As the marijuana market diminishes, Canadian entities are focusing on selling medical marijuana to patients whose employers provide MMJ health benefits. Alberta’s Aurora Cannabis and other market players have taken up a benefits-focused clinical strategy even as prices fall in the country’s broken-down, aggressive adult-use marijuana market.

But the uptake of medical cannabis benefit coverage is low. Prior to adult-use legalization, analysts expected the coverage would be a great area for self-insured benefits plans. That didn’t manifest as expected because few have adopted the coverage. This coverage has two types — the self-insured and the fully insured — says Mike Sullivan, an employee of Cubic Health, an employee consultancy firm.

The benefit-focused strategy seeks an avenue for higher-margin growth in this maturing market. However, cannabis entities say serving benefit-covered patients comes with high costs for education, research and customer relations.

Aurora Cannabis, which commands a 24% stake in the market, has channeled its business toward medical marijuana citing reliance on insured customers whose benefits cover MMJ. This has accounted for 80% of the company’s $17.2 million revenue in its first quarter. Those in an insured program buy more often and stay on similar medication for longer as opposed to the noninsured customers. Additionally, medical marijuana generates twice the profit of recreational marijuana in sales.

Aqualitas, a Nova Scotia cannabis producer. also said about 75% of its sales is from insured clientele. Ontario’s Entourage Health also records 90% of its revenue from insured clients bringing in $2.3 million in the recent financial quarter. Entourage absorbs the cost of consumer education, call centers and physicians, which in the process affects its margins.

Entourage Health CEO George Scorsis says the company’s margins on medical marijuana are not higher than for adult use. The profit is affected by the daily running of the business in terms of clinical work, product development, etc.

The Canadian medical cannabis market stood at $68.5 million by the third quarter of 2022 denoting that it runs into $274 million yearly. Veterans from the military are the largest beneficiaries of the benefit-covered medical marijuana project, spending $143.7 million of cannabis reimbursements in the 2022–2023 financial year.

Ned Pojskic, vice president of Green Shield Canada, the fourth-largest benefits company in the country, says prior interest in benefits coverage of medical marijuana failed to capture broad interest. Human resource leaders have been focusing on drug costs and the COVID-19 pandemic in relation to sales, among other things. Benefits expert Sullivan said after the legalization of adult-use cannabis in 2018, Canadian companies lost focus on medical marijuana. Aurora’s Martin agrees with Pojskic that extensive research could increase the benefits acceptance of medical cannabis.

As more players such as India Globalization Capital Inc. (NYSE American: IGC) go a step further and develop approved cannabis-based pharmaceuticals, the medical insurance industry is likely to move faster along the path of covering medical marijuana for policyholders.

NOTE TO INVESTORS: The latest news and updates relating to India Globalization Capital Inc. (NYSE American: IGC) are available in the company’s newsroom at https://cnw.fm/IGC

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CNW420 spotlights the latest developments in the rapidly evolving cannabis industry through the release of two informative articles each business day. Our concise, informative content serves as a gateway for investors interested in the legalized cannabis sector and provides updates on how regulatory developments may impact financial markets. Articles are released each business day at 4:20 a.m. and 4:20 p.m. Eastern – our tribute to the time synonymous with cannabis culture. If marijuana and the burgeoning industry surrounding it are on your radar, CNW420 is for you! Check back daily to stay up-to-date on the latest milestones in the fast -changing world of cannabis.

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The FDA is seeking more data and evidence about the safety of cannabis derivatives while touting its progress to aid agencies at state level in exposing a company that sells Delta-8 THC chewables that have “damaging” after effects. The FDA has also been criticized recently due to lack of rules allowing hemp-derived products to be marketed as diet supplements. The agency insists on the need for more data and seeks support from the legislative arm of Congress.

In a data collection bid, the FDA published a fact-finding notice seeking information on the availability and capabilities of able small-business sources to research about product challenges (quality issues), fatal effects on users and misinformation sites based on real-world data to aid in filling up knowledge pockets on these products.

Hemp and the derivatives became legal through the 2018 Farm Bill, making accessibility and demand for their products skyrocket.

The agency seeks businesses that can create reports on cannabinoid discoveries in write-ups as well as webinars of collected data, giving permission to the FDA to share this with stakeholders.

With this information, the FDA can develop regulations for the cannabis market even though it’s currently “taking action” against some hemp enterprises-selling products with suspicious packaging or ingredients by serving warning letters. For example, regulators from Minnesota were tipped off by the FDA recently on consumer complaints about a product, leading to a lawsuit against the entity Northland Vapor, accusing it of breaching the state’s THC Edibles Act enacted in 2022.

The FDA and pharmaceutical board initiated a task force in November leading to 140,000 parcels of Delta-8 THC gummies and 2,300 syrups being confiscated. The products contained doses of THC above the permitted amounts. Regulators also noted that the products’ packaging could entice kids and the company failed to furnish the state with the necessary testing results.

To protect the public, the pharmacy board banned these products from circulation and asked the court to order the destruction of $7 million worth of illicit products and stop further production and sale of Northland Vapor brand products. Republican House members M. Griffith and B. Guthrie wrote to the FDA, calling out the agency’s continued slacking on the regulations for CBD. Griffith and others also penned yet another letter expressing annoyance over the FDA’s insufficient answer to their bill asking for permission for hemp-derived cannabis to be allowed as an additive to food.

Lawmakers insist that the FDA enforce its mandate in providing clarity and a pathway for CBD industry as opposed to just issuing warning letters to companies under suspicion.

The regulatory issues surrounding cannabis compounds are so complex that some companies seeking to develop medicinal formulations, such as India Globalization Capital Inc. (NYSE American: IGC), are much better off since their path to FDA approval is clearly known.

NOTE TO INVESTORS: The latest news and updates relating to India Globalization Capital Inc. (NYSE American: IGC) are available in the company’s newsroom at https://cnw.fm/IGC

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The U.S. Justice Department is seeking for more time from a federal court to answer a lawsuit over the legality of drug-use sites where individuals use illegal substances in a clinically approved environment. The institution at the center of this case, the Overdose Prevention Center, had initially allowed a request for prior delays in the case, but they did not agree to the latest scenario. They filed for an opposition motion instead.

This case has seen sustained delays in the past three years. The case was raised when the Department of Justice (under the Trump administration) denied a Philadelphia not-for-profit safehouse from initiating a harm-free facility.

In February, the Department of Justice was evaluating consumption sites that were supervised and was in discussion with the state as well as local leaders about worthy guardrails for the safehouses as an integral part of a holistic approach to the reduction of harm and the safety of the public.

The plaintiffs did not consent to this latest request by the justice department for more time and thus will be filing an opposition motion. In a statement, the safehouse said it believed there was progress when the justice department revealed that it had been evaluating its policies toward a controlled consumption service. The “appropriate guardrails” were meant to allow safehouses and other public health centers in the country to offer consumption services sans fear of criminal as well as civil enforcements from the federal department.

In Philly, four people overdose and die every day. A total of 1,276 fatal overdoses were documented last year alone, the highest on record. This is from a national statistic of drug overdose fatalities. The safehouse has been in litigation with the justice department since 2019 in an effort to flag off overdose prevention centers that have controlled drug consumption. Such centers provide critical strides in treatment, housing and the necessary social services to the drug users.

The Department of Justice now seeks to file an amendment counterclaim for Declaratory and Injunctive Relief by February 2023. This translates to another delay in the U.S. District Court in Pennsylvania a day after the court- approved Sunday deadline, much to the chagrin of the safehouse. This case has been pending in court for more than four years.

Because of the 2019–2021 litigation delay by the justice department, more than 3,000 people have overdosed in Philadelphia. Projecting into 2022, there is an expected spike in the deaths to 5,000 people.

While the facility in Philadelphia is entangled in litigations, New York opened a maiden harm education center late last year with officials posting positive life-saving reviews.

The Congressional Research Service pointed at a discrepancy saying the justice department actively protested the controlled consumption sites during Trump’s government, but Biden’s administration hasn’t sought to enforce the CSA against such sites. A report was issued within days after NIDA director Nora D. Volkow diplomatically endorsed the concept of authorizing the sites for safe consumption. She argued that scientific evidence demonstrated that these facilities can, in fact, prevent overdose fatalities.

Rahul Gupta, a drug czar at the White House, recently mentioned that the current administration would review the broader drug policy’s harm reduction suggestions, which include authorization of controlled consumption sites. He even suggested possible decriminalization.

The American Medical Association published a study in July stating that newly opened facilities in New York have reduced drug overdose fatalities and have redirected people from using drugs in public because there are facilities provided for this. These facilities also offer adjuvant services for drug users.

This case about safe consumption sites provides yet another front on which the fight to end marijuana prohibition is being fought. Another front is the state-level legalization movement which has, in a way, seen companies such as India Globalization Capital Inc. (NYSE American: IGC) to open shop and research cannabis-based medication.

NOTE TO INVESTORS: The latest news and updates relating to India Globalization Capital Inc. (NYSE American: IGC) are available in the company’s newsroom at https://cnw.fm/IGC

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Last week, the Marijuana Enforcement Division in the state of Colorado announced that cannabis grown under a medical cultivation permit could be recategorized as retail products and sold in adult-use shops. The division, which is tasked with the licensing and regulation of medical and retail cannabis industries in the state, also announced new safety protections for employees involved in the manufacture of marijuana. Workers who take part in a range of manufacturing tasks will now be required to wear goggles and masks as well as respirators.

Other announcements included the news that the eligibility period for would-be social equity licensees would also be extended from one to two years, which would afford equity applicants more time to navigate the licensing process once they were determined to be eligible.

In a news release, the division also announced that a report on intoxicating hemp products would be presented to the state legislature on Jan. 1, 2023. Intoxicating hemp products include delta-9 THC derived from hemp, which is a potent cannabinoid that induces a high when consumed. The agency also announced that business owners could also easily shift marijuana from one license type to another, which would significantly simplify business operations.

Currently, data from the state shows that it has 789 licensed cultivators of recreational cannabis and 431 licensed cultivators of medical cannabis, with some businesses holding both license types. With regard to retail outlets, the state of Colorado has 669 licensed recreational shops and 399 licensed medical dispensaries.

Observers of the burgeoning cannabis industry estimate that the total number of physical stores surpasses 700.

Licensees that hold both adult-use and medical permits to cultivate marijuana will also be allowed to change between medical cannabis to retail, on the condition that both permits have one or more common owners. This is stipulated in a measure that was recently signed by Governor Jared Polis.

The Marijuana Enforcement Division also announced that beginning Jan. 1, 2024, marijuana flower and pre-rolls sold in the state need to be labeled with a use-by date. These products will also need to be packaged with proper instructions on how they should be stored.

In addition to this, licensees have been ordered to carry out testing on shelf stability to determine appropriate sell-by dates for their products. Marijuana that isn’t tested will have a nine-month shelf life. However, the agency notes that marijuana can still be sold even after it passes its use-by date, as long as the buyer is aware of it.

Many companies such as India Globalization Capital Inc. (NYSE American: IGC) are going a step further to develop therapeutic formulations based on cannabis compounds so that these products secure FDA approval and are available for prescription.

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CNW420 spotlights the latest developments in the rapidly evolving cannabis industry through the release of two informative articles each business day. Our concise, informative content serves as a gateway for investors interested in the legalized cannabis sector and provides updates on how regulatory developments may impact financial markets. Articles are released each business day at 4:20 a.m. and 4:20 p.m. Eastern – our tribute to the time synonymous with cannabis culture. If marijuana and the burgeoning industry surrounding it are on your radar, CNW420 is for you! Check back daily to stay up-to-date on the latest milestones in the fast -changing world of cannabis.

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New research has found that the legalization of medical cannabis has been linked to a reduction in the use and prescription of opioids for patients with cancer. The research involved a cross-section analysis of data on insurance claims from more than 38,000 individuals who had recently been diagnosed with cancer.

The analysis included 34 states and was carried out by researchers at the University of Texas, Harvard University, Albert Einstein College of Medicine and Weill Medical College of Cornell University. The researchers’ objective was to examine how the existence of more cannabis dispensaries influenced opioid prescription.

Researchers discovered that medical marijuana legalization implemented in the period between 2012 and 2017 was associated with a 5.5% to 19.2 % relative reduction in the rate at which opioids were dispensed. The researchers stated that medical cannabis could be serving as an opioid drug substitute among some patients who were undergoing treatment for cancer.

This results come after the scientists discovered that, in general, the legalization of medical cannabis with dispensary allowances was linked to a higher decrease in the rate of one or more opioid days, especially for individuals who had recently received breast cancer diagnoses. They also discovered that the legalization of medical marijuana was linked to a decrease in pain-related hospital events among patients suffering from lung cancer and, to a lesser extent, breast cancer patients. The researchers noted that such decreases were observed soon after medical cannabis legalization came into effect.

In their report, the investigators theorized that some mechanisms could help explain their observations. For instance, they hypothesized that having legal access to medical cannabis may have prompted oncologists to prescribe less opioids. They also wrote that medical cannabis legalization may also have been linked to a decrease in the demand for opioids by patients who used cannabis to manage their pain as well as patients who used cannabis as an alternative to the pharmaceutical drugs.

In their conclusion, the investigators noted that more research was needed to shed light on the nature of these links and implications for patient outcomes. This is in addition to highlighting some of the limitations the study faced.

The study’s findings were reported in the “JAMA Oncology” journal. The results largely align with prior research on prescription trends and state-level marijuana reform. For instance, a separate study also found that allowing legal access to medical marijuana enabled patients to decrease their use of opioid painkillers or stop using them completely.

Many companies, such as India Globalization Capital Inc. (NYSE American: IGC), are developing cannabinoid-based formulations focused on alleviating chronic pain, so the number of cancer patients using opioids is likely to drop even further once these novel drugs become available.

NOTE TO INVESTORS: The latest news and updates relating to India Globalization Capital Inc. (NYSE American: IGC) are available in the company’s newsroom at https://cnw.fm/IGC

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India Globalization Capital (NYSE American: IGC) applauds the signing of the Medical Marijuana and Cannabidiol Research Expansion Act, which was signed into law by President Biden on Friday Dec. 2, 2022. The legislation establishes a new registration process for conducting research on marijuana and for manufacturing marijuana products for research purposes and drug development. “The study and development of cannabis for its potential therapeutic benefits is at the center of our work at IGC-Pharma,” said Ram Mukunda, CEO of IGC. “For many years, onerous federal barriers have made it difficult to efficiently source and study cannabis for pharmaceutical applications. We believe the establishment of this new law, which hastens the research application process and also ensures adequate supplies of marijuana for clinical studies, is a milestone development for the medical cannabis industry at large and a very positive development for our company.”

To view the full press release, visit https://cnw.fm/66Dlz

About India Globalization Capital Inc.

India Globalization Capital develops advanced cannabinoid-based formulations for treating diseases, including but not limited to Alzheimer’s, Parkinson’s, chronic pain, and pet seizures. The company’s leading drug candidate, IGC-AD1, has demonstrated, in Alzheimer’s cell lines, the potential to be effective in suppressing or ameliorating a key protein responsible for Aβ plaques and has recently entered phase 2 clinical trials for agitation in dementia from Alzheimer’s. The company also has lines of various CBD-based consumer products such as Holief, which includes gummies and pain relief creams for women experiencing premenstrual syndrome (“PMS”) and dysmenorrhea (period cramps), and Sunday Seltzer, which includes a CBD-infused energy beverage – all currently available for purchase. The company also operates an infrastructure business based in India. The company is headquartered in Maryland, U.S.A.

NOTE TO INVESTORS: The latest news and updates relating to IGC are available in the company’s newsroom at https://ibn.fm/IGC

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• IGC’s leading drug candidate, IGC-AD1, has completed Phase 1 of a safety and tolerability trial and entered Phase 2 trials for treating agitation in patients with Alzheimer’s dementia
• As of September 2022, the IGC trial is the only ongoing Phase 2 trial of a natural THC based formulation on Alzheimer’s patients
• The company’s other drug candidate, TGR-63, is an enzyme inhibitor that has shown in preclinical trials the potential to reduce neurotoxicity in Alzheimer’s cell lines
• Alzheimer’s disease impacts over 55 million people worldwide and about 5.5 million individuals in the U.S.

India Globalization Capital (NYSE American: IGC), through subsidiary IGC Pharma, develops, patents, and markets advanced THC-based drug formulations for the treatment of symptoms related to various diseases including but not limited to Alzheimer’s disease, Tourette syndrome, chronic pain, and pet seizures.

IGC’s leading drug candidate, IGC-AD1, has completed Phase 1 of a safety and tolerability trial and entered Phase 2 trials for treating agitation in patients with Alzheimer’s dementia, the first study in humans of a natural tetrahydrocannabinol (“THC”) compound plus another molecule (www.clinicaltrials.gov). As of September 2022, the IGC trial is the only ongoing Phase 2 trial of a natural THC-based formulation on Alzheimer’s patients.

The company’s other drug candidate, TGR-63, is an enzyme inhibitor that has shown in preclinical trials the potential to reduce neurotoxicity in Alzheimer’s cell lines. Both drug candidates have shown their ability to ameliorate beta amyloid plaques in Alzheimer’s cell lines and improve memory in Alzheimer’s mouse models. Beta amyloid plaques are a key hallmark of Alzheimer’s and an important target of Alzheimer’s pharmaceutical drug development.

Neuro Psychiatric Symptoms (“NPS”) are not only debilitating for Alzheimer’s patients; they also place an immense emotional burden on their caregivers. Beyond reducing symptoms, IGC-AD1’s active molecules and TGR-63 have also shown promise in preclinical trials to reduce important hallmarks of Alzheimer’s including plaques and tangles, as well as improving the treatment of memory loss.

Over the past eight years, the IGC team has amassed a deep knowledge of cannabinoid science, including extraction, isolation, purification, and development. The company’s strategy is to leverage its unique end-to-end capabilities, platform, and expertise to develop a class-leading program and bring it to market quickly and cost efficiently to treat neurodegenerative diseases such as Alzheimer’s.

The company also has a family of cannabidiol (“CBD”)-based consumer products (www.Holief.com) such as pain relief creams, pain relief gels, purpose gummies, tinctures, and capsules targeting women’s wellness, with a particular focus on premenstrual syndrome (“PMS”) and dysmenorrhea (period cramps). In addition, the company targets individuals that need sleep-aids with its specially formulated low melatonin cannabinoid gummies.

IGC has also introduced a low-calorie CBD- and caffeine-infused energy beverage brand (www.SundaySeltzer.com) that is currently available for purchase. The company’s brands are founded on the belief that effective natural solutions should be affordable and accessible to everyone. As the demand for natural products targeting women’s wellness and energy drinks continue to grow, these products are seeing strong traction in the market.

The company operates three facilities – a large GMP (Good Manufacturing Production Standards) certified facility that includes extraction, distillation, and manufacturing, in Washington State; a GMP-211 (pharmaceutical) grade facility in Maryland; and a facility licensed for controlled substances including cannabis in Bogota, Colombia, with complete access to legal licensed cannabis where the company conducts its testing.

In addition, the company’s development under Magistral Formulations is approved by INVIMA (Colombia National Food and Drug Surveillance Institute) to treat neurological disorders, non-oncological chronic pain, and mental disorders.

IGC’s intellectual property (“IP”) portfolio comprises of eight patents that it controls and seven patent applications. The portfolio includes #11,446,276, a patent for extreme low dose THC treatment of Alzheimer’s that was granted in September 2022.

The company is headquartered in Potomac, Maryland.

IGC-AD1

IGC-AD1 is the company’s leading drug candidate for the treatment and relief of Alzheimer’s symptoms. A significant amount of research on Alzheimer’s cell lines has shown that the active agents in IGC-AD1 reduce plaques and neurofibrillary tangles that are the hallmarks of Alzheimer’s. Further, micro-dosing of THC, as shown in cell lines, could increase the functioning of mitochondria and potentially promote the growth of new neural pathways (neurogenesis). The research shows that micro-dosing of THC affects the brain radically differently from the normal higher dosing of THC.

While there is a significant body of research showing that THC is neuro-toxic at normal levels of dosing, micro-dosing of THC has been shown to be non-toxic to neurons. With the results of these preclinical studies, the company developed an oral formulation, IGC-AD1. The company recently completed a safety and tolerability Phase 1 trial on Alzheimer’s patients and has initiated a Phase 2, multi-site, double-blind, randomized, placebo-controlled trial of the safety and efficacy of IGC-AD1 on agitation in participants with dementia due to Alzheimer’s disease at sites in the U.S. and Canada. IGC expects the Phase 2 trial to take between 9 and 12 months to complete, barring unknown factors such as, for example, a resurgence of COVID and the enforcement of lockdowns and travel restrictions.

With further successful trials and FDA approvals, IGC hopes to bring a drug based on natural THC as an effective treatment for agitation in Alzheimer’s to market.

TGR-63

The company’s other molecule, TGR-63, has been shown to reduce the neurotoxicity that impacts memory loss in preclinical trials with mice. On a dose dependent manner, transgenic Alzheimer’s mice treated with TGR-63 showed improvement in memory relative to control.

Both drug candidates, IGC-AD1 and TGR-63, have shown their ability to reduce the brain plaques associated with memory loss in Alzheimer’s in mice.

With further successful trials and FDA approvals, IGC hopes to bring TGR-63 as a treatment for Alzheimer’s disease to market.

Market Opportunity

Alzheimer’s disease impacts over 55 million people worldwide and about 5.5 million individuals in the U.S. Over 70% of these patients face debilitating symptoms, including anxiety, depression, and agitation (Mendez, 2021). Agitation in dementia patients can include excessive physical movement and verbal activity, restlessness, pacing, belligerence, aggression, screaming, crying, and wandering.

In 2020, the estimated healthcare costs for Alzheimer’s disease in the U.S. were $305 billion. Medicare and Medicaid covered about 70% of those costs, leaving considerable burden on patients and families. At the current rate of growth of Alzheimer’s and other dementia diagnoses, those costs are estimated to reach over $1 trillion by 2050.

Currently, there are no FDA-approved medications to alleviate the symptoms of dementia due to Alzheimer’s disease, providing a tremendous opportunity for formulations that can have an impact on quality of life and disease progression.

Management Team

Richard Prins has been chairman at IGC since 2012 and served as an independent director since 2007. From March 1996 to 2008, he was the Director of Investment Banking at Ferris, Baker Watts, Incorporated. Prins served in a consulting role to RBC until January 2009. He currently volunteers full time with a non-profit organization, Advancing Native Missions, and is a private investor. Since February 2003, he has been on the board of Amphastar Pharmaceuticals Inc. He holds a bachelor’s degree from Colgate University and an MBA from Oral Roberts University.

Ram Mukunda is CEO and President of IGC. He has been the chief inventor and architect of most of the company’s patent filings and is responsible for the company’s strategic positioning. Prior to IGC, he was founder and CEO of Startec Global Communications, which he took public in 1997. He served as Strategic Planning Advisor at Intelsat, a communications satellite services provider. From 2001 to 2003, he was a Council Member at Harvard’s Kennedy School of Government, Belfer Center of Science and International Affairs. He was named the 1998 Ernst & Young Entrepreneur of the Year. He holds bachelor’s degrees in electrical engineering and mathematics, and a master’s degree in engineering from the University of Maryland.

Dr. Jagadeesh Rao is the company’s Principal Scientist. His career spans two decades in the public sector and product R&D for Johnson & Johnson. He leads IGC’s scientists in the development of pharmaceutical and OTC products. He worked for the federal National Institutes of Health, and for the National Institute on Drug Abuse. His Ph.D. in Neurochemistry is from the National Institute of Mental Health & Neurosciences in India. He did postdoctoral training at the University of Illinois-Chicago.

Claudia Grimaldi is a Director, Vice President, Principal Financial Officer, and Chief Compliance Officer for IGC. She also serves as a Director/Manager Director for some of the company’s subsidiaries. She graduated with highest honors from Javeriana University in Colombia with a bachelor’s degree in psychology. She holds an MBA, graduating with highest honors, from Meredith College in North Carolina. In addition, she has attended the Darden School of Business Financial Management Executives program and the Corporate Governance Program at Columbia Business School. She is currently pursuing her Directorship Certification with the National Association of Corporate Directors. She is fluent in both English and Spanish.

For more information, visit the company’s website at https://igcinc.us/.

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