On December 2, Tetra Bio-Pharma (TBP) (TBPMF) announced an agreement with Alternavida S.A. de C.V. for the co-development and commercialization of CAUMZ in Mexico. According to the company’s investor presentation, CAUMZ is a cannabinoid-derived therapeutic comprising pure synthetic THC and CBD.
The company is studying CAUMZ as an alternative for opioids for advanced cancer pain in an ongoing pivotal trial, SERENITY. The company is also studying CAUMZ in another Phase 2 trial, REBORN, for breakthrough pain in cancer patients. Tetra Bio-Pharma has also planned to study CAUMZ in fibromyalgia indication. The company anticipates regulatory approvals in the US. and Canada by late 2020.
According to the press release, Alternavida would be responsible for fully funding two clinical trial sites in Mexico for the SERENITY research program and planned fibromyalgia trial. These clinical trial sites should be mostly operational by early 2020.
Alternavida would also be responsible for securing regulatory approvals and commercializing the therapy in Mexico. Plus, the company has the right of first refusal in an additional eight countries. In return, Tetra Bio-Pharma would earn a one-time license fee of 125,000 Canadian dollars. The company would also receive royalties on CAUMZ’s Mexico sales.
Mexico’s drug cartels are aggravating the opioid epidemic
On November 5, as reported by Reuters, DEA (U.S. Drug Enforcement Administration) cautioned against Mexican drug cartels producing enormous quantities of fake prescription pills containing the synthetic opioid fentanyl. These are intended to be distributed in North America.
As reported by NPR, Mexico accounts for more than 90% of the lethal drugs sold in the US. As reported by Newswise, homicides in Mexico, many of which were associated with drug cartels, reached 36,000.
CAUMZ’s target market: Chronic pain
According to the company’s investor presentation, CAUMZ is targeting a worldwide addressable market of 11.1 billion Canadian dollars for chronic pain. The company has formulated CAUMZ as a THC–CBD (9.5%–2.5%) combination, with less than 4% capsule-to-capsule variability. The Mighty Medic vaporizer would deliver the drug.
According to Grand View Research, as reported by MarketWatch, Mexico’s medical cannabis market could grow at a CAGR (compound average growth rate) of 27.7% from $47.3 million in 2018 to $249.6 million in 2025. Increasing adoption for chronic conditions such as chronic pain, Alzheimer’s, epilepsy, arthritis, and anxiety could be key growth drivers for this market. However, similar to that seen in 2018, Grand View Research expects chronic pain to be the biggest revenue driver in Mexico’s medical marijuana market.
Other cannabis players are also targeting the chronic pain segment
According to Khiron Life Sciences’ (KHRN) (KHRNF) investor presentation, there are 68 million potential medical marijuana patients in Latin America. Chronic pain accounts for almost 52.5% of the total patient pool.
Euromonitor 2018 and Prohibition Partners Latam Report 2017 estimated the size of Mexico’s medical cannabis market to be $1.33 billion in 2028. The size of the medical marijuana market in Columbia and Chile could reach $444 million and $3.35 billion, respectively. The size of this market in Brazil and Peru could be $229 million and $99 million, respectively.
On November 19, Khiron Life Sciences announced that it became the exclusive Latin American provider of medical marijuana for Europe’s largest medical cannabis study, Twenty21. This study aims to evaluate the efficacy and safety of medical cannabis in 20,000 patients. The study would cover indications such as epilepsy, chronic pain, post-traumatic stress disorder, and multiple sclerosis.