The license will enable MMJ to extract active pharmaceutical ingredients from the cannabis plant to manufacture gelcap medications and supply pharmaceutical-grade medicines for its studies which have been approved by the U.S. Food and Drug Administration.
The license includes MMJ 001, a cannabidiol (CBD) derivative for MS, and MMJ-002, a CBD derivative for Huntington’s.
”MMJ is in the process of securing orphan [drug] designation for our lead product, MMJ 001, a cannabidiol (CBD) derivative, for multiple sclerosis in the U.S.,” Tim Moynahan, MMJ BioScience’s chairman, said in a press release.
“MMJ BioScience also plans to repeat that accomplishment for MMJ-102 for Huntington’s disease,” he said.
“The FDA’s granting of orphan designation for multiple sclerosis is a key step toward that goal. These are debilitating diseases that need new and more innovative treatments, and we look forward to working with the FDA to begin clinical trials to fully explore the potential of cannabis medicines,” Moynahan added.
The FDA’s orphan drug status is granted to therapies and biologics targeting rare diseases, or those affecting fewer than 200,000 people in the United States. Benefits include seven-year marketing exclusivity if approved, tax credits for clinical trials, federal grants, and FDA guidance.
The announcement follows a MMJ’s January 2018 filing of a U.S. patent invention for its cannabis-based products for people with cannabinoid-responsive rare diseases.
The patent protects an alternative method to administrate the cannabinoid-based products without the psychoactive side-effects commonly associated with the plant and without the dangers associated with smoking.
MMJ BioScience is preparing to initiate a Phase 2 clinical trial this year in MMJ-001. The company expects to bring cannabinoid-based prescription medicines to market by 2020 to provide new therapeutic alternatives to patients with severe conditions even in states where cannabis products have yet to be legalized.
If Health Canada and the FDA approve MMJ BioScience’s products, it may have a major impact on the regulatory and legal issues the cannabis industry has been involved with in recent years.