MMJ International Holdings Is Betting on Medicine, Not Marijuana
Is Pharmaceutical Grade Cannabis Aiming for the Next Blockbuster?
Duane Boise, MMJ's CEO is banking on it. Backed by $10M+ in investment, vertically integrated cultivation and lab operations, and a patient-first mission, MMJ International Holdings is positioned to follow in the footsteps of Epidiolex and Marinol-cannabis derived drugs that now generate hundreds of millions annually.
WASHINGTON, D.C. / ACCESS Newswire / September 14, 2025 / In an industry dominated by recreational sales and wellness trends, MMJ International Holdings is pioneering a pharmaceutical-first approach to cannabinoid therapeutics. Led by CEO Duane Boise, the company is developing FDA-regulated, plant-derived drugs targeting rare neurological disorders and chronic conditions. With two Investigational New Drug (IND) applications filed with the FDA and Orphan Drug Designation for its Huntington's disease treatment, MMJ represents a major shift toward science driven cannabinoid medicine. Its strategy leverages the full therapeutic potential of cannabis within the FDA's gold-standard pharmaceutical framework-opening the door to billion-dollar markets while addressing critical unmet patient needs.
"MMJ International Holdings Is Betting on Medicine, Not Marijuana" Duane Boise CEO
The Pharmaceutical Approach to Cannabis Medicine
Beyond Dispensaries: Building Real Medicine
Unlike the fragmented dispensary model, MMJ is developing prescription-ready, pharmaceutical-grade softgel capsules. Its flagship products:
MMJ-001: for Multiple Sclerosis
MMJ-002: for Huntington's Disease (Orphan Designation granted)
These capsules are derived from proprietary cannabis cultivars, optimized to deliver balanced THC and CBD combinations. Each dose is standardized for consistency, potency, and bioavailability-qualities nearly impossible to achieve in retail cannabis.
"Our mission is to deliver cannabis as real medicine," says lead chemist Dr. Elio Mariani, who emphasizes preserving the entourage effect while meeting FDA requirements for dosing and safety.
Vertical Integration for Quality
Through its subsidiaries, MMJ maintains strict quality control from seed to softgel:
MMJ BioPharma Cultivation - grows proprietary cannabis strains optimized for pharmaceutical use.
MMJ BioPharma Labs - a DEA Schedule I licensed analytical lab manufacturing formulations under GMP standards.
This vertical model ensures consistency and regulatory compliance at every stage-critical factors for FDA approval and market acceptance.
Regulatory Strategy and Milestones: Navigating the FDA Pathway
MMJ has advanced through the challenging FDA drug development process:
Two INDs filed (MS & Huntington's Disease)
Orphan Drug Designation for Huntington's
Successful preclinical work with leading U.S. neurologists
Drug Candidate | Indication | Status | Key Advantage |
|---|---|---|---|
MMJ-002 | Huntington's Disease | Orphan Designation; Phase II pending | Natural THC/CBD; softgel delivery |
MMJ-001 | Multiple Sclerosis | IND submitted; Phase ll pending | Pharmaceutical-grade capsule |
Why Orphan Status Matters
The FDA's Orphan Drug Designation for Huntington's gives MMJ:
7 years of U.S. market exclusivity
Tax credits for clinical costs
Waived FDA fees (~$2.5M per filing)
Accelerated review pathways
This advantage positions MMJ to capture a first-mover monopoly in a devastating disease with no cure.
Market Potential and Opportunity: Following a Proven Trajectory
Cannabis-derived pharmaceuticals are proven blockbusters:
Marinol (dronabinol) - FDA-approved synthetic THC (~$250M annual sales)
Epidiolex (cannabidiol) - FDA-approved CBD drug, nearing $1B+ annual sales with a patient population of just ~100,000
"If Epidiolex can approach a billion dollars a year with such a small population, imagine the potential for MMJ's capsules treating Multiple Sclerosis, Huntington's, and eventually chronic pain," says Boise.
Expanding Beyond Orphan Diseases
Huntington's Disease - tens of thousands of patients, no effective treatments
Multiple Sclerosis - a multibillion-dollar global market
Chronic Pain - a $20B+ annual U.S. market, desperately seeking non-opioid alternatives
Given the opioid crisis-125M prescriptions in 2023 and 80,000 overdose deaths last year-safe cannabinoid-based pain therapies could transform care and capture significant market share.
Leadership and Motivation
Boise's mission is rooted in personal experience. His father served 40 years in law enforcement, and both parents battled Parkinson's disease. "That taught me the urgency of building legitimate, science driven treatments," he says.
To date, MMJ has invested over $10 million to bring this vision forward, navigating what Boise calls a "Kafkaesque trap" of U.S. cannabis regulations. Despite roadblocks, he has kept MMJ firmly aligned with FDA rules, distinguishing the company from recreational operators.
"If you're serious about medicine, you follow the science-not the hype," Boise notes.
Industry Landscape and Differentiation MMJ has carved out a unique position by:
Developing full-spectrum, natural cannabinoid formulations
Delivering via softgel capsules for reproducibility
Pursuing FDA drug approval, unlike supplement or state dispensary models
Compared with synthetic single-molecule THC (Marinol) or failed attempts like nabiximols, MMJ's natural, standardized softgels represent a new class of medicine with stronger clinical promise.
Outlook: From Quiet Player to Market Leader
Regulatory Tailwinds
DEA rescheduling to Schedule III could ease barriers
Trump administration drug development policy changes
Increasing FDA guidance supports botanical drug pathways
Growth Opportunities
Advancement of MMJ-002 into Phase II trials
Expansion of pipeline into pain and other neurological indications
International partnerships for global distribution
MMJ Redefining Cannabis Medicine
MMJ International Holdings is not chasing hype-it's building a pharmaceutical legacy. With orphan designation secured, INDs filed, and a pipeline designed for blockbuster potential, the company represents the quiet revolution in medical cannabis: transforming cannabinoids from uncertain dispensary products into standardized, FDA-approved medicines.
"MMJ didn't set out to sell marijuana," Boise emphasizes. "We set out to make real medicine-and that's what we've built."
MMJ is represented by attorney Megan Sheehan.
CONTACT:
Madison Hisey
MHisey@mmjih.com
203-231-85832
SOURCE: MMJ International Holdings
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/federal-legal-marijuana-mmjs-billion-dollar-trajectory-were-not-selli-1072832
