TOKYO & STAMFORD, Conn.—Eisai Co. Ltd. and Purdue Pharma L.P. have announced a worldwide collaboration agreement between Purdue Pharma and Eisai Inc., Eisai Co.'s U.S. subsidiary. Under this agreement, the companies will develop and commercialize lemborexant, a dual orexin receptor antagonist being developed by Eisai for the treatment of insomnia. The drug candidate is currently entering Phase 3 clinical development.
Lemborexant is a dual orexin receptor antagonist that competitively binds to both subtypes of orexin receptors. Current evidence indicates that the orexin system promotes wakefulness, suggesting that orexin receptor antagonists such as lemborexant could have the potential to promote sleep.
“Eisai is excited about the significant and far-reaching potential of this compound as we commence Phase III clinical trials,” Dr. Lynn Kramer, president of the Neuroscience and General Medicine Product Creation Unit at Eisai, said in a press release. “We are looking forward to collaborating with Purdue Pharma, which brings deep expertise and proven successes in drug development and commercialization.”
Per the agreement, Eisai Inc. and Purdue Pharma will share the costs of global clinical studies for lemborexant. A joint steering committee will be formed to manage development of lemborexant and pursue appropriate marketing authorizations for the drug candidate worldwide. Should it receive approval, the two companies will co-promote lemborexant and share co-promotion costs and profits in the United States and other territories (to be agreed upon by both partners), which may include the European Union, China, Japan and Canada. Eisai will book sales in all co-promotion areas, and in select other countries, either Eisai or Purdue Pharma may solely commercialize lemborexant and pay the other party a royalty. Purdue Pharma will make an upfront payment to Eisai Inc., which also stands to receive other milestone payments dependent upon the achievement of regulatory approval and certain commercial milestones. Though the indication being pursued for lemborexant is insomnia, Eisai Inc. and Purdue Pharma can elect to develop it in other indications in the future.
The Phase 3 clinical development program for lemborexant will begin immediately. The global trial program will focus on evaluating the efficacy of the drug candidate on both objective and subjective measures of sleep, as well as the impact of lemborexant treatment of insomnia on daytime function. The program will also investigate lemborexant's safety and tolerability.
“This agreement reflects our strategy to diversify and grow our business through partnerships and business development,” commented Mark Timney, president and CEO of Purdue Pharma, in a statement about the deal. “We look forward to a productive relationship with Eisai and the prospects for growth this collaboration brings, as we seek to further expand our product portfolio with differentiated treatments.”
Some 30 percent of adults worldwide report one or more symptoms of insomnia, which include difficulty falling asleep, difficulty staying asleep, waking up too early and suffering from non-restorative or low-quality sleep. Insomnia is also known to affect daytime functioning as well, leading to impairments with thinking and concentration as well as altering mood.
SOURCE: Eisai Co. Ltd. press release