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Interest in medical cannabis is growing worldwide, resulting in many countries legalising cannabis for medical use. In particular, the South American market is progressing rapidly and has become a focus for biotech companies seeking to gain a foothold in the global medicinal cannabis market. Consumer perceptions are shifting, with recent studies showing 70% of South Americans agree with the use of medical cannabis and 51% are in favour of legalising cannabis9. However, legislation is still catching up as only six countries in South America have legalised cannabis for medical or recreational use – these are: Argentina, Brazil, Chile, Colombia, Paraguay and Uruguay1. LEGALISATION IN SOUTH AMERICA Argentina – as of March 2017, Argentina has legalised cannabis oil for the treatment of serious medical conditions2. This new law permits the cultivation of cannabis for distribution and research2. The Argentinean government also provides a medical cannabis research program that guarantees free access to cannabis oil to patients who join the program12. Brazil - has the largest population of any country in South America and has partially legalised cannabis use11. To date, the government has decriminalised the possession of small amounts of cannabis1. However, support for cannabis use is growing as in March 2017, the health department of Brazil approved the country’s first-ever license to sell a cannabis-based medical product, Mevatyl (also known as Sativex)3 which is a mouth spray for multiple sclerosis patients2. Colombia - has legalised cannabis for medical use1. This move was made in the hope of diminishing Colombia’s drug trafficking business13. As part of its peace process with the Revolutionary Armed Forces of Colombia (FARC), Colombia also plans to offer a crop substitution program for farmers of illegal coca crops to cultivate cannabis legally instead1. Paraguay – main source of cannabis for Brazil, Argentina, Uruguay and Chile16. However, since 1988, cannabis use is only partially legalised permitting possession of 10 grams or less for personal consumption16. In May 2016, Real Scientific Hemp Oil™ became the first medical cannabis product authorised by Paraguay’s government as a prescription medication for refractory epilepsy7. Uruguay – in 2013, Uruguay became the first country in the world to legalise cannabis consumption (for medical and recreational use), along with its sale and cultivation at the Federal level1,8. Starting in 2017, recreational users and medical patients are able to purchase up to 40 grams of marijuana a month from their local pharmacist or they can opt to grow it at home1. The Uruguayan government has allowed 16 drugstore chains to sell cannabis at US$1.30 per gram but this will only be available to Uruguayan citizens or permanent residents5. Chile – in 2015 medical cannabis was legalised, with South America’s first and largest medical cannabis farm established the following year, just 170 miles south of Santiago in Maule9,10. This was officially inaugurated by Foundation Daya, a non-profit organisation that advocates for the legal use of medical cannabis6. The Foundation has a permit issued by the Chilean government to grow medical cannabis6. The farm’s harvest will be distributed to about 4,000 patients throughout Chile6. Recently, the Chilean Congress made cannabis available in Santiago pharmacies10. The Chilean Congress is also progressing with a Bill that that would allow the possession of up to 10 grams of cannabis and the growing of up to 6 plants14. South America’s growing demand and acceptance for medical cannabis makes it an ideal hub for budding companies to establish a base – Zelda Therapeutics is one company that has done this. The company has established strong partnerships in Chile to facilitate its medical cannabis research programme. Chile is an ideal place for Zelda’s research, as Chile’s legal framework recognises the importance of medical cannabis research and allows the production of medical cannabis under strict regulatory controls for the treatment of medical conditions. Chile is also Australia’s 3rd largest trading partner in South America and provides a cost-effective location for Zelda Therapeutics to conduct clinical trials. ZELDA THERAPEUTICS (ASX: ZLD) Zelda Therapeutics (‘Zelda’) is an Australian-based bio- pharmaceutical company that has secured exclusive, global access to an extensive set of human data related to medical cannabis based formulations and treatment protocols. Currently Zelda has pre-clinical research in breast cancer, brain cancer and pancreatic cancer and is undertaking clinical trials in insomnia, autism and eczema. The company has partnered with the world’s leading cancer cannabis researchers at Complutense University Madrid in Spain to conduct certain pre-clinical work testing cannabis-based formulations known to have an effect in humans. A similar programme is in place with the Australian Telethon Kids Institute targeting paediatric brain cancer and Curtin University targeting pancreatic cancer. The company has also established a significant part of its clinical research programme in Chile, to fast track the development of its formulations. ZELDA’S RELATIONSHIPS IN CHILE Zelda has established a strong and strategic foothold in Chile, undertaking clinical trials that focus on autism, eczema and insomnia. The company has leveraged its relationship with Australian cannabis company AusCann, working with AusCann’s Chilean joint-venture DayaCann - the only licensed producer of medicinal cannabis in Chile. Zelda has also partnered with Chilean non- profit patient advocate group, Foundation Daya – who have extensive experience over a number of years in using medical cannabis to treat patients diagnosed with autism. Zelda will leverage this patient data to develop robust clinical trials and conduct its research under rigorous and controlled clinical conditions, using medical cannabis formulations already known to have an effect in sufferers of autism. Knop Laboratories is a leading Chilean pharmaceutical manufacturing group, which Zelda has a strategic manufacturing and distribution agreement with. This forms an important part of the company’s Chilean activities, locking in a high quality supply of Zelda’s formulated medical-cannabis medicines initially, for its clinical trials, and subsequently a secure, scalable and GMP-grade source of commercial quantities following product registration. Knop is a trusted signature brand in Chile and also operates a chain of pharmacies throughout Chile, which could make them a key distribution channel for Zelda registered medicines following completion of its clinical trials. WHAT’S NEXT? Zelda is focused on using its global strategic partnerships to bring together experts in the medical cannabis field to clinically prove the benefits of medical cannabis and deliver new cannabis based therapies to patients in need. The company will continue discussions with Knop to manufacture its medical cannabis formulations, as well as discussions with potential distribution partners upon the formulations receiving registration approval. The registration in Chile also has the potential to open up further opportunities in other South American markets where medical cannabis is permitted, including the sizable Brazilian market. To learn more, or follow Zelda’s progress – visit the website: www.zeldatherapeutics.com Follow us on social media: Facebook: @ZeldaTherapeutics | Twitter: @ZLDTherapeutics | Linkedin: Zelda Therapeutics References 1. Americas Society/Council of the Americas 2017, Weekly chart: where does Latin America stand on Marijuana legalisation? Available from: http://www.as-coa.org/articles/weekly-chart-where-does-latin-america-stand-marijuana-legalization. [14 August 2017]. 2. Butterfield, D 2017, ‘Argentina just became the latest country to legalise cannabis oil’, HERB, blog post, 31 March. Available from: http://herb.co/2017/03/31/argentina-cannabis-oil/. [15 August 2017]. 3. Calabria, S 2017, ‘Brazil is the latest South American country to approve cannabis-based medicine’, HERB, blog post, 18 January. Available from: http://herb.co/2017/01/18/brazil-cannabis-based-medicine/. [14 August 2017]. 4. CNBC 2016, The next big billion-dollar cannabis markets investors are rushing to. Available from: https://www.cnbc.com/2016/10/21/the- next-big-billion-dollar-cannabis-markets-investors-are-rushing-to.html. [14 August 2017]. 5. CNBC 2017, Uruguay to be first country in world to sell cannabis in drug stores. Available from: https://www.cnbc.com/2017/04/07/uruguay-to-be-first-country-in-world-to-sell-cannabis-in-drug-stores.html. [14 August 2017]. 6. CNN 2016, Welcome to largest, legal marijuana field in Latin America. Available from: http://edition.cnn.com/2016/01/21/world/largest- legal-marijuana-field-inaugurated/index.html. [14 August 2017]. 7. Leafly 2016, Paraguay grants historic import permit to CBD hemp oil RSHO as medication for Epilepsy. Available from: https://www.leafly.com/news/politics/paraguay-grants-historic-import-permit-to-cbd-hemp-oil-rsho-as-me. [21 August 2017]. 8. McKay, T 2014, ‘One year after Uruguay legalised Marijuana. Here’s what it’s become’, Mic, blog post. Available from: https://mic.com/articles/106094/one-year-after-uruguay-legalized-marijuana-here-s-what-it-s-become#.ub8Lz0OAA. [21 August 2017]. 9. Roa, JL & Espinosa, SP 2016, ‘Medical marijuana and the green rush are changing Chile’, Merry Jane, blog post, 18 October. Available from: https://merryjane.com/culture/chile-cannabis-industry-green-rush-business.
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