Subsidiary of British American Tobacco, Charlotte's Web, Seeks FDA Approval for New Drug

One of the top CBD product manufacturers is teaming up to a subsidiary of the largest tobacco company in the world to obtain regulatory approval for a new herbal drug. Charlotte’s Web Holdings is a market leader for full-spectrum hemp extract wellness items. On April 6, the companies announced that they would form a joint venture with AJNA BioSciences PBC (or “AJNA”) to seek FDA approval for a new botanical drug. The announcement stated that the joint venture will engage with the FDA to file an Investigational New Drug (“IND”) application and begin Phase I clinical development in 2023. “The joint venture plans to engage the FDA to file an Investigational New Drug (“IND”) request and begin Phase I clinical development in 2023,” Jacques Tortoroli (CEO of Charlotte’s Web), said Thursday. Orrin Devinsky (M.D.), Ph.D. will lead the joint venture. He is a neurologist and researcher and will oversee its regulatory and clinical strategy. “I am excited to be working on this project as I was one of the first to conduct research on novel cannabinoids. Devinsky stated that the FDA’s new Botanical Drug Development Pathway is well-suited for cannabis and hemp. The company bought a minority stake in Sanity Group GmbH, a Berlin-based marijuana startup. This was last year’s “ongoing work to examine numerous areas beyond nicotine, positioning BAT to future portfolio growth across various categories and geographies.” Our goal is to harness the full potential of cannabis and to explore and harness its cannabinoids. With the new capital, we will now be able to accelerate the medical and consumer business units while preparing for the legalization of cannabis in Germany. Hansel stated that BAT continues to transform their business through strategic investments in new sciences, technology, and consumer businesses as part of its mission to build A Better Tomorrow.