There’s no one else in the pipeline, but Indivior is making a bet that Aelis Farma has what it takes to bring a cannabis use disorder therapy into the clinic with a $30 million upfront rights deal.
Aelis, a clinical-stage French biotech focused on brain disorders, will receive an upfront payment of $30 million from addiction-focused pharmaceutical company Indivior in a joint effort on cannabis use disorders such as cannabis-induced psychosis.
Indivior is betting on the growth industry of cannabis as it looks to cash in on the seven-year development of Aelis’ lead candidate, AEF0117. The drug is a synthetic signaling specific inhibitor that inhibits the cannabinoid type 1 receptor. Early and mid-stage testing of AEF0117 has suggested it is safe and tolerable and could be effective against the disorder, the companies said.
If Aelis successfully completes a planned phase 2b study, coordinated at Columbia University, the biotech could get a nice paycheck from Indivior for $100 million plus potential milestone payments and royalties.
In exchange, Indivior secures an exclusive global option for AEF0117, including global rights on a patent covering the drug, as well as related compounds. Aelis’ second compound, AEF0217, is a treatment for cognitive disorders at the clinical stage. Additional compounds are being explored using Aelis’ CB1-targeted drug screening platform.
Indivior will also handle the direction and expense of phase 3 studies and commercialization. Royalties for Aelis could be in the mid-teen percentage range on global net sales.
“We are very excited to collaborate with Indivior, whose experience developing approved treatments for addiction and serious mental illnesses will accelerate the development of our new class of therapeutics and the unique approach to cannabis use disorders they provide,” said Pier Vincenzo Piazza, Ph.D., CEO and co-founder of Aelis, in a statement.
Virginia-based Indivior has a line of approved drugs to address the opioid crisis, including Sublocade and Suboxone. Indivior also markets Perseris, an approved drug for the treatment of schizophrenia in adults.
Sublocade sales in the first quarter of 2021 grew 38% year over year to $40 million. Perseris revenue remained flat in the same period at $3 million. Suboxone, a prescribed treatment for opioid dependence, has spelled trouble for Indivior, which had to pay $103 million last November under a resolution with U.S. federal agencies, with more annual payments to come until December 2027.
Now, Indivior is hoping to jump into the fast-growing cannabis landscape. More than 48 million people consumed marijuana in the country in 2019 and 4.8 million people had a cannabis use disorder during that period, the companies said, citing data from the Substance Abuse and Mental Health Services Administration.
There are no FDA-approved treatments for cannabis use disorders, according to the National Institute on Drug Abuse. Common pharmaceutical treatments include using medications that can aid with sleep deprivation, which is a common symptom of marijuana withdrawal.
“Cannabis is the most commonly used substance of abuse in the U.S. after alcohol and tobacco; however, we have no FDA-approved medications for cannabis-related disorders, which are complex and concerning,” said Indivior CEO Mark Crossley in a statement. “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.”