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Canopy Growth announces completion of study on the long-term effects of CBD

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Canopy Growth Corporation (“Canopy Growth” or the “Company”) (TSX: WEED) (NASDAQ: CGC) and its medical division, Spectrum Therapeutics, have completed and published a new study on the long-term effects of cannabidiol (CBD), specifically focusing on toxicity and lifespan effects of CBD in the preclinical model C. elegans.

The study was commissioned to evaluate the solubility, stability, acute toxicity, thermotolerance, and effects on lifespan of CBD in C. elegans as part of Canopy Growth’s ongoing commitment to provide the data required to support and influence public policy through research. To the best of the Company’s knowledge, this study represents the first long-term toxicity and lifespan research regarding the effects of chronic exposure to cannabidiol – one of the cannabinoids found in cannabis.

Acute and long-term exposure studies of CBD at physiologically relevant concentrations were studied in the worm model Caenorhabditis elegans (C. elegans) on the basis that 60-80% of their genes are shared with humans, and their comparatively short lifespan of 2-3 weeks makes such studies feasible. In the C. elegans model, which is recognized as a valid model for this kind of research, CBD did not demonstrate any degree of acute or life-long toxicity or related liabilities at physiological concentrations. Instead, CBD extended mean lifespan up to 18% and increased late-stage life activity by up to 206% compared to the untreated controls within the study.

“Despite widespread use of CBD, no life-long toxicity studies had been conducted to date to determine the impact – or potential impact – of long-term exposure to CBD,” shared Hunter Land, Senior Director of Translational and Discovery Science at Canopy Growth. “These results serve as the only CBD life-long exposure data in an in vivo model to date, and the absence of long-term toxicity gives us the evidence we need as an industry to continue researching the potential health benefits for the broader application of CBD.”

The study was conducted in partnership with NemaLife Inc., and is published in Cannabis and Cannabinoid Research journal and available online.

While further research into the life-long use of CBD should be carried out in mammalian models, the C. elegans model indicates a lack of long-term toxicity at physiologically relevant concentrations. Canopy Growth and its medical division Spectrum Therapeutics continue to advance a range of research initiatives aimed at furthering the understanding of – and unleashing – the full potential of cannabis.

U.S. rule permitting the import of drugs from Canada prompts Health Canada to release Interim Order prohibiting exports that may risk drug shortages

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The Minister of Health (the Minister) signed the Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply) (the Interim Order), which introduces measures to help alleviate/prevent shortages in Canada’s drug supply additional to those introduced by two previous COVID-19-related Interim Orders: (i) Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in relation to COVID-19 (March 30, 2020, which permits exceptional importation, see article here) and (ii) Interim Order respecting the prevention and alleviation of shortages of drugs in relation to COVID-19 (October 16, 2020, see article here). Accompanying the newest Interim Order are a News ReleaseExplanatory NoteBackgrounderNotice and Guidance Document.

Background

As stated in the Explanatory Note, “Drug shortages are a growing global problem with particular implications for vulnerable markets like Canada. Since 2017, approximately 10-15% of drugs have been in shortage at any given time. Canada is a small market representing 2% of global drug sales that sources 68% of its drugs internationally.”

The U.S. final rule on the Importation of Prescription Drugs, which came into effect on November 30, 2020, creates a pathway to allow U.S. pharmacists and wholesalers to import in bulk certain prescription drugs from Canada. The Interim Order is intended to help prevent bulk importation frameworks, such as the U.S. rule, from causing or worsening a drug shortage in Canada, which would put the health of Canadians at risk. As noted in the Explanatory Note, “Comments received from industry and health interest groups to date are supportive of the government of Canada taking immediate action to address the risk of drug shortages presented by the U.S. rule.”

Interim Order

Under the Interim Order, a drug establishment licence (DEL) holder is prohibited from distributing certain drugs for consumption or use outside Canada unless the DEL holder has reasonable grounds to believe that the distribution will not cause or exacerbate a shortage of the drug. The Guidance Document provides a non-exhaustive list of factors a DEL holder is to consider in making this assessment. If a DEL holder does distribute a drug for consumption or use outside Canada, the DEL holder must create and retain a detailed record of the information that they relied on to determine that such distribution is not prohibited by the Interim Order.

The Interim Order applies to the following drugs for which a drug identification number has been assigned under the Food and Drug Regulations or the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19:

(a) drugs listed in Schedules I, II, III, IV or V of the Controlled Drugs and Substances Act;

(b) prescription drugs;

(c) drugs listed in Schedules C and D of the Food and Drugs Act; and

(d) drugs that may be sold without a prescription, but that are administered only under the supervision of a practitioner.

This list is not limited to drugs affected by the COVID-19 pandemic and encompasses all drugs that are eligible for U.S. bulk importation. The scope of the Interim Order does not extend to over-the-counter drugs, natural health products or drugs for veterinary use, or to drugs manufactured in Canada intended for export that meet the conditions set out in subsection 37(1) of the Food and Drugs Act.

Health Canada may request that a manufacturer or DEL holder provide certain information on a voluntary basis to help assess existing and potential drug shortages. If a response is not received, the Interim Order authorizes the Minister to require a manufacturer or DEL holder to provide information within their control, if the Minister has reasonable grounds to believe the conditions in subsection 4(1) of the Interim Order are met.

Pharmaceutical companies who market drugs in Canada, as well as pharmaceutical companies who license others to market their drugs in Canada, may wish to review their relevant contracts (e.g. with customers, other pharmaceutical companies they collaborate with) to ensure the potential export of their products is sufficiently addressed in light of this development.

Made-in-Canada COVID Testing Now Available

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Biotechnology front-runner LuminUltra is pleased to announce that it has received Health Canada authorization to sell and distribute its GeneCount® COVID-19 RT-qPCR Assay Kit. This authorization allows LuminUltra, the Canadian leader in point-of-need molecular diagnostic testing for over 25 years, to give governments and businesses across the country complete and customizable clinical COVID-19 testing capabilities in addition to its industry-leading environmental surveillance solutions in the fight against the pandemic.

“This new product line gives governments and businesses across Canada the tools they need to deliver a high volume of the most accurate COVID-19 test results possible in under two hours,” said LuminUltra Chairman and CEO Pat Whalen. “With this Health Canada authorization we are now able to expand our efforts in the fight against COVID-19 by providing accurate and fast testing solutions for both remote locations and high-capacity mobile labs.”

LuminUltra’s GeneCount® COVID-19 testing solutions comprise multiple, flexible components that together make up a complete laboratory-grade point-of-need solution, including: sample collection kits; isolation reagents; the COVID-19 assay; and a range of qPCR testing devices and software for simple interpretation of COVID-19 test results with industry-leading accuracy and sensitivity.

The gold standard GeneCount platform provides results on 16 to 96 tests in under two hours per run and includes instruments tailored to two specific needs:

  • Portable, point-of-need devices built into a carrying case that enable up to 16 tests per run to be performed where they are needed; and
  • High capacity, automated devices that enable up to 96 tests per run ideal for both mobile and traditional brick-and-mortar laboratories.

“At this critical point in the pandemic, we have the production capacity and supplies necessary to meet the testing needs for all of Canada,” underscores Whalen. “Our made-in-Canada solutions give laboratories, public health authorities and businesses across the country the ability to continue to respond to the COVID-19 pandemic without being beholden to international suppliers that may not see Canada as a priority market.”

As an added benefit, these instruments can run multiple sample types and test targets including environmental surveillance testing of surface or wastewater samples for the virus that causes COVID-19, both of which have been proven to help with early detection of potential outbreaks during the current pandemic.  Additionally, the same instruments can be used to target common water- and food-borne pathogens such as legionella, coliforms, algae, listeria, salmonella, and more through adaptable testing kits available from LuminUltra.

Since March of this year, LuminUltra has recognized the important role of testing in the fight against COVID-19 and has focused on increasing capacity to meet the testing needs of all of Canada. Underscoring its reliable supply chain, LuminUltra responded promptly to the Government of Canada’s testing needs earlier in the year and has been a key supplier of the isolation reagents for the national testing program since April, keeping up with the demand of national testing needs by providing 500,000 tests a week.

KIND Announces Acquisition of Better-for-You Snacking Company Nature’s Bakery

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KIND, a healthy snacking leader, announced it has entered an agreement to acquire Nature’s Bakery, a family-owned company that offers wholesome & delicious snacks, such as its beloved Fig Bars and other soft-baked foods. This partnership will extend Mars’ portfolio of businesses in the health & wellness space and build on KIND and Mars’ shared vision to build out a platform of brands and products that make wholesome snacking choices more readily available to people everywhere.

Founded in 2011, Nature’s Bakery was built on a promise to always deliver better-for-you snacks that taste as good as they make you feel. The company bakes its own bars with recipes that prioritize real, simple and wholesome ingredients like sun-ripened fruit and hearty whole grains to create snacks that are plant-based, nut-free, dairy-free, and 100% Non-GMO Project Verified. Nature’s Bakery’s soft-baked, nut-free favourites will be a differentiated and complementary offering to KIND’s existing portfolio, whose first ingredient is a nutritionally dense food such as whole nuts, whole grains or whole fruit. Together, the brands’ unique offerings will satisfy a broader range of nutritional needs, dietary restrictions, and taste preferences. This planned transaction advances KIND’s commitment to creating a foremost health & wellness platform as a separate business within Mars.

Source: www.prnewswire.com

Wellness Natural, Inc. Acquires SimplyProtein®

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Wellness Natural, Inc., a newly created natural foods company headquartered in Toronto, Canada announced today that it has acquired SimplyProtein®, a nutritional snacking brand previously owned by Simply Good Foods USA, Inc. With a presence throughout Canada and the U.S., SimplyProtein is poised to expand under the leadership of CEO Michael Lines, who led the brand in Canada prior to creating Wellness Natural, Inc.

With a premium nutritional profile including clean ingredients, plant-based protein, high fibre, and 0-3 grams of sugar, SimplyProtein products are gluten-free and Non-GMO Project Verified. With a robust variety of products marketed in Canada and a separate group of products marketed in the U.S., the SimplyProtein line includes a rich assortment of bars, cookies, chips, and crunchy bites, for both adults and children.

“I’ve had the pleasure of working on SimplyProtein throughout my tenure at Simply Good Foods, and developed a true passion for the brand and its positioning within the nutritional snacking space,” said Michael Lines, CEO, Wellness Natural, Inc. “With many of our products plant-based, SimplyProtein fills an essential consumer need, as it checks off all the boxes. With optimal protein, high fibre, low in calories and sugar with clean ingredients – it’s what consumers are looking for – while also being incredibly satisfying and delicious which is paramount. I’m eager to continue to grow the brand and excited about what the future holds for SimplyProtein. I’m also excited to chair an outstanding board of directors including John Lederer, Joe Mimran, Joe Jackman, Nicholas Reichenbach, and Steve Spooner.”

Loblaw Companies Limited – PC Health app

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Loblaw Companies Limited (TSX: L) (“Loblaw”) announced the Ontario launch of the PC Health app, a new health and wellness app powered by League, the country’s leading health operating system (health OS) technology provider. First launched in Atlantic Canada in October, the app is designed to empower Canadians with convenient access to healthcare resources and support – where and how they want it.  As of today, the app is now also available for download in Ontario, British Columbia and Alberta.  Loblaw plans to expand nationally over the coming months while also adding features and functionality to the PC Health experience to include services such as virtual physician care and digital pharmacy.

Ontarians can log on to the PC Health app to get health or nutrition guidance via live chat with a registered nurse or dietitian, see their personal health goals and work to meet them through daily activities outlined in a variety of health programs. Users can choose programs that are tailored to their own needs and interests, from maternal and family health or diet and nutrition programs, to mental health or anxiety management.  Users will also have the opportunity to earn PC Optimum™ points by completing daily goals and activities.

Loblaw has leveraged its extensive expertise in food and nutrition along with experience in healthcare and pharmacy gained through Shoppers Drug Mart Inc. to create what it believes to be a one-stop digital health tool for Canadians.  Owned by Loblaw, Shoppers Drug Mart is Canada’s number one provider of pharmacy products and services and together the companies are uniquely positioned to help Canadians navigate a complex healthcare system.

“Our company’s purpose is to help Canadians live life well and the PC Health app is an innovative and powerful new tool that we really think brings this to life,” said Jeff Leger, President, Shoppers Drug Mart.  “This app combines our company’s expertise – health and wellness advice, nutrition, and rewards – into a healthcare solution for Canadians that can live right at their fingertips.”

By completing a health profile on the app, each user receives personalized recommendations based on their own particular health needs or interests.  “Since launching in Atlantic Canada, we’ve had really great feedback from customers who are interacting with both the care teams and healthcare programs and have been excited by how helpful they are in meeting their specific needs,” said Leger. “Whether Canadians need help finding a local physician, want support with simple meal planning or are looking to better understand their sleep habits, the PC Health app has the tools to help them better manage their health and wellbeing.”

The app has a wide range of features including:

  • Care navigators who are available to help guide users through the complex health care landscape to help find the support they are looking for, whether that means a healthcare provider such as a dentist or family doctor, or a nearby medical facility that’s open late. Users can also connect for free to registered nurses and dietitians via virtual live chat to address pressing health and nutrition questions in real-time. And in the coming months, users will also have access to real-time virtual care from pharmacists, family physicians and specialists, directly on the app.
  • Free health programs built into the app that is designed to help users develop healthy habits by providing tips for living a healthier lifestyle. Educational content is combined with daily goals and simple lifestyle activities that, as they are completed, earn users PC Optimum™ points along the way.
  • A marketplace where users will find a curated online health and wellness shop filled with products and services to help them manage their health and wellbeing. Users can earn PC Optimum™ points on select products and services purchased through the app.

Loblaw partnered with the health-tech leader, League, to provide the technology and digital health expertise behind the app. League’s proven care delivery, personalization model and behavioural science knowledge were essential in the platform’s development and future scalability.

“We are excited to be working with Loblaw on this meaningful project,” said Michael Serbinis, Founder & CEO, League. “The healthcare system is a complex web of information, providers, and insurers. The PC Health app will help address these issues and provide a new personalized “front door” to healthcare. Thousands of people already use League every day to manage their health and get support, we’re thrilled to now be able to help thousands more.”

The PC Health app is available now in Atlantic Canada, Ontario, British Columbia and Alberta in both English and French. Download it for free on the App Store or Google Play.

Jean Coutu Group

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The Jean Coutu Group announces that its unionized employees at the Varennes distribution centre, represented by the Syndicat des travailleuses et Travailleurs de PJC Entrepôt-CSN (STTPJC-CSN), have ratified their new collective agreement at 78%, thus ending the current labour dispute.

“This 5-year agreement allows us to meet the needs of our employees, our pharmacists owners and customers in a fair equitable manner in an extremely competitive environment,” said Alain Champagne, President, Jean Coutu Group.

Operations will gradually resume as of Sunday, November 15, 2020.

European Parliament votes on plant-based food labels

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The European Parliament voted on proposed amendments to the Common Agricultural Policy (CAP) which would affect how plant-based products can be labelled in the EU.

MEPs voted against the so-called ‘veggie burger ban’, which would ban the use of meat-related terms, such as “burger” and “steak”, for plant-based products. However, they voted to tighten restrictions on the labelling of plant-based dairy alternatives which would prevent the use of dairy descriptors, such as “yogurt-style” or “cheese-alternative”, for non-dairy products.

The popularity of plant-based products has risen sharply in the last few years as consumers are becoming more conscious about the health impact and carbon footprint of the meat and dairy products they consume. A recent report by ING has found that European retail sales of meat and dairy alternatives have grown by almost 10% per year between 2010 and 2020 and it is estimated that the plant-based alternatives food market will be worth €7.5 billion by 2025. Last month’s vote by the European Parliament on the labelling of plant-based products is therefore timely. For plant-based producers, the vote raises two key issues:

1. Ban on the use of meat-related terms

The Committee on Agriculture and Rural Development proposed an amendment (no.165) to restrict the use of meat-related terms, such as “burger”, “sausage” and “steak”, to meat products only. The upshot of this being that plant-based products would no longer be able to use meat-related labels – for example, a veggie burger could no longer be labelled as a “burger” (instead there was some suggestion that it should be called a “veggie disc”).

The rationale for the proposed ban, particularly by meat lobbyists, was that use of meat denominations for non-meat products would risk confusing consumers and that use of such terms amounts to a “cultural hijacking” of the meat industry. Opponents of the ban have disputed that there would be any significant risk of consumer confusion and have said that it would directly cut across the European Green Deal (which aims to make Europe carbon-neutral by 2050) by making it harder for consumers to choose sustainable food products. Ultimately MEPs did not agree with the meat lobby and voted against the ban (by a vote of 379 to 284).

Interestingly, however, at a national level rules on meat-related labels are not consistent across Europe with some countries separately introducing their own bans. On 27 May 2020, the French National Assembly gave the final green light to a law that would prohibit the use of names commonly associated with animal foodstuffs for labelling and marketing products containing plant-based proteins. Producers of plant-based products will therefore need to carefully consider local laws on food labelling when exporting across the EU. It is also not clear how any such restrictions might apply to ‘alternative meats’ such as lab-grown meat developed from animal cells (watch out for our upcoming article on alternative meats soon!).

2. Ban on use of diary descriptors

The European Parliament has voted in favour of an amendment (no.171) which would place further restrictions on the use of dairy food labels for plant-based products. The use of dairy terms, such as “cheese”, “yogurt” and “milk”, for non-dairy products is already banned within the EU, following a decision by the CJEU in 2017, however, under the new amendment, these restrictions would go one step further by also prohibiting terms that liken plant-based products to dairy, eg “yogurt-style”, “butter alternative” or “cheese substitute”.

The European Parliament’s vote to ban the use of dairy descriptors remains subject to the decision of the Council, however, if the amendment is adopted, producers of plant-based dairy alternatives in the EU will have to think carefully about how to label their products going forwards and avoid any dairy descriptors. Producers will also need to review their existing product lines to identify and remove any such descriptors that may fall foul of the restrictions. In practice, given the earlier ban in 2017, producers may find that many of their products are already compliant and will not require further change.

Interestingly, if the regulation is not adopted before the end of the transition period on 31 December 2020, it will not be directly effective in the UK and, therefore, the restrictions will not apply in the UK (they will, of course, still apply to UK producers exporting to the EU). This could result in a situation where the labelling rules for non-dairy products are tighter in the EU than in the UK. Producers will therefore need to consider how this might impact their labelling/packaging strategies – for example, whether to diverge for different markets or maintain a consistent approach across both the EU and the UK. Ultimately, this is likely to be a question of potential benefit versus cost (and inevitable logistical difficulties!).

Whatever the outcome from the Council (and we will report back in due course), one thing seems certain – given the growing global demand for plant-based products the category is likely to continue thriving no matter what labelling restrictions are imposed.

Eat Beyond, supporter of innovation in plant-based & alternative foods, appoints new Chair

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Eat Beyond Global Holdings, an investment issuer focused on innovation in the global plant-based and alternative food sector, is pleased to announce that Don Robinson, who previously joined the Company to serve on the board of directors, and previously served as CEO of Mars Canada, has been appointed to Chair of the Board.

At Mars Canada, he transformed the business from an unprofitable operation losing $20M annually to a business with $25M in profit, with annual sales in excess of $500M.

“Eat Beyond stood out as the perfect opportunity for me to put my decades of experience to use for a movement I personally feel so passionate about. I myself went vegan about a year and a half ago, and it has had innumerable benefits for me. I believe that we will see the trend toward plant-based eating continue to grow, the environment and our collective health depend on it,” said Mr. Robinson. “This is why I am so personally excited about working with the team on identifying the next generation of great products and innovations that will move us toward a healthier and more sustainable future. (https://flixtor2.to) ”

Mr. Robinson’s experience spans three decades and four continents and includes leadership roles with industry giants including Mars Inc., Mars Canada, CARA Operations Ltd., and Kraft/Nabisco. Most recently, he served as Chairman, CEO and President of CARA Operations Ltd. (2006-2013), where he was responsible for successfully leading a $1.8B business with an EBITDA of $70M for a period of 7 years, this included 700 restaurants, 35,000 people and 5 restaurant chains.

“Mr. Robinson has brought tremendous value to the team as we have continued to scout and assess hundreds of companies in the global, plant-based, and alternative food sector,” said Patrick Morris, CEO of Eat Beyond. “We are very excited that Don has agreed to be our chairman of the board. His leadership and operational experience are key. We are not just providing capital to our portfolio companies, we are actively involved in the companies to help them scale and grow effectively.”

Mr. Robinson is also the Chairman of the Confectionery Manufacturers Association of Canada and is the Executive Vice-Chair of the Food and Consumer Products Association of Canada.

Source: Food In Canada

Mother Raw Raises $6.1 Million in Series A Funding to Encourage Everyone Everywhere to Eat More Plants

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Toronto based  Mother Raw, the line of fresh, consciously crafted and delicious plant-powered dressings, marinades, dips, condiments and quesos, announced today the closing of their $6.1M USD Series A financing round. The round of funding is led by new investor Forage Capital Partners, alongside Export Development Canada (EDC) and with substantial support from existing investor Whitecap Venture Partners. The new capital will help further propel rapid growth of Mother Raw across North America, well-timed with the massive growth in the plant-based foods sector and booming consumer demand. The brand plans to expand its distribution footprint, increase R&D efforts for new product innovation, and amplify marketing and sales initiatives.

Building on the initial Canadian-based start-up and following a significant rebranding and reformulation effort led by Mother Raw CEO Kristi Knowles, the brand has achieved an impressive market presence and is now in approximately 3,700+ stores across North America. Sales for Mother Raw have grown 247% from 2019 – 2020 and they have secured over 1,600 new retailers in the U.S. including Meijer, Pavilions, Sprouts, Target, Walmart Canada, Whole Foods and more, even during the pandemic. Since the initial launch of Mother Raw in early 2019, the brand’s growth is rooted in their commitment to organic plant-based ingredients, the agility of self-manufacturing, prominent placement in the growing refrigerated segment, delicious product variety and an accomplished and tenacious team.

Despite the obvious business duress of 2020, Mother Raw flexed their scrappy start-up muscles, rising up to navigate challenges ranging from manufacturing continuity, cancelled consumer and trade events, retailer disruptions and changes to shelf reset timing. The added funding further enables the brand to continue to advance its mission to “Put Good on GoodTM” by encouraging everyone everywhere to eat more plants, while elevating the plant-based eating category to new heights with their delicious, versatile and convenient offerings.

“The Mother Raw team remains steadfast in our focus to delight our consumers, retailers and suppliers as we advance our mission and business to make consciously crafted plant-based foods that deliver on taste,” said Mother Raw CEO Kristi Knowles. “Now with added partners on board, Mother Raw is excited about the future ahead with investment partners who wholeheartedly believe in our mission, are a strategic fit and possess expertise and knowledge to complement our business.  I’m confident our combined efforts and timely boost to the business will bring even greater success.”

“We were thoroughly impressed by the depth and accomplishments of the Mother Raw management team and their plans for the future, even more so during this very challenging time for most businesses,” said Jim Taylor, Partner at Forage Capital Partners. “We’re delighted to invest in Mother Raw during a critical time in the company’s development and are looking forward to being a part of their continued success.”

Mother Raw‘s impressive growth is attributed to its focus on innovation and quality products that meet the demand of a growing industry,” said Carl Burlock, Executive Vice-President and Chief Business Officer at EDC. “We are pleased to support Mother Raw through EDC’s investment Matching Program which will enable the company to increase investment in business development and innovation efforts, helping it execute on its ambitious growth plans across North America.”

The first investors behind Mother Raw, Whitecap Venture Partners, who have supported its growth since inception, have once again invested and are looking forward to what the future holds. “The team at Mother Raw is building a leading plant-based food brand and we are proud to continue our partnership with the company,” said Russell Samuels, Partner at Whitecap Venture Partners. “Having watched the business develop since 2016, we have never been more excited about the opportunity. We are excited to welcome both Forage and EDC to the Mother Raw team.”