ST. PETERSBURG, FL / ACCESSWIRE / August 17, 2020 / MMJ Biopharma Cultivation (MMJBC) has applied for the covetable Drug Enforcement Agency (DEA) Federal Marijuana Growers' license. The cannabis cultivation company negotiated an agreement with leading pharmaceutical company MMJ International Holdings (MMJIH) to supply pharmaceutical-grade extracts for its orphan drug for Huntington's Disease and Multiple Sclerosis. MMJ Biopharma is growing cannabis in collaboration with a Native American tribe on sovereign land.
The Federal Government recognizes Native American tribes as sovereign nations, with the inherent right to self-govern. Therefore, working together with the tribe delivers game-changing innovation, providing increased profits, operating efficiencies, and flexibility. This leading competitive edge results in an advantageous, never-ending, disruptive business model.
MMJBC's tribal collaboration creates employment opportunities that exclude potential competition from any other existing cultivators. Economic development for Native American tribes includes leveraging every unique advantage permitted by tribal sovereignty to create mutually-beneficial, increased revenue streams. For example, cultivating cannabis is a diversified source of income that moves away from operating casinos. MMJIH's pre-existing consumer base comprised of Multiple Sclerosis and Huntington's disease patients and their caregivers significantly reduces any capital requirements or risk for the tribe.
Simultaneously, MMJ International Holdings achieved multiple milestones in developing its tetrahydrocannabinol (THC) and cannabidiol (CBD)-based medicine. MMJIH continues to follow U.S. Food and Drug Administration (FDA) guidelines to develop its gel cap medicine.
Most recently, MMJ International Holdings received a DEA permit to import its cannabis proprietary extracts into the United States for potential therapies for Huntington's Disease and Multiple Sclerosis.
Two of MMJ's lead therapeutic candidates, MMJ-001 and MMJ-002, are liquid formulations containing highly purified THC, CBD, and other active ingredients. MMJ-001 is in development to treat spasticity (abnormal muscle stiffness) in people with multiple sclerosis. MMJ-002 is evolving to treat Huntington' s-associated chorea (involuntary jerking or writhing movements). FDA granted MMJ-002 orphan drug designation in early 2019, to advance the therapy's development.
FDA published draft guidance on marijuana and CBD research that recently cleared a White House Office of Management and Budget.
"Our experienced team has worked within the FDA guidelines to obtain significant approval from the Center for Drug Evaluation and Research. MMJ now can proceed to develop our cannabis-derived, whole-plant, natural extracts for our oral gel cap medication's clinical trials in the United States," said Duane Boise, CEO of MMJ Biopharma.
Dr. Elio Mariani, the Company's Executive VP in charge of drug development concurs. "We firmly believe that our MMJ oral gel cap medication, containing the marijuana plant's unique pharmacological properties, will be FDA-approved as a safe and effective drug," he said.
Tim Moynahan, MMJ International Holdings' Chairman, stated, "Because cannabis is a federally-controlled substance in the U.S., there are numerous, complicated legal hurdles that we have cleared in order to proceed with our scheduled clinical trials. Our experienced team has worked within the federal guidelines to accomplish these significant goals.
Furthermore, MMJIH surpassing these milestones required the cooperation of many government agencies, including FDA, DEA, U.S. Customs and Border Protection (CBP), Health Canada, and the Center for Drug Evaluation and Research (CDER) in facilitating the company's mission.
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Mr. Michael Sharpe
SOURCE: MMJ BioPharma Cultivation