Eisai has signed a worldwide collaboration agreement with Purdue Pharma to develop and commercialise its clinical candidate lemborexant, which is being prepared to enter phase three clinical development for the treatment of insomnia.
Lemborexant, discovered by Eisai, is a dual orexin receptor antagonist that competitively binds to the two subtypes of orexin receptors.
The global trial programme has been designed to assess the efficacy of lemborexant on both objective and subjective measures of sleep.
The development programme will also assess the impact of treatment of insomnia on daytime function. During the clinical programme, safety and tolerability of the candidate will also be evaluated.
Purdue Pharma president and CEO Mark Timney said: “This agreement reflects our strategy to diversify and grow our business through partnerships and business development.”
As part of the deal, both firms will share the costs of global clinical studies related to lemborexant.
The firms are also planning to develop other indications in the future, while the potential indication for the product candidate is for the treatment of insomnia.
The companies will create a joint steering committee to manage development and pursue marketing authorisations for lemborexant across the globe.
Once the product receives approval, both firms will co-promote the product and share co-promotion costs and profits in the US and other territories such as the European Union, China, Japan and Canada.
Either Eisai or Purdue Pharma are expected to commercialise lemborexant in certain other countries and will pay a royalty to the other.
The deal will allow Eisai to secure an upfront payment from Purdue Pharma, in addition to certain other milestone payments based on achievement of regulatory approval and certain commercial milestones.