Charlotte’s Web, BAT subsidiary seek FDA approval for hemp drug

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Colorado-based CBD and hemp company Charlotte’s Web Holdings and a British American Tobacco subsidiary are teaming up to seek U.S. Food and Drug Administration approval for a drug containing hemp.

British American Tobacco (BAT) is investing $10 million toward the new joint venture between AJNA BioSciences PBC and Charlotte’s Web, according to a news release.

AJNA, a Littleton, Colorado-based company that makes botanical drugs for mental health and neurological disorders, was co-founded by Joel Stanley, a former CEO and board chair of Charlotte’s Web.

The $10 million investment gives BAT a 20% equity interest in the form of preferred units, and the London-based company can participate in future equity issuances to maintain its position.

Charlotte’s Web, based in Boulder, and AJNA each possess 40% of the joint venture’s voting common units.

The joint venture, to be co-led by representatives of Charlotte’s Web, AJNA and BAT, will file an Investigational New Drug (IND) application with the FDA and begin Phase 1 clinical development this year.

The drug will contain Charlotte’s Web hemp genetics, and AJNA will contribute its lab and regulatory services and clinical expertise.

To date, the FDA has approved only one cannabis-derived product, Epidiolex.

AJNA’s chief medical adviser, Orrin Devinsky, was a principal investigator for the development of Epidiolex.