Eisai Inc will buy out Purdue LP’s rights to the worldwide collaboration for the development and commercialization of lemborexant, 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’s Disease.
Under the terms of the original agreement, which was established in August 2015, Eisai and Purdue shared the costs of lemborexant global clinical studies and the costs to prepare for commercialization. As part of the buy out arrangement, Eisai will provide a one-time payment to Purdue, and Purdue will no longer participate or fund the development and commercialization of lemborexant. Eisai will be solely responsible for conducting all future development and the commercialization activities globally.
“As a result of the ongoing diversification of our research product portfolio, Purdue’s business priorities have shifted since this collaboration was initiated,” says Craig Landau, MD, president and CEO, Purdue Pharma, in a release. “This mutual decision enables us to dedicate our resources to our oncology, non-opioid pain, and other CNS [central nervous system] programs. Purdue appreciates the opportunity to collaborate with Eisai and we wish them continued success with the advancement of lemborexant.”
Ivan Cheung, chairman and CEO, Eisai Inc, says, “We would like to thank Purdue for its contributions to lemborexant. Lemborexant’s unique profile was established by the results of two pivotal phase 3 clinical studies in patients with insomnia, including the first-ever head-to-head trial with zolpidem extended release with objectively assessed sleep parameters, and important safety studies, such as a next-morning driving study. We are extremely excited about the opportunity to bring lemborexant to the millions of people globally who suffer with insomnia and potentially other sleep-wake disorders.”
Lemborexant is a novel investigational small molecule compound, discovered and developed by Eisai in-house scientists. The US Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for lemborexant for review and set a Prescription Drug User Fee Act (PDUFA) date for December 27, 2019.