MediPharm Labs Provides Update on Clinical Trial Progress Including FDA Approval of Partner Study

Rhea-AI Summary

MediPharm Labs Corp. (TSX: LABS, OTCQX: MEDIF) announced significant advancements in cannabis research, providing clinical trial materials and support to multiple partners. The company has obtained FDA approval for an Investigational New Drug to treat Alzheimer's Agitation Disorder. MediPharm has also delivered clinical trial materials for studies on post-surgical pain and insomnia in depressive disorders. With its GMP Drug Establishment License and FDA registered facility, the company is positioned to support global trials. MediPharm continues to invest in developing cannabis-derived pharmaceutical drugs and aims to support further clinical trials across North America.

Positive

• FDA approval for an Investigational New Drug for Alzheimer's Agitation Disorder.
• Successful delivery of clinical trial materials for multiple studies.
• Strong infrastructure with GMP licensing enhances global trial support.

Negative

• None.

• 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 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.

FAQ

What is the significance of the FDA approval received by MediPharm Labs?

The FDA approval allows MediPharm Labs to proceed with clinical trials for treating Alzheimer's Agitation Disorder, marking a critical step in drug development.

What clinical trials is MediPharm Labs currently supporting?

MediPharm Labs is supporting trials for Alzheimer's Agitation Disorder, post-surgical pain, insomnia in depressive disorders, and more.

What are the capabilities of MediPharm Labs in the context of clinical trials?

MediPharm Labs holds a GMP Drug Establishment License and FDA registered facility, enabling it to supply high-quality clinical trial materials and support.

How is MediPharm Labs positioned in the cannabis pharmaceutical market?

MediPharm Labs is uniquely positioned due to its experience with US and Canadian regulatory requirements, making it a preferred partner for pharmaceutical companies in cannabis research.