IntelGenx (TSX-V:IGX; OTCQX:IGXT) and Tetra Bio-Pharma (CSE:TBP; OTC: GRPOF) announced the signing of a binding term sheet for the development and commercialization of a drug product containing dronabinol.
Under the binding term sheet, Tetra will have exclusive rights to sell the product in North America, with a right of first negotiation for outside the U.S. and Canada.
Under the accord, Tetra will make a non-refundable exclusive negotiation payment to IntelGenx, an upfront payment along with set milestone payments based on completion of an efficacy study, approvals from FDA and Health Canada and launching of the product.
IntelGenx will be responsible for the research and development of the product, including clinical studies and will develop the product as an oral mucoadhesive tablet based on its proprietary AdVersa controlled-release technology.
Tetra will be responsible for funding product development, and will control all regulatory approvals, including the application and any other marketing authorizations. Tetra will also be responsible for all aspects of commercializing the drug product.
“We are pleased to partner with Tetra Bio-Pharma to enter the lucrative cannabis market,” IntelGenx president and CEO, Dr. Horst Zerbe, said in a statement. “We will work with Tetra to bring this much needed THC product to North American patients suffering from anorexia and cancer chemotherapy-related pain.”
PhytoPain Pharma, a subsidiary of Tetra, will be submitting a request for a Type B pre-IND meeting with the Division of Anesthesia, Analgesia, and Addiction Products, Center for Drug Evaluation and Research, and FDA to discuss marketing requirements for Dronabinol AdVersa Mucoadhesive tablet as an analgesic for the management of breakthrough cancer pain.
The company will also be meeting with the Therapeutic Product Directorate, Health Canada, to discuss clinical development and marketing requirements.