The medical sciences research company, MMJ International Holdings, based in the United States and Jamaica, has reached an agreement with Thermo Fisher Scientific to manufacture its oral drug product for treating multiple sclerosis (MS) and Huntington’s disease (HD).
MMJ International Holdings, under the terms of the agreement, will develop the active pharmaceutical ingredient (API) for drug product MMJ 001 as a liquid-filled gel capsule.
MMJ-001 is derived from the marijuana plant containing tetrahydrocannabinol (THC) and cannabidiol (CBD) as a natural whole plant extract.
“As MMJ International Holdings continues to advance to its clinical trials, ThermoFisher Scientific will be supporting MMJ with the FDA, DEA required development API for MMJ’s specialised liquid encapsulation solutions,” said Elio Mariani, executive vice-president of research & development at MMJ.
“Patients will be expected to benefit from cGMP (current Good Manufacturing Practice)-quality therapies in an accessible and efficient format.”
This manufacturing agreement enables the development and future commercialisation of MMJ’s novel THC- and CBD cannabinoid-based medicine for therapeutic applications across a broad range of diseases once FDA approved. MMJ International Holdings has been at the forefront of THC, CBD based drug research for the treatment of serious diseases, including MS and HD.
“We firmly believe that our MMJ natural whole plant derived molecules with a unique combination of pharmacological properties will be FDA approved as a safe and effective prescription drug that can be of great benefit in treating patients with MS and HD diseases,” said Duane Boise, CEO of MMJ International Holdings. “This agreement with Thermo Fisher Scientific will help us succeed with our company mission to service the unmet needs of patients suffering from these chronic diseases.”
When contacted by the Jamaica Observer for an estimate of how long the development and manufacturing process will take before the drug reaches the market, Boise explained that there is still a significant amount of testing that they will be required to do.
“The FDA is requiring us to perform stability testing of the active ingredients in the gel caps before we can give the medicine to patients in the clinical trials,” he revealed.
“The FDA wants us to be sure the actives are not changing and what the expected shelf life of the medicine will be. Pending any further FDA test we anticipate 18-24 months before we can commercialise the drug. During that time we will be conducting our phase 2 clinical trial.”
Boise was also asked how long before the drug could be made available in Jamaica.
“The drug could be available sooner in Jamaica if we meet the regulatory requirements of the Jamaica Ministry of Health and we are moving forward with that initiative,” he replied.
The joint development programme between MMJ International Holdings and ThermoFisher Scientific will ensure the develop-ability of MMJ’s molecules. The combined team of pharmaceutical development experts will apply collaborative, scalable and science-based approaches to proactively solve a wide range of formulation development challenges from dosing and bioavailability to stability of MMJ’s complex formulations.
Sunday Finance inquired if there were any developments within the operations of MMJ International Holdings involving Jamaican participation at this time.
“We are working in collaboration with The University of the West Indies on development of clinical trials and Northern Caribbean University on other developments,” Boise revealed, adding that he was not able to give too many details at this time.
“What I can say now is that we have definitive agreements signed and we have designed protocols for clinical trials.”