Charlotte’s Web and BAT Subsidiary Partner for Hemp Drug FDA Approval 

Charlotte’s Web Holdings, a Colorado-based CBD and hemp company, and a subsidiary of British American Tobacco (BAT) have joined forces to develop a hemp-containing drug with U.S. Food and Drug Administration (FDA) approval. BAT is investing $10 million in the joint venture between AJNA BioSciences PBC and Charlotte’s Web. AJNA, a Littleton, Colorado-based botanical drug maker for mental health and neurological disorders, was co-founded by Joel Stanley, the former CEO and board chair of the company. BAT’s investment gives them a 20% equity interest in the form of preferred units, and they can participate in future equity issuances to maintain their position. Both enterprises will hold 40% of the joint venture’s voting common units each. The co-led joint venture aims to file an Investigational New Drug (IND) application with the FDA and begin Phase 1 clinical development this year. The drug will include 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. Orrin Devinsky, AJNA’s chief medical adviser, was a principal investigator for the development of Epidiolex.

In summary, Charlotte’s Web Holdings, a CBD and hemp company based in Colorado, and a subsidiary of British American Tobacco (BAT) have partnered to develop a hemp-containing drug that has approval from the U.S. Food and Drug Administration (FDA). BAT is investing $10 million in the joint venture between AJNA BioSciences PBC and Charlotte’s Web. AJNA is a company based in Littleton, Colorado, that develops botanical drugs for mental health and neurological disorders, co-founded by Joel Stanley, the former CEO and board chair of the company. BAT’s investment gives them a 20% equity interest in the form of preferred units, and they can participate in future equity issuances to maintain their position. Charlotte’s Web and AJNA will hold 40% of the joint venture’s voting common units each. The joint venture will be co-led by representatives from Charlotte’s Web, AJNA, and BAT. The goal is to file an Investigational New Drug (IND) application with the FDA and start Phase 1 clinical development this year. The drug will use Charlotte’s Web hemp genetics, and AJNA will contribute its lab and regulatory services and clinical expertise. The FDA has only approved one cannabis-derived product, Epidiolex, to date. Orrin Devinsky, AJNA’s chief medical adviser, was a principal investigator for the development of Epidiolex.