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Aphria (APHA) and Canopy Growth (CGC) protégé Tetra Bio-Pharma announced a partnership with 240-year-old Azevedos To Commercialize Awaye™ in the European market, Portugal, Tunisia and Mozambique in Q1 2020. Awaye is a successful Phase 3 clinical-trialed topical product for pain relief and their partnership with global Azevedos is the first of several pharmaceutical partners that the corporation has entered into discussions and reached a commercial agreement with. These agreements are part of Tetra Bio-Pharma's strategy to launch the commercial sale and distribution of Awaye™ immediately into the market globally in their first quarter, which begins December 1st.

The company also announced it is ready to submit two non-prescription DIN applications in Canada for the commercial market there, as well as emphasizing they are in negotiations to commercialize a number of non-prescription drugs in USA in addition to Awaye. Awaye has garnered a lot of attention from a number of big pharma suitors like Azevedos, with the big pharma negotiators stating they expect Tetra to garner 20%-25% of the total market for advanced cancer pain relief and reach $2 Billion in Sales by 2029 for their Caumz drug. The market for Awaye is not far behind that of Caumz, being around 80% of that size or more. Given the market frenzy for high quality cannabinoid and related products of the highest purity, with an emphasis on safety data, this puts Tetra in the front-runner's seat with a first-in-class drug, and clearly why they have big name suitors coming to call on them wanting to be the ones who drive the sales. Investors will soon see who they have signed as partners for a number of major regions, including the vast United States market. The portfolio of OTC drug products that Tetra is preparing to commercialize are at an advanced stage, obviously, and importantly for investors, there are no further required capital investments or additional clinical research necessary to bring these products to market. They must be dancing on the roof over there!

They are making these products available through key distributors in the USA market in 2020 and in preparation for the products launch, Tetra has been working with a contract manufacturer setting up the manufacturing of these over-the-counter drugs. These are OTC drugs and will have a US National Drug Control number issued from the FDA whom Tetra has been working with very successfully during all of their clinical trials the last four years, as FDA has been reviewing them to learn about cannabinoid research, and also the FDA recently as last Spring invited, yes, INVITED, Tetra to conduct its clinical trials in the United States, which Tetra immediately capitalized on and has now partnered with TEN excellent clinical trial sites in the US and is helping them get all the necessary paperwork, qualifications, certifications in order to begin their work in Tetra's ongoing Phase 3 clinical trial ASAP. They also expanded due to that to over ten sites in Canada as well; prior to that they just had a single clinical trial site. So big news. That offer by FDA, by the way, greatly expanded the capability of Tetra to conduct much larger clinical trials and conduct them in a faster way. All the better for cannabinoid research, Tetra is really breaking ground at the forefront of this thing.

My goodness, they are really rolling out the good news this week. Tetra is also informing us they have besides this, two OTC DIN products also coming to the market right away: one for the treatment of hemorrhoids to compete with Preparation H and the other for the temporary relief of aches and pains of muscles and joints associated with backache, lumbago, strains, bruises, sprains and arthritic or rheumatic pain, pain of tendons and ligaments to compete with Ben Gay and generic muscle rubs! Some investors are calling it "Ben Guy" after the CEO of Tetra, Dr. Guy Chamberland, who is also a Master Herbalist and former Royal Canadian Mounted Policeman, and a senior toxicologist with a bent on producing a clean, pure, safe product for consumers. The non-prescription drug applications are completed for these also, and will be submitted to Health Canada before the end of Tetra’s fiscal year ending November 30th, 2019. Working together on this, CEO Chamberland and Chairman of the Board Bill Cheliak, the former head of Panag Pharma, which Tetra recently merged with, have guided the merged company to create this advanced cannabinoid product line (which include related molecules such beta-caryophyllene found in cannabis, jasmine and other natural herbal products), to bring self-care therapies that act on the CB2 receptor to pharmacies and their consumers. This is based on both Dr. Guy's and Panag's team's decades of experience in this field. Dr. Raphael Mechoulam, the "Father of Cannabis Research" who discovered the endocannabinoid system, has long been a close associate advisor to Panag (now Tetra), and that tells you the quality of the work Tetra is involved in.

On the Awaye partnership license Tetra granted to Azevedo, Tetra is receiving an upfront payment, milestone payments, and 20% royalties on sales. Receiving 20% of sales ensures Tetra will be booking larger and larger revenues and earnings going forward as the drug launch rolls out throughout Europe, Africa and the Middle East. Investors should expect a very high sales and earnings growth rate early on for Tetra since they are utilizing large pharma to be their licensed sales distributors worldwide and it's such a dynamic product line. This ensures they achieve market saturation in the fastest possible way and eliminate multiple expenses, allowing their big partners to handle those areas as they do so well. For example, Azevedos will also be responsible for manufacturing the product for the European market, as well as their other markets. Allied Market Research states that the topical pain addressable market was valued in 2017 at US$ 2.3 billion in USA and at US$ 7.5 billion globally. The global market is expected to reach US$ 13 billion by 2025 due to growing prevalence of arthritis in the aging population, higher demand from athletes and patients seeking alternatives with lower side effects, which these products highlight for consumers who are demanding safe alternatives. This market is expected to grow at 4% CAGR over the next ten years. Like Awaye, it is likely Tetra's Ben Gay competitor and its Preparation H competitor will garner 20%-25% of that market. This is likely a conservative figure, coming from big pharma research as it is, since that is the standard practice in making such estimates.

Head of Tetra Biopharma's subsidiary Tetra Natural Health, Richard Giguere, stated:
“We are thrilled to be advancing our relationship with Azevedos, the oldest Pharmaceutical brand name in Portugal with facilities in Mozambique and Tunisia and exporting to more than 60 countries worldwide. In addition, the company possesses state of the art manufacturing facilities, employed by major Pharmaceutical companies from around the world and has the potential to manufacture a number of our non-prescription, prescription and natural health products for the European market.”

Tetra also released this proprietary information about Awaye in this week's sales and distribution agreement announcement with Azevedos:
"Awaye™ is a topical product, first of its class, to help relieve local pain in patients with both acute and chronic pain. Awaye™ is based on the properties of beta-caryophyllene, a terpene found in cannabis sativa, but commercially available from other botanical sources. This terpene has a full agonist action (it binds like CBD binds) on cannabinoid type 2 (CB2) receptors. It is (therefore) sometimes also referred to as an atypical cannabinoid (and it IS found is high percentages in cannabis, by the way). The double-blind, placebo-controlled (phased clinical) trial of Awaye™ evaluated the safety and efficacy for the treatment of pain caused by osteoarthritis of the knee. Sixty percent (60%) of patients reported improvement in their condition and 62% of participants were satisfied with the treatment. After three (3) weeks of use, pain scores were reduced by 23% and the Pain Interference [Chart scores (1-10 rating, typically) of clinical trial participants used to diagnose their] pain levels in daily activities was reduced by 2 points (23%, which is clinically significant)." I have to agree, having worked in statistics, that these results are very statistically significant. This product came to Tetra through their merger with Panag Pharma and is considered to be one of their key assets leading to the merger, so that's important to know. Tetra and Panag made a very good call when they decided to merge. This week's announcement makes that clear. Let the revenue and earnings begin!
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