MMJ BioScience Obtains First Canadian License to Produce Medical Cannabis

MMJ BioScience Obtains First Canadian License to Produce Medical Cannabis

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.

 

4 comments

  1. Melinda says:

    I have multiple sclerosis. I was in wheel chair. Long story short. I’m walking now! Started smoking. Little by little I started moving my legs and now I’m walking, praise the Lord Jesus.

    • Julie Bassingthwaite says:

      Hi Julie B here, I have SPMS. Will this work for me? I have had ms for 20 yrs. EDSS 7. Does it matter how long you’ve had it or where you are in the disease??

  2. cynthia says:

    I had RRMS for over 20 years , and now it is SPMS. I started taking marijuana oil two months ago . The biggest plus for me is that I can sleep through the night……haven’t done that for many years. I mix it with juice and drink it an hour before bed.I used to be up 4 to 6 times every night because I was so uncomfortable ……I hated to go to bed before….now I sink into my bed and sleep so well!! It helps with spasms and cramps in my legs. My pharmacist recommended Sativex for MS , but it costs more , so I am trying the oil at the moment. In my opinion….it is wonderful.

  3. Agnes Weessies says:

    I would like to be kept in the loop for updates on the trails and their conclusions. My son was not diagnosed with MS until he he was literally days from dying. He takes 600 mg gabapentin 4 times a day. He has increased from 200 mg 3 times a day over the past 2 1/2 years. It calms some of the spasticity, allows him to at least sleep 4 hours at a time. As a mother I fear the day when this pain med has reached the limits he can take. He is half way there so it won’t be in the next couple of years. Cannabis/pot especially with the psychotropic component removed sounds like a God send. Please keep us/me informed.

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