Cannabis is medicine. As the use of medicinal cannabis becomes a fact of life in not only North America, but the world, it is now widely recognized that cannabinoids (the active ingredients in the cannabis plant) have numerous medicinal applications.
Many cannabis companies are producing dried flower and related products for use as medicine, and more and more often, these products are being officially prescribed by licensed physicians. This is greatly beneficial to the patients using medicinal cannabis as well as being profitable for cannabis companies.
How do investors see the profits from such cannabinoid medications increase? Through patent protection. The “Patent Cliff” is an operational and financial nightmare for the pharmaceutical industry. In 2017 alone; Big Pharma faced the loss of patent protection on licensed drugs with total revenues of $26.5 billion.
These multinational drug companies have never been hungrier for new patent-protected drugs, to replenish their drug pipelines – and their bottom lines. As drug development costs soar, more and more often Big Pharma is choosing to buy patent-protected drugs rather than meeting those development needs organically.
One Company that is looking to cash-in on the opportunities presented by the Patent Cliff is India Globalization Capital Inc. (NYSE Market: IGC, Forum). IGC describes itself as a “cannabis pharmaceutical company”, entering the cannabis space in 2013. On April 10, 2018, the Company announced the filing of its eighth U.S. patent application.
India Globalization Capital has pioneered the development of Hyalolex, a cannabinoid-based treatment aimed at alleviating many of the symptoms suffered by Alzheimer’s patients. A drug industry publication from October 2017 predicts sales of Alzheimer’s disease treatments to reach $14.8 billion by 2026.
Stockhouse recently had the opportunity to learn more about this latest development as well as India Globalization Capital’s overall operations from IGC’s CEO, Ram Mukunda.
Please introduce new investors to India Globalization Capital Inc.
We are listed on the NYSE American with the ticker “IGC”. Our structure consists of two lines of business: 1) a legacy International trading business with offices in India and 2) a medical cannabis business with offices in the U.S. We have developed a flagship product for alleviating many of the symptoms of Alzheimer’s known as Hyalolex. We believe that this product will bring relief to patients suffering from Alzheimer’s as well as reduce associated caregiver distress. The formulation is based on many years of research conducted at the University of South Florida and we expect to roll out this product to 10 U.S. states by the end of this year.
Let’s first dive right into your latest news: the filing of another patent in your pursuit for a cannabinoid treatment for Alzheimer’s disease. Precisely to what does this patent relate?
After years of research, we produced a liquid compound that contains a unique mix of natural products including THC at very specific dosing levels. Our patent filing seeks to protect the method of preparation and the composition of the formulation.
IGC’s lead cannabinoid pharmaceutical product is Hyalolex. Please explain what Hyalolex is and the time and effort that has been spent to date in developing this cannabinoid pharmaceutical product.
Producing this formulation took about seven years of research, and includes testing on Alzheimer’s cell lines, Alzheimer’s mice, and people. For example, one test involved measuring how long it would take regular mice to navigate a water maze. The results showed that it took mice with Alzheimer’s twice as long to navigate the maze as Alzheimer’s mice treated with the medication. Another study shows that one of the active ingredients in the formulation helped reduce plaque buildup in the brain. Plaques are considered to be a hallmark of Alzheimer’s.
The full background surrounding the research effort can be found on our website, www.hyalolex.com
Now please tell investors what Hyalolex does.
Alzheimer’s patients suffer from a variety of disorders and symptoms. For example, they suffer from plaque buildup in the brain, damage to mitochondrial functioning, neuronal death, loss of memory, anxiety, aggression, sleep disorder. And in general there is a lot of caregiver distress as the patient’s disease advances. Hyalolex helps alleviate these symptoms. For example, a patient suffering from Alzheimer’s may suffer from anxiety and sleep disorder, Hyalolex can help reduce anxiety and help them sleep better. It helps the patient and in turn helps caregivers.
As already mentioned, this is not the first U.S. patent that has been filed by the Company. What other patent applications have already been filed?
A full listing of our patents can be found on our website, www.igcpharma.com. In addition to Hyalolex, the Company has patent filings for Parkinson’s, which will be our next product. We also have a filing for Pain & Nausea, which we will introduce later this year as well as a filing for epilepsy in cats and dogs.
Could you tell investors what comes next for Hyalolex?
Hyalolex is a large market indication and we intend to commercialize this product in 2018 to bring much needed relief to this difficult diagnosis. It will be followed by Serosapse, which is going through testing and is for the benefit of patients suffering from Parkinson’s.
How, when, and where is IGC planning on rolling out this pharmaceutical product now that Hyalolex is protected by this patent application?
We plan to market Hyalolex in 10 states in the U.S. by the end of the year; our internal goal is to have 10,000 patients utilizing this therapy. So we have a 10-10 plan. Ten states, 10,000 patients on the therapy. Our tentative roll out plan is Puerto Rico, Maryland, Washington DC, New Jersey, Pennsylvania, California and the West Coast states. In addition we hope to have product available in Canada.
How else does this patent filing advance IGC’s operations?
The patent filing allows us to discuss the excipients and the formulation as well as present the data that we have on the efficacy of Hyalolex. It also protects us when we launch the product in other countries like Canada and Germany.
Investors want to make money, and Big Pharma is hungry for new patent-protected pharmaceuticals. What is the potential value of even one patent-protected pharmaceutical product in terms of an acquisition?
We have two plays forward: We expect to prepare Hyalolex for FDA trials. We hope to file an ANDA for Hyalolex with the FDA. If accepted this will allow us to take Hyalolex or a form of it to Phase 2 trials. An Alzheimer’s drug in Phase 2 trials has truly significant upside, drives shareholder value, and down the road is a potential acquisition for a pharmaceutical company.
Simultaneous with our FDA ambitions, we expect to distribute Hyalolex in medical dispensaries and hope to get 10,000 patients by the end of 2018. On an annualized basis achieving the 10,000-patient level equates to dispensary revenue between $14M and $20M with positive EPS for the Company. This is just a tiny share of the market. There are 5.5 million individuals suffering from Alzheimer’s in America and 44 million worldwide and we are talking about just 10,000 patients. Over the next few years as we get closer to 150,000 patients or 3% of the market the numbers get large and we could become a potential acquisition for a large supplement company.
The Company is also active in other research initiatives. Could you briefly discuss some of your other work?
We are working on Parkinson’s and the product is called Serosapse. Collaborating with IGC is a prestigious organization in California called The Parkinson’s Institute. Other initiatives in the pipeline include Pain, Nausea, and Depression.
Over the longer term, what is your vision for India Globalization Capital 24 months down the road?
Our vision is to become a leading pharma company that dominates two major disease states with products that improve the lives of patients suffering from both Alzheimer’s and Parkinson’s.
igcpharma.com
FULL DISCLOSURE: India Globalization Capital Inc. is a paid client of Stockhouse Publishing.