MediPharm Labs Enters United States Pharmaceutical Market with Submission of FDA DMF

Rhea-AI Summary

MediPharm Labs has completed a Drug Master File (DMF) for its CBD Active Pharmaceutical Ingredient (API) with the US FDA, allowing it to supply approved APIs to pharmaceutical firms engaged in late-stage research. This move targets a cannabis-based drug market projected to exceed USD $25 billion by 2025, marking MediPharm as the only Canadian company with such FDA approval and the second for natural CBD DMF in North America. The company aims to position itself as a leading supplier and leverage its GMP manufacturing platform to capture market share.

Positive

• Completion of a Drug Master File (DMF) for CBD API with the US FDA, expanding commercial opportunities.
• Positioning in a projected USD $25 billion cannabis drug market by 2025.
• Unique standing as the only Canadian company with an FDA DMF for CBD and the second in North America.

Negative

• None.

• Completed a Drug Master File ("DMF") process for CBD Active Pharmaceutical Ingredient ("API") for the US Federal Drug Administration ("FDA").
  
  
• Use of Canadian Drug Establishment Licence ("DEL") to register API with the FDA for commercial opportunities in pharmaceutical development, novel drugs and generic drugs.
  
  
• The cannabis-based drug opportunity is predicted to be over USD$25 billion by 2025⁽ⁱ⁾.
  
  
• This is the only US FDA for CBD by a Canadian company and the second natural CBD DMF at commercial scale in all of North America⁽ⁱⁱ⁾.

TORONTO, Feb. 23, 2022 /PRNewswire/ - MediPharm Labs Corp. (TSX: LABS) (OTCQX: MEDIF) (FSE: MLZ) ("MediPharm" or the "Company") a pharmaceutical company specialized in precision-based cannabinoids, is pleased to announce it has completed a US FDA DMF for pure natural CBD API. The DMF will enable MediPharm to supply approved API to pharmaceutical companies currently conducting late-stage research. The cannabis-based drug opportunity is predicted to be over USD$25 billion by 2025, and there are over 20 strong novel cannabinoid-based drugs currently in the late-stage research process. These projects will all require pharmaceutical approved API if commercialized. MediPharm has already shipped good manufacturing practice ("GMP") CBD for development purposes to multiple established pharmaceutical companies.

Management Commentary

Bryan Howcroft, CEO, MediPharm, commented, "The filing of a US DMF further advances MediPharm toward its ultimate objective of becoming a dominant supplier of API to pharmaceutical companies. This is a high value, high margin opportunity, and with the only purpose-built facility in North America to receive a domestic GMP licence specifically for the extraction of natural cannabinoids, MediPharm is positioned to capture share in this growing market. In the short to medium term, the DMF unlocks new sales channels and will enable us to further leverage the investments made to date on our high-quality pharmaceutical manufacturing platform. Over the longer-term, it ensures the Company is positioned as the go-to cannabinoid partner for pharmaceutical companies around the world."

Additional Information

DMFs are regulatory submissions filed with the FDA containing confidential, detailed information about manufacturing, processes, packaging, and stability of APIs to be used in medicinal products for human use. Once the DMF filing is accepted by the FDA, pharmaceutical companies can reference the DMF when making a regulatory submission.

There are many large commercial opportunities for an API in new drug applications ("NDAs") and abbreviated new drug applications ("ANDAs"). NDAs and ANDAs can be divided into the following four categories:

1. A standalone NDA for new novel drugs.
   
   
2. A 505(b)(2) application is a NDA where at least some of the information required for approval comes from studies not conducted by or for the applicant.
   
   
3. An ANDA for a previous approved drug creating a new generic drug.
   
   
4. A petitioned ANDA is a type of ANDA for a drug product that differs from the novel drug in dosage form, route of administration, strength, or active ingredient.

About MediPharm Labs

Founded in 2015, MediPharm specializes in the development and manufacture of purified, pharmaceutical-quality cannabis concentrates, API and advanced derivative products utilizing a Good Manufacturing Practices certified facility with ISO standard-built clean rooms. MediPharm 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 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 received a DEL from Health Canada, becoming the only company in North America to hold a domestic GMP 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: acceptance of the DMF by the FDA and timing thereof; registering API with the FDA for commercial opportunities in pharmaceutical development, novel drugs and generic drugs; predictions regarding the cannabis-based drug opportunity; supplying approved API to pharmaceutical companies currently conducting late-stage research; becoming a dominant supplier of API to pharmaceutical companies; unlocking new sales channels; enabling the Company to further leverage the investments made to date on its high-quality pharmaceutical manufacturing platform; and positioning the Company as the go-to cannabinoid partner for pharmaceutical companies around the world. 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 to obtain adequate financing; the delay or failure to receive regulatory approvals; and other factors discussed in MediPharm's 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 assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change.

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i Prohibition Partners

ii FDA 2021 Q4 report

 

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SOURCE MediPharm Labs Corp.

FAQ

What is the significance of MediPharm's DMF submission to the FDA?

The DMF submission allows MediPharm to supply approved CBD APIs to pharmaceutical companies for late-stage drug research, enhancing its market position.

How does MediPharm plan to capitalize on its FDA DMF for CBD?

MediPharm aims to leverage its DMF to unlock new sales channels and establish itself as a dominant supplier of cannabinoid APIs in the pharmaceutical sector.

What market opportunity does MediPharm aim to capture with its CBD API?

MediPharm targets a cannabis-based drug market expected to exceed USD $25 billion by 2025, focusing on various drug applications.

When did MediPharm announce its DMF completion to the FDA?

MediPharm announced the completion of its DMF to the FDA on February 23, 2022.

What distinguishes MediPharm's DMF from others in North America?

MediPharm's DMF is notable for being the only one by a Canadian company and the second natural CBD DMF at a commercial scale in North America.