• MediPharm Labs shares progress on clinical trials, including the provision of clinical trial materials and research support to multiple partners.
  • Research support consists of both product and services for partner studies across various indications.
  • MediPharm Labs participation ranges from full drug development support to FDA approved clinical trial materials.
  • MediPharm Labs GMP Drug Establishment License, DMF capability, Natural Health Products licence and Cannabis Drug Licence in addition to its FDA registered facility positions the Company with unique capabilities to support trials globally including the US.

TORONTO, March 1, 2023 /PRNewswire/ - MediPharm Labs Corp. (TSX: LABS) (OTCQX: MEDIF) (FSE: MLZ) ("MediPharm Labs" or the "Company") a pharmaceutical company specialized in precision-based cannabinoids, is pleased to provide an update on significant progress made in the field of cannabis research.

MediPharm Labs Logo (CNW Group/MediPharm Labs Corp.)

MediPharm remains focused on investing in clinical research and supporting the development of future cannabis derived pharmaceutical drugs. Consistent with this commitment, the Company will supply the Sponsor and investigators with cannabis-derived study drugs, placebos, and other services and assistance as may be required during the course of the studies.  The following update provides current milestone achievements of notable projects.

Researcher

Indication

Phase

Recent Milestone

USC (University of Southern California) Keck School of Medicine

Treatment of Alzheimer's Agitation Disorder

Two

FDA approval of Investigational New Drug (IND)

McMaster University

Treatment of post-surgical pain

Two

Clinical trial material (CTM) delivered and enrollment commencing in Q1 2023

University Health Network - Toronto

Improving Pain Disability With The Use Of Oral Cannabinoids

Pilot

CTM Delivered and enrollment clinic in Q1 2023

McMaster University

Insomnia in depressive disorder

Two

CTM   Shipment  in Q1 2023

Centre for Medical Cannabis Research

PK of single dose THC/CBD in healthy adult controls and kidney disease

One

1st patient dosed January 2023

University of Manitoba

Chronic Headaches in Adolescents

Two

Health Canada approval Dec 2022. CTM shipment in Q1 2023


In addition to these institutionally led studies, the Company is also providing API and clinical trial material to various pharmaceutical companies for commercial projects involving cannabis-derived drugs. The timelines for both institutional and industry research are long by nature with positive outcomes uncertain.  

MediPharm has been selected by these researchers based on the US and Canadian Regulatory requirements for pharmaceutical GMP manufactured clinical trial materials. MediPharm is uniquely positioned as a Pharmaceutical grade supplier due to its Health Canada GMP Drug Establishment Licence (DEL); Cannabis Drug Licenses; US FDA DMF experience; and medical cannabis formulations expertise. Since the company's founding, it has invested tens of millions of dollars to establish itself as the preferred partner for pharma companies looking to add drugs containing cannabis to their pipelines. The Company expects to support further clinical trials in the US, Canada and other countries. Success in producing and delivering cannabis study drug in Canada and now approvals to supply US studies, demonstrate that we have the pharmaceutical quality and regulatory standards required to address complex US national and state specific regulations.

With existing infrastructure and expertise MediPharm will continue to invest in all aspects of the pharmaceutical cannabis research spectrum, from new drug development to early-stage academic research.  The Company looks forward to providing further updates on project milestones as our research programs progress.  

Management Commentary

David Pidduck, CEO, MediPharm Labs commented, "Commitment to pharmaceutical cannabis research has been a founding principle of the company since its inception. It's in our name - that medical and pharmaceutical insights will be core investment areas. We are proud to participate in and support these many important research and drug development initiatives with multiple Pharma and Academic partners."

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 with five primary extraction lines for delivery of pure, trusted and precision-dosed cannabis products for its customers. Through its wholesale and white label platforms, MediPharm Labs formulates, develops (including through sensory testing), processes, packages and distributes cannabis extracts and advanced cannabinoid-based products to domestic and international markets.

In 2021, MediPharm Labs received a Pharmaceutical Drug Establish License from Health Canada, becoming the only company in North America to hold a domestic Good Manufacturing License for the extraction of natural cannabinoids. The Company carries out its operations in compliance with all applicable laws in the countries in which it operates.

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, statements regarding: the expected results of any clinical research, being a low-capital avenue to research and future marketable pharmaceutical products, target further similar projects, creating an opportunity for future patient and physician education based on trial outcomes, expecting to support further clinical trials in Canada and other countries, continuing to scale its clinical trial support business without the need for additional capital, and that medical and pharmaceutical insights will be core investment areas in the future.  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 www.sedar.com. 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.

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SOURCE MediPharm Labs Corp.

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