Although we are very favorable on the opportunity for licensed medical cannabis producers, we continue to believe that biotech firms will be the greatest beneficiaries of the legal cannabis movement.
One company focused on this opportunity is Tetra Bio-Pharma (TBP.CN: CSE) (TBPMF: OTCQB) and today, the company’s subsidiary submitted a report on the safety and pharmacokinetics of PPP001 to Health Canada.
Following this announcement, Tetra is also preparing for a Phase 3 clinical trial in collaboration with Québec’s leading medical cannabis clinic, Santé Cannabis. Tetra expects to launch the Phase 3 clinical trial by the fourth quarter of 2017 or first quarter of 2018.
PPP001 is the first smokeable cannabis drug product being developed for the treatment of late-stage cancer patients with pain. The Phase 3 clinical trial will be performed by Santé Cannabis’ medical team.
A Multi-Billion-Dollar Market Opportunity
This is a major milestone for Tetra Bio-Pharma and we expect the market to respond favorably to this news, especially after yesterday’s volatile trading day.
Cancer pain is a massive market and provides Tetra with a great opportunity to penetrate a multi-billion-dollar market opportunity. According to Global Pain Management, approximately 50% of cancer patients suffer from pain and more than 600,000 of these patients suffer from moderate-to-severe pain. In the United States, there are more than 4 million cancer patients and this pain market is valued at more than $5 billion.
After a detailed review of the clinical data, Tetra announced that the safety data met its expectations and that the pharmacokinetic data demonstrated that the inhalation of PPP001 achieved the targeted plasma levels of THC that could potentially achieve pain relief in cancer patients. The results of the Phase I trial provided the information required by Santé Cannabis’ medical experts to design a Phase 3 clinical trial for cancer patients.
Tetra will be completing the research required to ensure that PPP001 conforms to the chemistry and manufacturing requirements under the Food and Drug regulations to secure its Notice of Compliance and a Drug Identification Number.
In late May, Tetra had a pre-submission consultation meeting with the Therapeutic Products Directorate (TPD) of Health Canada to brief the agency on the safety findings and pharmacokinetics of PPP001, and to discuss its clinical development program leading to the submission of a New Drug Submission for a first indication in advanced cancer patients with pain. Health Canada provided feedback and guidance on Tetra’s clinical development program and the proposed Phase III clinical trial.
An Execution Story
Less than a month ago, Tetra signed a definitive agreement with Panag Pharma for the development and commercialization of novel cannabinoid based formulations for the treatment of pain and inflammation. Tetra is focused on generating revenue in 2017 by launching retail products via its partnership with Panag.
Panag has developed potential new cannabinoid-based therapies for ocular and topical anti-inflammatory and pain markets. The company also developed a cannabinoid topical drug product for the local treatment of pain and inflammation. Under the agreement, Tetra will have the exclusive right to sell the ocular and topical drug products in North America with right of first negotiation for international markets. Tetra will also have a right of first negotiation for future cannabinoid-based products.
Tetra will work with Panag’s team to ensure a rapid and successful process leading to marketing authorization. Panag will continue to develop new novel products for unmet medical need and Tetra will focus on commercializing these products.
A Differentiated Opportunity
We are favorable on this update and expect to see the shares move considerably higher today. Tetra has continued to execute on its strategy and is focused on creating value for its shareholders.
Tetra offers investors leverage to a company that is levered to the burgeoning legal cannabis industry through an opportunity that is different from what is currently available. This is a company in the early innings of a massive growth cycle and one that we think needs to be watched.
Disclaimer: Pursuant to an agreement between MAPH and Tetra Bio-Pharma, we were hired for a period of 90 days to publicly disseminate information about (TBPMF) including on the Website and other media including Facebook and Twitter. We are being paid $75,000 (CASH) for and were paid 250,000 restricted common shares of Tetra Bio-Pharma. We may buy or sell additional shares of (TBPMF) in the open market at any time, including before, during or after the Website and Information, provide public dissemination of favorable Information.
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