• by Steve Ellwanger , April 7, 2023

Hemp-derived CBD marketer Charlotte’s Web is teaming with British American Tobacco in an attempt to develop a “novel botanical drug” to target an undisclosed neurological condition.

British American is paying $10 million for a 20% equity interest in the joint venture—with Charlotte’s Web and botanical drug-development company AJNA BioSciences PBC each holding 40%.

The drug will be developed using “certain proprietary hemp genetics” owned by Charlotte’s Web.

The joint venture said yesterday that it plans to file an Investigational New Drug application with the U.S. Food and Drug Administration and commence phase 1 clinical development this year.

Leading the joint venture will be Dr. Orrin Devinsky, who helped to develop the first and only FDA-approved drug containing marijuana-derived CBD—branded Epidiolex—in 2018.

“I believe the properties of cannabis and hemp are well suited for the FDA's new Botanical Drug Development pathway,” Devinsky said in a news release.

British American said the joint venture represents “another step for BAT in our exploration beyond tobacco and nicotine.”

AJNA is partially owned and was co-founded by its president, Joel Stanley, the former CEO and board chairman of Charlotte's Web, together with other founding members of CW.

Epidiolex was approved in for the treatment of seizure disorders Dravet and Lennox-Gastaut syndromes, which are rare and severe forms of pediatric epilepsy.

The inclusion of CBD in Epidiolex is the reason why the federal government considers CBD to be a drug.

As such, in the absence of long-awaited guidelines from the FDA, CBD cannot be legally included in food or beverages.