NEW YORK, Aug. 21, 2020 /PRNewswire/ -- Over the past several years, the cannabis industry has reached several milestones to almost completely redefine itself. Now, medical cannabis is predominantly being used to alleviate symptoms associated with afflictions such as chronic pain, cancer, and epilepsy. Positive data has even led many U.S. states to legalize medical cannabis, as CBD products in particular have become more popular and well-known due to their lack of psychoactive effects many associate with cannabis. For example, in a survey conducted by HelloMD and Brightfield Group, approximately 60% out of 2,400 patients said that CBD participants used the compound to successfully treat insomnia or other sleep problems. Meanwhile, 42% percent of CBD users stopped using traditional medications and now use cannabis instead, and 80% of CBD users found CBD be very or extremely effective for treatment. MediPharm Labs Corp. (OTC: MEDIF) (TSX: LABS), Neptune Wellness Solutions Inc. (NASDAQ: NEPT) (TSX: NEPT), Amyris, Inc. (NASDAQ: AMRS), Aurora Cannabis Inc. (NASDAQ: ACB) (TSX: ACB), Aphria Inc. (NASDAQ: APHA) (TSX: APHA).
Currently, the medical cannabis sector accounts for the majority of the market share, and progress is slowly being made in removing the stigmas associated with such products. For instance, the U.S. Food and Drug Administration approved the first marijuana-derived drug to treat epilepsy, Epidiolex. The drug is a cannabidiol, or CBD, based oral solution used to treat seizures associated with epilepsy. While the FDA did move to delist CBD as a Schedule 1 drug, the agency has not approved of any other cannabis-derived treatments or methods of consumption. "We need to derive more value for the market. Given the hundreds of compounds the plant's genetics produce, and our relative lack of knowledge about them and their interactions, there is huge potential for growth in condition-specific treatments and functional delivery," says Liam McGreevy, Chief Executive Officer of Ethnopharm, "The hope is to produce more effective medicines for the patients looking for solutions to their conditions."
MediPharm Labs Corp. (OTCQX: MEDIF) (TSX: LABS) announced breaking news earlier this week that, "its Australian operation – MediPharm Labs Australia Pty. Ltd. ("MediPharm Labs Australia") – has received an important enabling amendment to its Good Manufacturing Practice ("GMP") Certification and Licence to Manufacture Therapeutic Goods.
The licence expansion, granted under Section 40B of the Australian Therapeutic Goods Act 1989 by the Therapeutic Goods Administration of the Australian Government's Department of Health, provides MediPharm Labs with the ability to manufacture Active Pharmaceutical Ingredient ("API") derived from cannabis and cannabis intermediates – such as resins, extracts and isolates – as well as medicinal cannabis finished products including oral liquids, soft-gel capsules and oil. This is one of very few licenses of its kind for dedicated medicinal cannabis manufacture in Australia.
MediPharm Labs Australia is poised to service the entire Australian patient population. July was a record month in Australia with over 5560 SAS-B medical cannabis approvals, an increase of 20% from June (4,630). As of 31 July 2020, the TGA approved over 56,000 SAS Category B applications for unapproved medicinal cannabis products(1). At current levels, MediPharm Labs anticipates more than 70,000 patient approvals could be achieved by the end of 2020.
'This licence amendment paves the way for MediPharm Labs Australia to immediately begin using our facility as it was intended: to manufacture the highest quality APIs and finished medical cannabis formulations for our rapidly growing base of customers,' said Warren Everitt, CEO, Asia Pacific, MediPharm Labs. 'We are extremely proud of this achievement and the MediPharm Labs Australia team that made it happen as it reflects our longstanding commitment to GMP standards and pharma principles of production.'
MediPharm Labs Australia was certified by the Therapeutic Goods Administration ("TGA") as meeting GMP quality standards of practice and secured a Licence to Manufacture Therapeutic Goods in May 2020 and is already generating revenue. MediPharm Labs Australia reported over $600,000 revenue in Q2 2020 from the final packaging of products, originally bulk manufactured in its Canadian headquarters, for sale to Australian customers. As the Company's Canadian facility was TGA GMP certified in late 2019, MediPharm Labs boasts a global pharmaceutical-quality supply chain that is qualified to serve emerging medical markets internationally.
'Whether we manufacture in Canada or now Australia, or a combination thereof, for our current worldwide demand, MediPharm Labs meets the most rigorous standards set out by established health authorities and this licence update serves as another reminder of that very important fact,' said Pat McCutcheon, Chief Executive Officer of MediPharm Labs. 'As a multi-jurisdictional GMP-certified producer, licences such as this differentiate us in the marketplace, serve as a door-opener to sophisticated new pharma and consumer packaged goods customer accounts and represent a highly sought after, valuable and irreplaceable asset that we will protect. Now that we have the green light to manufacture a variety of products and formulations in Australia, we intend to make the most of our first-mover advantage.'
MediPharm Labs also holds Australian Office of Drug Control (ODC) Import and Export Licences covering cannabis resin and extracts, bulk medicinal cannabis oil and finished medicinal cannabis products. It received State Licences for cannabis substances from the Department of Health and Human Services in Victoria, Australia in December 2019 when it completed construction of its manufacturing facility.
MediPharm Labs Australia features multi-phase supercritical CO2 extraction equipment, clean rooms and testing laboratories. The Company also has capabilities to manufacture soft gels, oral liquids and oils and API. It was modelled on the Company's state-of-the-art facility in Barrie, Ontario."
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Neptune Wellness Solutions Inc. (NASDAQ: NEPT) (TSX: NEPT) specializes in the extraction, purification and formulation of health and wellness products. The Company has in excess of 100 customers across several verticals including legal cannabis and hemp, nutraceutical and consumer packaged goods. Late last year the Company announced that it had entered into a collaboration agreement with International Flavors & Fragrances Inc. (IFF) to co-develop hemp-derived CBD products for the mass retail and health & wellness markets. App Connect Service, Inc. is also a party to the agreement to provide related branding strategies and promotional activities. "We are pleased to enter this strategic partnership and drive innovation that satisfies customers' demands for quality, sustainability and traceability," said Nicolas Mirzayantz, Divisional CEO, Scent at IFF. "The hemp-derived CBD products we are developing will target consumer preference towards natural health & wellness products."
Amyris, Inc. (NASDAQ: AMRS), a global science and technology leader of pure, sustainable ingredients for the Health & Wellness, Clean Beauty and Flavors & Fragrances markets, announced back in March clinical data showcasing the superiority of its natural sugarcane squalane (marketed and sold as Neossance Squalane) as a carrier of CBD versus other oils. In order for CBD to be effective in topical applications, skin penetration is a key factor. Amyris sugarcane squalene improves the efficacy of CBD by 10-40X as the carrier oil chassis for the skin care market based on new data. Amyris is developing CBD through fermentation technology and believes it will be the first company to provide highly pure and efficacious CBD from this technology at commercial scale. The ability to provide both high quality CBD and the best performing carrier chassis will provide consumers with greater choice and product effectiveness. The company has filed a patent application covering the use of squalane to deliver cannabinoids, including CBD, to the skin to protect its distinctive advantage.
Aurora Cannabis Inc. (NASDAQ: ACB) (TSX: ACB) reported earlier in May that it had completed the previously announced acquisition of Reliva, LLC a leader in the sale of hemp-derived CBD products in the United States for approximately USD 40 Million of Aurora common shares. The transaction also includes a potential earn-out of up to a maximum of USD 45 Million payable at Aurora's option in shares or cash contingent upon Reliva achieving certain financial targets over the next two years. "We are pleased to have closed the Reliva transaction ahead of schedule. The partnership between Aurora and Reliva is expected to create a market leading international cannabinoid platform that we believe can deliver robust revenue and profitable growth," said Michael Singer, Executive Chairman and Interim CEO of Aurora. "I would like to officially welcome Miguel Martin and his team to Aurora, and look forward to increasing Aurora's operating scale, international reach, and product and brand diversity while in parallel, we remain focused on delivering Adjusted EBITDA profitability in Canada for the benefit of all shareholders."
Aphria Inc. (NASDAQ: APHA) (TSX: APHA) announced last year that it had received a cultivation license from Health Canada for Aphria Diamond, the Company's second Leamington, Ontario cannabis greenhouse facility, bringing an additional 1,300,000 sq. ft. of production space with an annual growing capacity of 140,000 kg. Combined with the Company's Aphria One facility and its subsidiary Broken Coast Cannabis, the Company now has more than 2,400,000 sq. ft. of cultivation space capable of reaching a total annualized production capacity of 255,000kg. "We are extremely pleased to receive the licence for our long-awaited Aphria Diamond facility, which more than doubles our Canadian production capacity," said Irwin D. Simon. "Reaching industry-leading production levels coinciding with the expansion into new categories and new opportunities for cannabis in Canada and around the world is a transformative moment for Aphria Inc."
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