MMJ Bio Science has become the first company to obtain a Canadian license to produce medical cannabis, with the initial authorization covering products for multiple sclerosis and Huntington’s disease.
The Health Canada license allows the company to extract cannabinoids from plants that it grows to produce therapies that will be tested in U.S. Food and Drug Administration-approved studies.
MMJ is pursuing orphan drug status in the U.S. for MMJ-001, the company’s lead product, a cannabidiol (CBD) derivative and treatment candidate for MS patients. CBD and tetrahydrocanabinol (THC) are the most abundant cannabinoids in cannabis.
The company also wants to obtain orphan drug status for MMJ-102, its therapy for Huntington’s disease.
The FDA grants orphan drug status to medications intended for the safe and effective treatment, diagnosis or prevention of diseases that affect fewer than 200,000 people in the U.S. The status also applies to drugs that affect more than 200,000 patients but are not expected to recover the costs of their development and marketing.
Orphan designation gives companies seven-year marketing exclusivity, tax credits and federal grants for clinical trials, as well as waived FDA fees.
“The FDA’s granting of orphan designation for [MS] is a key step toward that goal,” Timothy Moynahan, chairman of MMJ International Holdings, the parent company of MMJ Bio Science, said in a press release.
“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.
In November 2017, MMJ International Holdings filed a U.S. patent application to cover MMJ Bio Science’s portfolio. It covered plants, plant extracts, plant variety rights, pharmaceutical formulations, patient monitoring technology, and drug delivery strategies.
The company plans a Phase 2 trial on MS with a part-cannabinoid and part-non-cannabinoid product formulation. It will be the company’s first study of a cannabis-based treatment for symptoms like pain and spasticity associated with MS. It is expected to start in 2018.
The company’s production facilities are licensed by Health Canada, inspected by the FDA and comply with what are called good manufacturing practices, ensuring quality standards.