Date: 2013-10-31
Type of information: Development agreement
Compound: up to five innovative psychiatric and neuroscience products including aripiprazole depot formulation, OPC-34712
Company: Lundbeck (Denmark) Otsuka Pharmaceutical (Japan)
Therapeutic area: CNS diseases
Type agreement: R&D
development
commercialisation
Action mechanism:
Disease:
Details: Lundbeck is granted co-development and co-commercialisation rights to aripiprazole depot formulation and OPC-34712 in North and Latin America, Europe, Australia and some other countries. With the comparable efficacy and safety profile to already marketed aripiprazole formulations, aripiprazole depot formulation has been developed to reduce the chance of reoccurrence of symptoms for the 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 is expected soon to be submitted to the FDA, and Lundbeck expects that the Marketing Authorisation Application (MAA) is to be submitted in Europe during 2013.* On October 31, 2013, Lundbeck and Otsuka Pharmaceutical have announced that their existing alliance now also includes the development and commercialization of nalmefene (sold under the brand name Selincro® in Europe) in Japan. Earlier this year, nalmefene was approved by the European Medicines Agency as the first treatment for the reduction of alcohol consumption.Under the terms of the agreement, Lundbeck will receive from Otsuka an initial payment of €50 million (approximately DKK 375 million) upon signing. Lundbeck will finance the development costs and has an option to co-promote the product in Japan. Also, Lundbeck will produce the tablets for the Japanese market and is entitled to sales royalties and sales milestones. If all milestones in the agreement are achieved, the total value of the agreement to Lundbeck would be approximately €100 million (approximately DKK 745 million), plus royalties related to the revenue in Japan. Additional specific financial terms of the agreement remain undisclosed. Lundbeck and Otsuka will jointly finalize the clinical program for nalmefene in Japan. It is expected that the first clinical phase III study will be initiated during 2014. In November 2011 Lundbeck and Otsuka established a global collaboration to bring to patients therapies for better mental health. This collaboration is now strengthened with the inclusion of nalmefene in Japan.
Lundbeck has an option to co-promote the product in Japan.
* On November 11, 2011, Lundbeck and Otsuka have announced a development and commercialisation agreement for up to five products in the psychiatry field, including aripiprazole depot formulation and OPC-34712 from Otsuka and up to three highly innovative earlier stage projects from Lundbeck. The long-term alliance including the near-term projects from Otsuka and the earlier stage psychiatric disorder portfolio from Lundbeck enhances both companies’ portfolios of new medical offerings covering all aspects of severity in the treatment of patients suffering from psychotic, mood and behavioural disorders. In addition, this collaboration agreement will accelerate the development of Lundbeck’s most advanced schizophrenia projects.
OPC-34712 is a novel investigational psychotherapeutic compound developed to provide improved efficacy and tolerability (e.g., less akathisia, restlessness and/or insomnia). The compound has broad activity across multiple monoamine systems and exhibits reduced partial agonist activity at D2 dopamine receptors and enhanced affinity for specific serotonin receptors. OPC-34712 has entered into clinical phase III trial for schizophrenia and adjunctive treatment of major depressive disorder (MDD).
Under the terms of the agreement, Otsuka has an option to enter into co-development and co-commercialisation of up to three early stage compounds in Lundbeck’s R&D pipeline in certain geographical regions. The three compounds to be included in this collaboration are under discussion between Lundbeck and Otsuka.
Financial terms: The alliance is a sales and cost share agreement. Under the terms of the agreement, Lundbeck will make an upfront payment upon signing of $ 200 million (approximately DKK 1.1 billion - € 145,45 million). Otsuka will in total receive approximately $ 1.4 billion (approximately DKK 7.6 billion - € 1 billion)) from Lundbeck as upfront payment and development and regulatory milestone payments. Including sales milestones Lundbeck will pay up to approximately $ 1.8 billion (approximately DKK 9.7 billion - € 1.3 billion) to Otsuka. Both companies will share the sales as well as development and commercialisation costs based on the agreement.
For aripiprazole depot formulation, Lundbeck will obtain 50% of net sales in Europe (EU5 and the 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 at a price agreed upon as a percentage of sales.
For OPC-34712, Lundbeck will obtain 50% of net sales in Europe (EU5 and the Nordic countries) and Canada and 45% of net sales in the US 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, Turkey and Egypt. For the remaining markets in the Lundbeck territories, Lundbeck will market the compound, and Otsuka will supply the bulk at a price agreed upon as a percentage of sales. For the development costs of OPC-34712, Otsuka will be responsible up to a certain amount and equally share the costs with Lundbeck afterwards.
In co-commercialisation countries, the parties will share sales efforts and costs in accordance with the territory split. In the US, Canada, EU5 and the Nordic countries, Otsuka will book all sales. In the rest of Europe and the world, excluding many of the Asian countries, Turkey and Egypt, Lundbeck will book all sales and take full responsibility for commercialisation. Otsuka will retain the rights to participate in the co-development and co-marketing when it establishes a sales organisation in Lundbeck’s territory.
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