WOODCLIFF LAKE, N.J. and STAMFORD, Conn., April 30, 2019 /PRNewswire/ -- Eisai Inc. and Purdue Pharma L.P. today announced that Eisai will buy out Purdue'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," said Craig Landau, MD, president and CEO, Purdue Pharma. "This mutual decision enables us to dedicate our resources to our oncology, non-opioid pain, and other CNS programs. Purdue appreciates the opportunity to collaborate with Eisai and we wish them continued success with the advancement of lemborexant."
"We would like to thank Purdue for its contributions to lemborexant," said Ivan Cheung, chairman and CEO, Eisai Inc. "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 U.S. 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.
About Eisai Inc.
At Eisai Inc., human health care (hhc) is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo- based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to discover and develop innovative therapies to help address unmet medical needs.
Eisai is a fully integrated pharmaceutical business that operates in two global business groups: oncology and neurology (dementia-related diseases and neurodegenerative diseases). Each group functions as an end-to-end global business with discovery, development, and marketing capabilities. Our U.S. headquarters, commercial and clinical development organizations are located in New Jersey; our discovery labs are in Massachusetts and Pennsylvania; and our global demand chain organization resides in Maryland and North Carolina. To learn more about Eisai Inc., please visit us at www.eisai.com/US.
About Purdue Pharma L.P.
Purdue Pharma and its subsidiaries develop and provide prescription medicines that meet the evolving needs of healthcare professionals, patients, and caregivers. We were founded by physicians and are currently led by a physician. Beyond our efforts to provide quality medications, Purdue Pharma is committed to supporting national, regional and local collaborations to drive innovations in patient care while also continuing our efforts to address the opioid addiction crisis.
Purdue established Imbrium Therapeutics L.P. to further advance its emerging portfolio and develop its pipeline in the areas of CNS, non-opioid pain medicines, and select oncology through internal research, strategic collaborations and partnerships. Purdue's subsidiaries also include Adlon Therapeutics L.P., focused on treatment for Attention-Deficit/Hyperactivity Disorder (ADHD) and related disorders, and Greenfield Bioventures L.P., an investment vehicle focused on value-inflection in early stages of clinical development. For more information, visit www.purduepharma.com.
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SOURCE Eisai Inc.
Type Press Release
Date Released April 30, 2019