MediPharm announces first delivery of pharmaceutical cannabis product for NIH funded clinical trial, following import permit from the US Drug Enforcement Agency (DEA) and Health Canada export permit.
MediPharm has provided a full response to the US Food and Drug Administration (FDA) in relation to the initial pre-approval site inspection of its Barrie facility regarding a new Drug Master File (DMF) being referenced in a recent Abbreviated New Drug Application (ANDA).
This is the first US FDA Audit of a purpose-built commercial cannabis facility in Canada.
The US delivery and FDA inspection represent major milestones in MediPharm Labs being a pharmaceutical cannabis supplier of choice to the global pharmaceutical industry.
TORONTO, Aug. 1, 2023 /PRNewswire/ - MediPharm Labs Corp. (TSX: LABS) (OTCQB: MEDIF) (FSE: MLZ) ("MediPharm", "MediPharm Labs" or the "Company") a pharmaceutical company specialized in precision-based cannabinoids, is pleased to announce it has made its first delivery to the United States, and has completed the US FDA drug API manufacturer inspection at the Company's Barrie, Ontario facility.
First Delivery of Pharmaceutical Cannabis Product to the US
On July 28, 2023, MediPharm completed a commercial shipment of cannabis clinical trial materials to the US, for use in an NIH funded clinical trial. This clinical trial material is finished good cannabis oil that contains both CBD and THC. To the Company's knowledge, this is the first Phase 2 clinical trial of its kind sourced from a Canadian Licenced Producer.
The complex process relied on MediPharm's GMP Drug Establishment License, product stability data, US FDA Innovative New Drug Approval, and US DEA narcotic import approval. Steps to meet these requirements were initiated five years ago and involved large capital investments, demonstrating a unique pharmaceutical capability and approach that distinguishes MediPharm from other cannabis companies.
This development is significant as the majority of cannabis operators in the US are operating under State specific regulations that prohibits them from manufacturing for FDA sanctioned research activities and DEA approved shipments under federal narcotic laws.
US FDA Status Update
MediPharm completed a US FDA five day in-person inspection from November 21 to 25, 2022. This was initiated in relation to MediPharm's Cannabidiol Active Pharmaceutical Ingredient (API) Drug Master File (DMF) being referenced in an Abbreviated New Drug Application (ANDA) submitted to the FDA in September 2023 by a global pharmaceutical company. Following the inspection, MediPharm was presented with inspection observations. MediPharm has responded in writing to all observations via a corrective action plan. These actions have now been implemented and any additional FDA feedback is expected by way of comments on the Company's DMF and partner's ANDA filings. As this process is completed, MediPharm continues to be a registered foreign drug manufacturing site with the US FDA. The company believes it is the only Canadian Pharmaceutical company or LP with this registration.
This US FDA inspection was the first of its kind for a purpose-built cannabis facility in Canada and rare for a global GMP facility that also manufactures botanical THC. This further solidifies MediPharm's position as a global leader in the pharmaceutical development and production of pharmaceutical cannabinoids. This distinction will enable the company to be a leader in future emerging markets, including drugs containing cannabinoids, international medical cannabis programs, and over the counter CBD as a non-prescription natural health product.
The full acceptance of MediPharm's API DMF, of which the FDA inspection is a major step, allows for a number of commercial opportunities for the Company. This will allow MediPharm to further market cannabidiol API to pharmaceutical companies for new novel drugs, generic drugs, modified generics drugs (FDA 505(b)(2)), and clinical trial materials.
About MediPharm Labs
Founded in 2015, MediPharm Labs specializes in the development and manufacture of purified, pharmaceutical-quality cannabis concentrates, active pharmaceutical ingredients (API) and advanced derivative products utilizing a Good Manufacturing Practices 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 License from Health Canada, becoming the only company in North America to hold a commercial scale domestic Good Manufacturing License 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 via Canna Farms medical ecommerce 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.
Cautionary Note Regarding Forward-Looking Information:
This news release contains "forward-looking information" and "forward-looking statements" (collectively, "forward-looking statements") within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking statements and are based on expectations, estimates and projections as at the date of this news release. Any statement that involves discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as "expects", or "does not expect", "is expected", "anticipates" or "does not anticipate", "plans", "budget", "scheduled", "forecasts", "estimates", "believes" or "intends" or variations of such words and phrases or stating that certain actions, events or results "may" or "could", "would", "might" or "will" be taken to occur or be achieved) are not statements of historical fact and may be forward-looking statements. In this news release, forward-looking statements relate to, among other things, opportunities for future clinical research opportunities and the future supply to the global pharmaceutical industry, future marketable pharmaceutical products, opportunities to be a leader in future emerging markets, and future Canadian and international commercial products that leverage MPL's unique Pharma expertise. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to: general business, economic, competitive, political and social uncertainties; the inability of MediPharm Labs to obtain adequate financing; the delay or failure to receive regulatory approvals; and other factors discussed in MediPharm Labs' filings, available on the SEDAR website at . There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on the forward-looking statements and information contained in this news release. Except as required by law, MediPharm Labs assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change.
SOURCE MediPharm Labs Corp.
