Both the companies are negotiating an exclusive worldwide license that would result in Cannasat assuming product development and commercialisation rights to APL-130277 from Adagio in return for development milestones and royalties to Adagio, including common shares of Cannasat.
Reportedly, the license agreement includes an exclusive option period for the first 12 months which allows Cannasat to conduct further due diligence and proof-of-concept studies for APL-130277 prior to executing the full license. All aspects of the option and license agreements are subject to board approval.
APL-130277 is an oral formulation of an approved drug for parkinson’s patients designed to deliver clinical benefits over the current marketed treatment. The drug will treat patients with moderate to severe PD and address a significant unmet clinical need as expressed by clinicians and patients.
The drug is expected to undergo accelerated approval through 505(b) FDA regulatory pathway with the FDA and a similar pathway with other international regulatory agencies. This well developed regulatory path could result in a New Drug Approval application being submitted in late 2014 or early 2015.