Date: 2013-03-26

Type of information: Licensing agreement

Compound: Lu AE58054 (idalopirdine)

Company: Lundbeck (Denmark) Otsuka Pharmaceutical (Japan)

Therapeutic area: Neurodegenerative diseases

Type agreement:




Action mechanism:

5-HT6-receptor antagonist. Lu AE58054 is a selective 5-HT6-receptor antagonist. The 5-HT6-receptor is primarily found in areas of the brain involved in cognition. A number of early trials have demonstrated that a 5-HT6-receptor antagonist could offer potential benefits in the treatment of disorders such as Alzheimer\'s disease and in November 2009 Lundbeck initiated the above described 24 week clinical phase II trial with Lu AE58054 as augmentation therapy in Alzheimer\'s disease.

Disease: Alzheimer's disease


Lundbeck and Otsuka Pharmaceutical have announced a license and development agreement for Lu AE58054, a selective 5HT6 receptor antagonist currently in development for the treatment of Alzheimer’s disease. Under the terms of the agreement, Lundbeck will grant Otsuka co-development and co-commercialization rights to Lu AE58054 in the U.S., Canada, East Asia including Japan, major European countries and Nordic countries. The pivotal clinical program with Lu AE58054 is planned to be initiated later in 2013. The global program will consist of several studies and include more than 2,500 patients. The first phase III study will enroll patients with mild-to-moderate Alzheimer’s disease. Lu AE58054 will be tested as adjunct treatment to donepezil. Subsequent studies are expected to be initiated towards the end of 2013.
In May 2012, it was announced that Lu AE58054 had met its primary endpoint in a fixed dose, randomized, placebo-controlled, 24-week clinical study in 278 patients. The study was conducted in patients suffering from moderate Alzheimer\'s disease, with Lu AE58054 administered as an add-on to donepezil, a commonly used acetylcholinesterase inhibitor. The clinical data from the phase II study is planned to be presented at the annual Alzheimer’s Association International Conference (AAIC) in Boston on 13-18 July 2013. 
In November 2011, Lundbeck and Otsuka have concluded 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. Within the two companies’ global agreement Lu AE58054 is the first of the projects that will ultimately involve co-development and co-promotion of three Lundbeck drug candidates

Financial terms:

Under the terms of the agreement, Lundbeck will receive from Otsuka an initial payment of $150 million (approximately DKK 855 million - € 116.6 million) upon signing. Both companies will share the sales, development, and commercialization costs based on the agreement. Lundbeck is also entitled to up to $ 675 million (approximately DKK 3.9 billion - € 524.9 million) in regulatory and sales milestones. Additional specific financial terms of the agreement remain undisclosed.

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