MediPharm Labs Enters Landmark Commercial Agreement with Laboratório Teuto in Brazil

Rhea-AI Summary

MediPharm Labs (TSX: LABS, OTCQX: MEDIF) has secured a commercial agreement with Laboratório Teuto, a major Brazilian pharmaceutical manufacturer. ANVISA granted Teuto Sanitary Authorizations for two MediPharm-manufactured products on December 30, 2024, with initial shipments expected to begin after receiving import and export permits.

The Brazilian medical cannabis market, estimated to be worth $198 million in 2024 with over 670,000 patients, is growing at over 20% annually and projected to exceed $260 million by 2026. Teuto, with 77 years of industry experience, operates a 140,000-square-meter facility producing over 500 pharmaceutical products annually.

MediPharm is among few North American companies with multiple ANVISA sanitary authorizations and an ANVISA GMP license. Currently, only 36 valid cannabis product authorizations exist under RDC 327/2019 in Brazil's strictly regulated market.

Positive

• Secured commercial agreement with one of Brazil's largest pharmaceutical manufacturers
• Received ANVISA approval for two products in Brazil's $198M medical cannabis market
• Among few North American companies with multiple ANVISA authorizations
• Targeting a market growing 20% annually, projected to reach $260M by 2026
• Partnership with Teuto provides access to extensive distribution network and national sales force

Negative

• Initial shipments pending regulatory permits from ANVISA and Health Canada
• Operating in highly regulated market with extensive approval requirements

• MediPharm Labs expands its Brazilian presence where the medical cannabis market is estimated to be worth $198 million in 2024, serving over 670,000 patients.¹
• Products include full-spectrum, GMP sublingual oral solutions with extensive pharmaceutical validation and characterization.
• Teuto is one of Brazil's largest pharmaceutical manufacturers of both generic and branded medicines, with an extensive portfolio of oncologic specialty drugs, making it an ideal partner for MediPharm.

BARRIE, ON, Jan. 8, 2025 /PRNewswire/ - MediPharm Labs Corp. (TSX: LABS) (OTCQX: MEDIF) ("MediPharm" or the "Company"), a leader in pharmaceutical-grade cannabis manufacturing, is proud to announce a commercial agreement with Laboratório Teuto ("Teuto"), a leading pharmaceutical manufacturer and marketer in Brazil. This partnership signifies a significant milestone as MediPharm expands its reach into one of the most tightly regulated medical cannabis markets globally.

ANVISA Product Approval Marks Commercial Milestone Achievement

ANVISA (Agência Nacional de Vigilância Sanitária) granted Teuto Sanitary Authorizations for two products manufactured by Medipharm. The approvals, published on December 30, 2024, mark the culmination of a rigorous process that underscores MediPharm's commitment to compliance, quality, and innovation in the global medical cannabis space. MediPharm and Teuto have been working closely together on the ANVISA approvals, which included pharmaceutical-level product filings, extensive quality control documentation, and responding to multiple requests for information over many months. Initial Shipments are expected to begin in the new year after applicable import and export permits from ANVISA and Health Canada are received.

Brazil's medical cannabis market is known for its stringent regulatory requirements, including:

• ANVISA onsite GMP Inspections: Ensuring adherence to the highest pharmaceutical standards.
• Comprehensive Product Dossier Submissions: Requiring a minimum of 12 months of stability testing and rigorous quality assurance.
• Extended Product Approval Timelines: Reflecting Brazil's commitment to patient safety and product efficacy.

There are currently only 36 valid cannabis product authorizations issued by ANVISA under RDC 327/2019.²

MediPharm Labs is one of just a few North American companies with products to receive multiple sanitary authorizations for cannabis products while holding an ANVISA GMP licence. The Brazilian medical cannabis market is growing over 20% annually and is projected to exceed $260 million by 2026.³ Teuto can use its existing deep roots in Brazil and sales and marketing expertise to position itself as a leader in pharmaceutical cannabis.

Teuto: A Trusted Partner in Brazil

Teuto, a household name for trusted medicines in Brazil, boasts over 77 years of industry leadership. As one of the largest pharmaceutical companies in the country, Teuto operates a state-of-the-art manufacturing facility spanning over 140,000 square meters and produces more than 500 pharmaceutical products annually.⁴ Teuto's extensive distribution network, national sales force and commitment to quality make it an ideal partner for MediPharm as the Company brings pharmaceutical-grade cannabis solutions to Brazilian patients. This agreement reflects MediPharm's strategic focus on leveraging its pharmaceutical GMP-certified platform to expand globally into large, complex and highly regulated markets. MediPharm's expertise aligns seamlessly with Teuto's vision to provide innovative healthcare solutions to the Brazilian market, including over 215 million people.

Management Commentary

"Globally, we believe that the higher the regulatory bar, the more complex and stringent the quality standards are in a country, the better for MediPharm. Brazil is a perfect example of a large complex market, and we are very fortunate to have a long-term partnership with Teuto, one of the leading Brazilian pharmaceutical companies." said David Pidduck, CEO at MediPharm Labs.

"Medical cannabis is an important product for our line of Specialty Care, increasing our relationship with physicians, completing our CNS portfolio and Oncology on palliative care. Our partnership with MediPharm will allow TEUTO to grow faster in this market, bringing more full-spectrum products with the highest quality to Brazilian patients in need." said Marcelo Henriques, CEO of Teuto.

About Laboratório Teuto

Established in 1947, Teuto is a pioneering pharmaceutical company in Brazil, dedicated to delivering high-quality medicines and healthcare solutions. Known for its innovation and trust, Teuto has become a cornerstone of Brazil's healthcare ecosystem.

Teuto works incessantly to maintain its products in perfect condition. The company, which is synonymous with quality and confidence at affordable prices, constantly seeks to provide more quality of life to its clients, employees, and partners, reaffirming that "If its Teuto, its trustworthy".

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 Practices License for the extraction of multiple natural cannabinoids. This GMP license was the first step in the Company's current foreign drug manufacturing site registration with the US FDA.

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.

The Company carries out its operations in compliance with all applicable laws in the countries in which it operates.

Website: www.medipharmlabs.com

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, MediPharm's access to and unique position in the international medical markets, Remidose project capital expenses, future revenue growth in Germany and internationally, customer product authorizations, German cannabis market growth, margin related to international product and MediPharm'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 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.

1 Kaya, Medicinal Cannabis Yearbook 2024, Kaya Mind Dados e Pesquisas LTDA. https://kayamind.com/anuario-da-cannabis-medicinal-2024/

2 Brazilian Health Regulatory Agency (2025, January 7). Consultations https://consultas.anvisa.gov.br/#/cannabis/q/?situacaoRegistro=V

3 Kaya, Medicinal Cannabis Yearbook 2024, Kaya Mind Dados e Pesquisas LTDA.

4 Laboratório Teuto (2025, January 7). Corporate website, https://www.teuto.com.br/

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SOURCE MediPharm Labs Corp.

FAQ

What is the value of the Brazilian medical cannabis market where MEDIF is expanding?

The Brazilian medical cannabis market is estimated to be worth $198 million in 2024 and is projected to exceed $260 million by 2026, growing at over 20% annually.

How many ANVISA cannabis product authorizations has MEDIF received in Brazil?

MediPharm Labs received ANVISA Sanitary Authorizations for two products on December 30, 2024, making it one of few North American companies with multiple authorizations.

When will MEDIF begin shipping products to Brazil through Teuto partnership?

Initial shipments are expected to begin in the new year after receiving applicable import and export permits from ANVISA and Health Canada.

What is the size of Teuto's manufacturing facility partnering with MEDIF?

Teuto operates a state-of-the-art manufacturing facility spanning over 140,000 square meters and produces more than 500 pharmaceutical products annually.

How many patients does the Brazilian medical cannabis market serve where MEDIF is expanding?

The Brazilian medical cannabis market serves over 670,000 patients as of 2024.