TBP Tetra Bio Pharma Inc

PANAG Pharma Inc. (PANAG), a wholly owned subsidiary of Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX-V: TBP) (OTCQB: TBPMF), a bio-pharmaceutical company engaged in cannabinoid-based drug discovery and development, is pleased to provide investors with an update on the activities of PANAG including, but not limited, to its innovative and patented formulations for the treatment of uveitis  which will enter Phase 2 in late 2019.

The acquisition of PANAG and the products at various stages of development, is a perfect fit for Tetra’s business model by providing a deeper pipeline of products to attract strategic commercial partners to distribute these products in Canada, the USA and around the world. 

“As a result of this acquisition, we have added highly qualified experts in cannabinoid science and medicine as well as a wealth of drug discovery and early phase drug development expertise and experience. Panag and Tetra Bio-Pharma will join forces to achieve noteworthy regulatory and clinical milestones. Our long term looks very promising, the synergies of the two companies may yield attractive returns for our investors” said Dr. Guy Chamberland, CEO, CSO of Tetra.

The following Panag products will be available to consumers without a prescription from their physician (e.g., natural product section of the pharmacy) and will be made commercially available in late 2019.  

The following products have already been approved by Health Canada and have received a Natural Product Number:

• Topical A, a cream for treating osteoarthritis, joint and muscle pain
• Beta C + Zinc, a gel for the treatment of Cold sores
• Beta C + Benzocaine a cream to be used in treating hemorrhoids

In June 2019, Tetra anticipates completion of Panag’s Phase 3 type clinical trial (Protocol ID: Panag-001) of its Topical-A pain cream. 

This study consisted of a randomized, double-blind, placebo-controlled crossover trial with open label extension evaluating Topical-A against placebo. At the end of the randomized controlled phase of the trial all participants will be given open-label Topical-A to be administered over the subsequent 3 weeks.  The Primary Endpoint was the evaluation of improvement in pain interference as measured by the Brief Pain Inventory (BPI) in individuals who are experiencing pain due to osteoarthritis of the knee.  The Secondary Endpoints were: Confirmation of safety of the topical cream when used daily over 10 weeks. Further evaluation will include overall patient satisfaction with the products tested.

Repurposing Product Candidates  

Tetra is currently repurposing existing topical products which will benefit from the addition of ß-caryophyllene (a powerful terpene) and the Multiplexed Molecular Penetration Enhancer ("MMPE™"), a patented technology developed by Tetra’s partner Crescita™.  The MMPE™ will provide increased permeability of active ingredients through the skin thereby providing an improved delivery to the therapeutic target (joints & bones, muscles etc.).   

Milestones (NPN products)				Key dates
Results of Panag-001 (Topical-A)				June 2019
Ongoing negotiations with commercial partners				Summer 2019
Launch of two repurposed products (NPN)				Q1 2020

The following products are regulated as drugs and, if approved, will be prescribed (Rx) by physicians. 

A pilot study with PPP-003 ophthalmic drug in the treatment of indolent corneal ulcers in companion animals

On May 2, 2019 Panag Pharma announced that its pilot clinical study to evaluate the tolerability and potential efficacy of its PPP003 ophthalmic drug in the treatment of indolent corneal ulcers in companion animals has been authorized by the Veterinary Drugs Directorate (VDD), Health Canada. VDD granted the Experimental Studies Certificate to the veterinary ophthalmologists that will be performing the clinical study for Panag.

Repurposing Product Candidates 

Tetra is also currently repurposing existing topical prescription drug products which will benefit from the addition of ß-caryophyllene combined again with the Multiplexed Molecular Penetration Enhancer ("MMPE™"), a patented technology developed by our partner Crescita™. The MMPEÔ will provide increased permeability of active ingredients through the skin thereby providing improved delivery to the therapeutic target (joints & bones, muscles etc.).  

Interstitial Cystitis Product Candidate

Panag has also developed therapies, along with intellectual property, for the treatment of interstitial cystitis.  Tetra plans to start commercializing some of these products in 2020

Milestones (Drug development)		Key dates
Launch of the Veterinary Pilot Study in indolent corneal ulcers					June 2019
Pre-IND Meeting with the FDA on the ophthalmic program					June 2019
Launch of the Phase 1 and 2 in Uveitis and Painful Dry Eye					Q4 2019
Filing of two repurposed (DIN) products with Health Canada					Q4 2019
Medical food approval Interstitial Cystitis Milestone(first generation product)					Q1 2020

About Tetra Bio-Pharma:

Tetra Bio-Pharma (TSX-V: TBP) (OTCQB: TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a Health Canada authorized, and FDA reviewed, clinical trials aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. The Company has several subsidiaries engaged in the development of an advanced and growing pipeline of Bio Pharmaceuticals, Natural Health and Veterinary Products containing cannabis and other medicinal plant-based elements. With patients at the core of what we do, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing bio pharma industry by regulators, physicians and insurance companies.

For more information visit: www.tetrabiopharma.com

Source: Tetra Bio-Pharma

About Panag PharmaPanag Pharma Inc. is a Canadian based bio-tech company focused on the development of novel cannabinoid-based formulations for the treatment of pain and inflammation. Panag believes that pain relief should be safe, non-addictive and above all; effective. The Panag Pharma team of PhD scientists and medical doctors are among the world’s leading researchers and clinicians in pain treatment and management. They bring a combined experience of over 100 years in research and clinical care of people dealing with chronic pain and inflammatory conditions. Panag’s current pipeline of pain relief products include formulations for the topical application to the skin, the eye and other mucous membranes. Recently approved by Health Canada and currently undergoing clinical trials, Panag Pharma’s Topical A OTC provides a new approach to the treatment of chronic pain and inflammation.

Forward-looking statements

Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words "may", "will", "should", "continue", "expect", "anticipate", "estimate", "believe", "intend", "plan" or "project" or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company's ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company to obtain sufficient financing to execute the Company's business plan; competition; regulation and anticipated and unanticipated costs and delays, the success of the Company's research and development strategies, including the success of the products developed by Panag and its other drug candidates, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process including the applications for Orphan Drug Designation, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions and other risks disclosed in the Company's public disclosure record on file with the relevant securities regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.

Tetra Bio-Pharma Contact:

Steeve Néron Senior Vice President Marketing & Medical Affairs. 514-232-2851Investors@tetrabiopharma.com 

Investor Contact:

Pierre Boucher, CPA, CMAPartner, Executive Vice-President514-731-000 ext: 237