% and 45% of net U.S. sales for aripiprazole depot and OPC-34712, respectively. Development and promotional costs will be shared in the same ratios.


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