Mr. David Pidduck reports
HISTORIC U.S. CANNABIS RESCHEDULING UNLOCKS POTENTIAL GROWTH OPPORTUNITIES FOR MEDIPHARM LABS, BACKED BY THE COMPANY'S SUITE OF LICENSES AND PROVEN U.S. CLINICAL TRIAL SUPPLY EXPERIENCE
Medipharm Labs Corp. has welcomed U.S. President Donald Trump's executive order to expedite the reclassification of cannabis under the U.S. Controlled Substances Act from Schedule 1 to Schedule 3.
This change recognizes the medical use of cannabis and reduces barriers to research. Medipharm Labs is well positioned to benefit from this milestone through its Food and Drug Administration site registration, drug establishment licence and proven experience supplying clinical trial materials to the United States.
"This reclassification order is a historic milestone that validates Medipharm's pharmaceutical approach and one that we anticipate will strengthen our ability to expand U.S. clinical trial partnerships," said David Pidduck, chief executive officer of Medipharm Labs. "This change could facilitate significant growth in clinical research, and Medipharm is uniquely prepared to support clinical trial partners and patients. We have already shipped product for U.S. trials, a capability that others may take years to achieve."
Rescheduling will accelerate cannabis clinical research
"This reclassification order will make it far easier to conduct marijuana-related medical research, allowing us to study benefits, potential dangers and future treatments," U.S. President Trump said in the Oval Office. "It's going to have a tremendously positive impact."
Reclassifying cannabis to Schedule 3 recognizes its medical use and will remove barriers that have long limited U.S. clinical trials. Researchers publish thousands of peer-reviewed cannabis studies annually, yet full clinical trials remain scarce due to Schedule 1 restrictions and lack of federally compliant cannabis. The FDA has also received more than 800 investigational new drug applications for cannabis-derived and cannabis-related products.
Rescheduling is expected to accelerate research by enabling access to standardized medical-grade cannabis from registered suppliers. For Medipharm, this could mean a pipeline of researchers ready to advance clinical trials and evaluate compliant active pharmaceutical ingredient suppliers. In addition to expanding research opportunities, reclassification may pave the way for future federally sanctioned medical access programs similar to those in Canada, Australia and Germany.
Medipharm's strategic advantage
Medipharm Labs has developed international licensing, U.S. clinical supply experience and global regulatory expertise over several years that position the company to serve the anticipated future expansion of United States-based research.
Proven record supplying U.S. clinical trials
Medipharm has supplied product for over 10 active clinical trials, including the U.S. National Institutes of Health-funded LiBBY study with the Keck School of Medicine of University of Southern California. To the company's knowledge, this was the first phase 2 clinical trial of its kind with API sourced from a Canadian licensed producer, with Medipharm navigating the complexities of the original Schedule 1 classification. Medipharm completed its first shipment to the U.S. in 2023 and has made additional shipments in subsequent years, leveraging its U.S. Food and Drug Administration site registration and drug enforcement administration import permits.
Medipharm is ready now to support new research partnerships
Medipharm believes that no other publicly listed cannabis-focused company in North America has the company's combination of experience, licensing (DEL, cannabis drug licence, natural health product licence, good manufacturing practices and European Union GMP certified operations) and an FDA-inspected facility. Medipharm was the first FDA-audited purpose-built commercial cannabis facility in Canada and one of only a handful globally.
These credentials reflect years of regulatory and quality work to achieve and enable Medipharm to immediately support new research initiatives in the U.S. and globally that require pharmaceutical-grade standards for purity and consistency.
Institutional pharma and biotech investment potential
Reclassifying cannabis to Schedule 3 may also allow institutional investors who were previously restricted by Schedule 1 trafficking clauses to consider research-oriented cannabis companies. This could result in increased interest in pharmaceutical cannabis companies, including Medipharm, as regulatory barriers evolve. There could also be renewed interest in research investments from pharmaceutical firms that previously avoided cannabis due to its high-risk classification.
About Medipharm Labs Corp.
Founded in 2015, Medipharm Labs specializes in the development and manufacture of purified, pharmaceutical-quality cannabis concentrates, active pharmaceutical ingredients and advanced derivative products utilizing a good-manufacturing-practice-certified facility with ISO-standard-built clean rooms. Medipharm Labs has invested in an expert, research-driven team, state-of-the-art technology, downstream purification methodologies and purpose-built facilities for delivery of pure, trusted and precision-dosed cannabis products for its customers. Medipharm Labs develops, formulates, processes, packages and distributes cannabis and advanced cannabinoid-based products to domestic and international medical markets.
In 2021, Medipharm Labs received a pharmaceutical drug establishment licence from Health Canada, becoming the only company in North America to hold a commercial-scale domestic good manufacturing licence for the extraction of multiple natural cannabinoids. The company carries out its operations in compliance with all applicable laws in the countries in which it operates.
In 2023, Medipharm acquired Vivo Cannabis Inc., which expanded Medipharm's reach to medical patients in Canada through the Canna Farms medical e-commerce platform, and in Australia and Germany through Beacon Medical Pty. and Beacon Medical GmbH. This acquisition also included Harvest Medical Clinics in Canada, which provides medical cannabis patients with physician consultations for medical cannabis education and prescriptions.
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