Eisai buys out Purdue's rights on lemborexant

Japanese drug major Eisai (TYO: 4523) says that its US subsidiary has bought out Purdue Pharma's rights in the worldwide collaboration for the development and commercialization of investigational dual orexin receptor antagonist lemborexant.

Financial terms of the transaction were not disclosed and, with Japanese markets closed due to the annual Golden week holiday, there was no impact of the news on Eisai’s share price.

Lemborexant is an investigational sleep-wake regulation agent being studied for the treatment of multiple sleep-wake disorders, including insomnia and irregular sleep-wake rhythm disorder (ISWRD) in patients with Alzheimer disease. Eisai group will solely conduct the development and the commercialization of lemborexant globally.

The US Food and Drug Administration accepted the New Drug Application (NDA) for lemborexant for use in the treatment of insomnia disorders for review in March 2019 and set a Prescription Drug User Fee Act (PDUFA) date for December 27, 2019. For Japan, a marketing authorization application for lemborexant for use in the treatment of insomnia disorder has been submitted to the Pharmaceuticals and Medical Devices Agency (PMDA) in March 2019 and is currently under review. Furthermore, a Phase II clinical study of lemborexant for ISWRD in patients with Alzheimer's disease is ongoing.