PHARMACEUTICAL company Indivior is expanding into medicines for cannabis-related disorders.
The London-listed company has agreed an upfront $30m rights deal with French biotechnology firm Aelis Farma to bring a cannabis use disorder therapy ‘into the clinic’.
The move marks a first for Indivior as it looks to diversify beyond its core opioid addiction treatments and expand into under treated cannabis-related disorders.
The company manufactures and markets medicines for the treatment of opioid-use disorders with a global portfolio in more than 40 countries.
Under the terms of the $30m deal, US headquartered Indivior will have an exclusive global option on AEF0117, Bordeaux-based Aelis’ Signalling Specific inhibitor (SSI) designed to stall the cannabinoid type 1 receptor, following a successful Phase 2a study on subjects with cannabis use disorder (CUD).
$£30m Upfront – $100m To Follow
The option gives Indivior the right to assume all development and commercialisation activities for AEF0117 upon successful completion of a planned Phase 2b trial by Aelis in return for an additional $100m and a series of potential milestone payments and sales-based royalties.
Indivior CEO Mark Crossley, said: “Our heritage and focus at Indivior is helping address unmet needs for people struggling with substance use disorders. Increasing prevalence of cannabis from the growing movement to legalise medical and recreational marijuana use is leading to greater concern for the potential of adverse outcomes, including elevated addiction risk.
“Cannabis is the most commonly used substance of abuse in the US after alcohol and tobacco, however, we have no FDA-approved medications for cannabis-related disorders, which are complex and concerning.
“AEF0117 is the most advanced new chemical entity under investigation in the clinic and potentially represents a unique opportunity to address a growing unmet public health need.”
Completed Phase 1 clinical studies for AEF0117 have suggested good safety and tolerability and a recently-completed 29-patient Phase 2a study in subjects with CUD demonstrated positive effectiveness signals.
Under the agreement, Aelis will fund and manage a multi-centre Phase 2b proof of concept study of AEF0117 evaluating the efficacy of the compound as a treatment of CUD. It will be coordinated by Professor Frances Levin at Columbia University in the US.
Assuming successful completion of the Phase 2b study, the exclusive option gives Indivior the right to assume full control of clinical development and commercialisation of AEF0117 in return for the $100m payment to Aelis.
Phase 3 studies and commercialisation would then be at Indivior’s direction and expense.
Aelis would also be entitled to certain other development and sales milestones, including payments linked to US NDA filing acceptance and NDA approval, as well as royalties in the mid-teen percentage range on global net sales.
AEF0117 is a new chemical entity with a US composition of matter patent expiring in 2033 and a method of use patent extending to 2039.