— MediPharm Labs Corp. (TSX: LABS) (OTCQX: MEDIF) (FSE: MLZ) (“MediPharm Labs” or the “Company”) a global leader in specialized, research-driven pharmaceutical-quality cannabis extraction, distillation and derivative products, today announced its wholly owned subsidiary MediPharm Labs Inc. will supply premium, GMP-certified formulated cannabis oil to XLR8 BRAZIL (“XLR8”), a Rio de Janeiro based value-added distributor serving Brazil, Latin America’s largest medical cannabis market.
Under the two-year agreement commencing from the time of product authorization, MediPharm Labs Inc. will provide a variety of cannabis concentrate formats for patient-ready formulated products that will be distributed by XLR8 to leading pharmacies and other authorized channels in Brazil. The initial product SKUS include a 20:1 CBD rich product and a 10:10 balanced THC and CBD formulation. XLR8 will obtain ANVISA Sanitary Product Authorization and undertake the process for final Product Registrations.
“By virtue of its large population, forward-thinking legislative eco-system and economic strength, Brazil is one of the world’s most promising medical cannabis markets and the natural next port of call for our international expansion and growth strategy,” said Pat McCutcheon, CEO of MediPharm Labs. “Given Brazil’s potential as one of our key target markets, we have chosen to partner with XLR8 because of their focus on quality and compliance, their extensive relationships with local healthcare professionals and dedicated focus on the advancement of medical cannabis scientific validation and education. They are the perfect complement to and outlet for our pharma-quality production.”
This is MediPharm Labs’ second distribution agreement in Latin America and evidence of growing international momentum with its strategy of targeting emerging jurisdictions that offer excellent opportunity for sustainable revenue expansion.
“As early participants in the Brazilian medical cannabis industry dating back to its involvement in the pioneering import of medical cannabis oil for patient use from Canada to Brazil in 2017, XLR8 is pleased to have entered into this supply agreement with one of the only PIC/S GMP certified manufacturers of medical cannabis derivatives,” says Mike Dacks of Type 2 Ventures who acts as a strategic advisor to XLR8. “We look forward to bringing these products to market and to working with ANVISA as well as our ecosystem of local partners to bring the required clinical validation for final Product Registrations under the new Brazilian legislative framework.”
“In our view, Brazil is destined to be a global powerhouse in medical cannabis,” said Thiago Callado, Founder and CEO of XLR8. “To make this exciting future a reality, Brazilians need reliable access to formulations that are constructed using proven methodologies that meet the most rigorous international standards of care. By aligning with MediPharm Labs, a company that has GMP certification, the veritable gold seal in pharma-grade production, XLR8 can now begin to fulfill our mission of market leadership.”
About Brazil’s Market
Using a range of pricing, consumption and patient datasets, the LATAM Cannabis Report™ by Prohibition Partners(1) forecasts that the LATAM market is expected to exceed US$12 billion by 2028, offering “serious growth potential to global cannabis companies.” Today, Brazil is the region’s largest addressable market with a population of nearly 210 million, and according to Prohibition Partners, Brazil could potentially have one of the world’s highest potential patient counts.
In December 2019, Brazil established a new legalized environment for the sale and consumption of cannabis for medical use. As part of the announcement by the National Agency for Health Surveillance of Brazil (“ANVISA”), a new class of medical cannabis products can be prescribed by doctors and sold through pharmacies, enabling safe and legal patient access.
The regulatory framework, valid for an initial three-year term, governs the manufacture and import of medical cannabis products as well as the requirements for commercialization, prescription, dispensing, monitoring and supervision. ANVISA’s rules apply to medicines whose therapeutic indication is restricted to patients with severe and/or life-threatening debilitating diseases and without alternative therapy.
Since 2015, ANVISA has allowed for the importation of cannabidiol-based medicines and other cannabinoids for “compassionate use”.
MediPharm Labs’ facilities were recently certified by the Australian Therapeutic Goods Administration (“TGA”) as meeting the GMP standard of production. The TGA is one of 53-members of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). Many PIC/S members enter into mutual recognition agreements whereby each participating country’s regulatory authority specifically recognizes certain processes and procedures of the other country to expedite the international flow of goods. For cannabis extracts, Brazil requires PIC/S GMP certification for foreign produced goods and recognizes MediPharm Labs’ TGA GMP certification. XLR8 intends to obtain its ANVISA Sanitary Authorization and approvals required for importation.
1) LATAM Cannabis Report™ by Prohibition Partners https://prohibitionpartners.com/wp-content/uploads/2019/07/The-LATAM-Cannabis-Report%E2%84%A2.pdf
About XLR8 Brazil
Headquartered in Rio de Janeiro, XLR8 is a full-service market entry partner for GMP medical cannabis products in Brazil and one of the original pioneering operators in the Brazilian medical cannabis industry. With a focus on differentiated and efficacious products, XLR8 is amongst a small cluster of leading players positioned to take advantage of Brazil’s evolving medical cannabis framework and its focus on clinically validated registered medications.
XLR8 Brazil has previously imported medical cannabis products for compassionate use and submitted all required documentation for the commercial import, storage, distribution and sale of medical cannabis products. Additionally, XLR8 is partnered with strategic resources allowing for immediate importation of compliant medical cannabis products.
About MediPharm Labs
Founded in 2015, MediPharm Labs specializes in the production of purified, pharmaceutical-quality cannabis oil and concentrates 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. As a global leader, MediPharm Labs has completed commercial exports to Australia and has fully commercialized its Australian extraction facility. MediPharm Labs Australia was established in 2017.
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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, the successful performance of the agreement and shipping of products thereunder as planned; distribution by XLR8 of products to leading pharmacies and other authorized channels in Brazil; XLR8 obtaining ANVISA product registrations; forecasts regarding the growth and size of the Brazilian market; and providing further support and commercialization for XLR8 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 http://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.
All information contained in this press release with respect to XLR8 was supplied by XLR8 for inclusion herein.