NEW YORK, Sept. 25, 2020 /PRNewswire/ — The legalization of cannabis in several countries is one of the key factors driving the market’s growth. In addition, the use of cannabis for medical purposes is gaining momentum worldwide. Medical cannabis products are used for the treatment of various chronic conditions such as cancer, arthritis, and neurological conditions, as well as anxiety, depression, epilepsy, as well as Parkinson’s and Alzheimer’s disease. This year, the elections across the country will help determine the future of cannabis products in several states and could have an influence on the federal legalization in the future. According to Leafy, six states will be voting on legalization this November, with four states are voting on adult-use (recreational) cannabis legalization: Arizona, Montana, New Jersey, and South Dakota. Two states are voting on medical marijuana legalization: Mississippi, and South Dakota. Oregon voters will consider two separate drug reform measures. One would legalize the medical use of psilocybin. The other would decriminalize small amounts of all drugs. MediPharm Labs Corp. (OTC: MEDIF) (TSX: LABS), HEXO Corp. (NYSE: HEXO), Zynerba Pharmaceuticals, Inc. (NASDAQ: ZYNE), OrganiGram Holdings Inc. (OGI), GW Pharmaceuticals plc (NASDAQ: GWPH)
The increasing popularity of CBD is mainly credited to various medical applications that are associated with the products. Currently, CBD is sonly approved by the U.S. Food and Drug Administration to treat epilepsy. On the other hand, following the de-scheduling of CBD by the U.S. Drug Enforcement Administration last year, more people are using CBD as an over-the-counter medication or treatment. “While there continues to be uncertainty and a healthy amount of confusion around hemp cultivation for CBD production, it is clear that demand is nonetheless continuing to rise across the U.S.,” noted Giadha Aguirre de Carcer, New Frontier Data CEO and Founder. “As states issue more licenses, consumer demand increases, and mass-market retailers such as CVS and Walgreens continue to expand their own product offerings, we expect the FDA may be forced to provide further regulatory clarifications sooner rather than later.”
MediPharm Labs Corp. (OTCQX: MEDIF) (TSX: LABS) announced breaking news earlier this week that, “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.'”
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HEXO Corp. (NYSE: HEXO) reported in July the launch its line of vape products to both adult-use and medical consumers, across Canada. “At HEXO, we pride ourselves in ensuring our consumers have access to high-quality, reliable and consistent cannabis products,” said Sebastien St. Louis, CEO and co-founder of HEXO Corp. “We are thrilled to launch our vape products across Canada as we continue to focus on innovation and launching additional 2.0 products across all of our brands.” Prior to releasing its line of vapes, the Company conducted testing to evaluate the taste, tolerability of effects and short-term undesired effects of its proprietary terpene blends. HEXO’s vape products currently include three ready-to-use vape pens and four 510-thread cartridges, in popular strain-inspired terpene blends.
Zynerba Pharmaceuticals, Inc. (NASDAQ: ZYNE) announced last week that the U.S. Food and Drug Administration has granted orphan drug designation for cannabidiol (CBD) for use in treating 22q11.2 deletion syndrome (22q). 22q is a rare midline condition featuring physical abnormalities and debilitating neuropsychiatric and behavioral symptoms including anxiety, withdrawn behavior, and social interaction problems. “Zynerba is committed to developing Zygel™ CBD gel in certain rare and near-rare conditions, including 22q, for which there is an urgent need for new, innovative therapeutics,” said Armando Anido, Chairman and Chief Executive Officer of Zynerba. “We are pleased that the FDA shares our sense of urgency regarding the development of effective therapeutics in this important patient population. The receipt of this designation represents another important milestone for us, and we look forward to working closely with the FDA to develop Zygel in pediatric and adolescent patients with 22q as expeditiously as possible.”
OrganiGram Holdings Inc. (OGI) the parent company of Organigram Inc. announced back in August that it has partnered with Medical Cannabis by Shoppers™ (“Shoppers”) on Phase 2 of Shoppers’ Pilot Program powered by software partner TruTrace Technologies Inc. The program is designed to genetically finger-print all participating cannabis products, tracking them throughout the supply chain, from genome to patient, in order to provide real-time information about the composition of each cannabis product used by Medical Cannabis by Shoppers customers. Organigram will provide cannabis products to Shoppers for use in the tracking program. “Organigram is proud of our long-standing commitment to our medical cannabis community. From the development of innovative products to the support offered by our patient care team and programs, patients and their needs are at the heart of our medical cannabis business,” says Greg Engel, CEO, Organigram. “We also recognize how critical consistency is to patients and their healthcare providers so are pleased to partner with Shoppers, providing our products so that they can be followed from raw material to finished product, to offer them important, useable product insights.”
GW Pharmaceuticals plc (NASDAQ: GWPH) reported this week that the Australian Therapeutic Goods Administration (TGA) has approved EPIDYOLEX® (cannabidiol) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age and older. This represents GW’s cannabis-based medicine’s third global regulatory approval, following US Food and Drug Administration (FDA) approval in 2018 and European Commission (EC) approval in 2019. GW has partnered with Chiesi Australia to make this medicine available in Australia, and the Company will now work alongside its partner and Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) to secure reimbursement for the medicine through a listing on the Pharmaceutical Benefits Scheme (PBS). “GW was founded over two decades ago with a mission to bring cannabis-based medicines to patients with an unmet medical need. We are proud to now be able to bring GW’s cannabidiol to patients in Australia following this approval and our partnership with Chiesi Australia,” said Chris Tovey, GW’s Chief Operating Officer. “This marks our third global regulatory approval and is another important step for GW and the patients we are here to support. The TGA approval is further proof that cannabis-based medicines can successfully go through extensive randomised placebo-controlled trials and a rigorous evaluation process to reach patients who need them.”
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