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Aphria (APHA) invested in Tetra Bio-Pharma (TBP, TBPMF) to diversify into the cannabis pharmaceutical industry. Not a bad move, although quick profits were not the norm for any R&D stage clinical trial based company. Patience was required. Together they developed a strategy to bring to market Tetra's PPP001, the first smoked cannabis as a prescription drug. The requirements were and are stringent for pharmaceutical grade cannabinoid drugs, including smoked cannabis. They developed PPP001, which Tetra named Qixleef, out of three different, complementary strains of cannabis grown by Aphria.

TBP has had Phase 1, Phase 2 and Phase 3 clinical trials running on Qixleef, the second currently running in the U.S.A. and the latter in Canada where the company stopped the Phase 3 to ensure the product was safe for patients by enhancing the processing & testing protocols further. Now Aprhia has upgraded its facilities to handle pharmaceutical grade cannabis for Tetra and the Phase 2 has in fact been using the product since its inception earlier this Summer. There will be a Phase 3 in the U.S.A. to complete that mission.

Last quarter Tetra hired Ms. Dania Scott from Canopy Growth Corporation (CGC) as Sr. Vice President, Commercial Strategy, working under Steeve Néron, Tetra's Chief Commercial Officer. According to Ms. Scott in a recent interview, "Qixleef is the first inhalation drug product that meets the U.S. CGMP regulatory requirements and is going through all the rigors of a regular pharmaceutical drug. When it commercializes globally, Qixleef will be the first-ever pharmaceutical-acting inhaled cannabinoid that has proprietary safety and dosage data; all the data will be proper to the Qixleef molecule itself and it's not class-related data. Qixleef has a fixed ratio of THC and CBD ... that the medical community and patients have been asking for."

Fast-forward to today's surprise announce that TBP has created a wholly-owned subsidiary business unit called "ENJOUCA". It was a well-guarded surprise because there has been no open discussion about entering the non-pharmaceutical medical cannabis market nor has it been placed on their pipeline. The company stated that "jurisdictions differ greatly in terms of regulatory requirements surrounding medical cannabis, which means that in some territories, QIXLEEF™ can be commercialized by TBP as a medical cannabis product." So Dania Scott is spearheading the launch of QIXLEEF™ under the trademark, ENJOUCA™, as a medical cannabis product in those territories, and they are using its robust clinical data package to do so, distributing their ENJOUCA™ branded products through the existing medical cannabis channels. Ms. Scott was named ENJOUCA™ Managing Director and report to Mr. Néron.

For other jurisdictions, QIXLEEF™ will remain a prescription drug product and commercialized to the major global markets. As a prescription drug, QIXLEEF™ will be available by prescription only, through pharmacies for breakthrough cancer pain, uncontrolled cancer pain and advanced cancer pain. The U.S. Phase 3 for Qixleef is expected to start in late 2021 or early 2022 at which time they will file the new drug application for it as a pharmaceutical drug. So ENJOUCA™ will bring the product to commercialization a couple of years ahead of schedule as a medical cannabis (not prescription pharmaceutical) product. Excellent move by Tetra. Surely Aphria is upbeat on this news.

According to the new Enjouca Managing Director today, "Tetra simply needed to strategically create distance between QIXLEEF™ and ENJOUCA™. These two brands will command different commercial execution from a supply, reimbursement, and promotional activity standpoint, due to different regulatory requirements. What is very positive is that we will be able to launch ENJOUCA™ in Canada during the second half of 2021. Patients and healthcare professionals will finally have a cannabinoid therapeutic option that is supported by strong evidence". That timeframe will allow time for Aphria to produce sufficient quantities of Enjouca (Qixleef) for the market. Persistence and patience pays off.
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