Two Colorado-based hemp companies and one tobacco company are joining forces to pursue FDA-approval for a new botanical drug.
In early April 2023, three companies announced their joint efforts to pursue approval from the Food and Drug Administration (FDA) for a new botanical drug to target a neurological condition (1). The two Colorado-based hemp companies are Charlotte’s Web, a cannabidiol (CBD) and hemp extract wellness products company, along with AJNA BioSciences PBC, a botanical drug development company focused on natural pharmaceuticals that address mental health and neurological disorders (1). The third company, British American Tobacco (BAT) is an international company that manufactures and sells nicotine products (1).
“The JV [joint venture] was established to pursue FDA-approval for a novel botanical drug to target a neurological condition identified by the JV leadership team, which will be comprised of CW, AJNA, and BAT representatives…The JV plans to engage with the FDA to file an Investigational New Drug (IND) application and commence Phase I clinical development in 2023,” stated the press release (1). Charlotte’s Web and AJNA each hold 40% in the venture, the drug will contain hemp genetics from Charlotte’s Web, and AJNA will provide laboratory, regulatory services, and clinical expertise. (2).
Leading the clinical and regulatory strategy is AJNA's Chief Medical Advisor, Orrin Devinsky, MD, PhD. Dr. Devinsky is the Director of New York University (NYU) Langone's Comprehensive Epilepsy Center and was a principal investigator for the development of Epidiolex (1). "As one of the first clinicians to research novel cannabinoids, I am very excited to work on this project. I believe the properties of cannabis and hemp are well suited for the FDA's new Botanical Drug Development pathway,” Dr. Devinsky said (1).
"This joint venture is a capital efficient way for Charlotte's Web to unlock the value of its intellectual property to advance development of effective botanical alternatives to current neurological pharmaceuticals," said Jacques Tortoroli, CEO of Charlotte's Web (1).
"Our investment in the Joint Venture reinforces our commitment to Charlotte's Web and represents another step for BAT in our exploration beyond tobacco and nicotine,” said James Barrett, Commercial Director of Wellbeing and Stimulation at BAT (1). BAT had also invested in Charlotte’s Web in November 2022 (3).