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Press Release

Tetra Bio-Pharma Targets Multi-Billion Dollar Fibromyalgia Market


Posted on: 16 Jul 18

Co-development deal announced with Germany’s Storz & Bickel aims to improve delivery of cannabinoid-based pain relief

ORLEANS, Ontario, July 16, 2018 (GLOBE NEWSWIRE) -- Tetra Bio-Pharma Inc., a leader in cannabinoid-based drug discovery and development (TSX VENTURE:TBP) (OTCQB:TBPMF), today announced a co-development agreement with Storz & Bickel to use a specialized medical device known as the Mighty Medic, in combination with its PPP001 prescription drug as well as with additional indications and a future proprietary cannabinoid formulation. The Mighty Medic is a portable herbal vaporizer for cannabis use approved by Health Canada as a Class 11 medical device and as such, is eligible for reimbursement. The agreement allows Tetra to effectively bring PPP001 to patients suffering from fibromyalgia and other chronic pain conditions, significantly expanding the market potential for PPP001. 

Fibromyalgia affects about 4 million U.S. adults or about 2% of the adult population1. The cardinal symptom associated with the condition is pain that can be deep, sharp, dull, throbbing, or aching, affecting the muscles, tendons, and ligaments around the joints throughout the entire body. Treatments aimed at pain relief are the primary treatment intervention including an increasing use of opioids. Among the most commonly prescribed medications used to treat fibromyalgia are Lyrica, Cymbalta, Xyrem and Vimpat. 

PPP001 is a cannabinoid-based product that is currently being studied in a Phase 3 Health-Canada approved clinical trial for advanced cancer pain. Tetra will use a bridging strategy to leverage the clinical data that has been generated with the smokable formulation of PPP001, to expedite the marketing requirements in these indications and reduce the time needed to bring these products to market. The combination product of PPP001 with the Mighty Medic would signify an important economic benefit for patients. 

According to Dr. Gordon D. Ko, MD, FCFP(EM), FRCPC, PhD, “fibromyalgia is difficult to treat and there is no one "magic bullet". As practitioners we have the daunting task of moving our patients from unrelenting neuropathic pain to improved function and a better quality of life,” said Dr. Ko. “The clinical use of medical cannabis in the management of fibromyalgia suggests these patients obtain significant relief. Moreover, the potential to reduce opioid use for these patients is a foremost consideration of using the Mighty Medic to deliver the cannabinoids and terpenes contained in PPP001 by inhalation.” Dr. Ko is Medical Director, Fibromyalgia clinics and Adjunct Lecturer at The Canadian Centre for Integrative Medicine, (Markham, Ontario) and Sunnybrook Health Sciences Centre, University of Toronto.

As a prescription drug, PPP001 will be eligible for insurance coverage. In Canada, only Class II, III and IV medical devices are eligible for reimbursement under provincial health care insurance programs. 

Tetra and Storz & Bickel will also collaborate on the development of another inhalation cannabinoid-based prescription drug. The drug device combination product will target cancer patients and Tetra will use a similar bridging strategy to minimize marketing requirements and reduce time-to-market.

About Storz & Bickel
STORZ & BICKEL built the first factory in the world for the manufacture of medical herbal vaporizers in Tuttlingen, Germany, a town with almost 500 medical device manufacturers. Tuttlingen is reputed to be the center of medical technology, where the first factory to produce surgical instruments was established more than 150 years ago.

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 approved, and FDA reviewed, clinical program 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.

More information at: www.tetrabiopharma.com
Source: Tetra Bio-Pharma

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

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 this or any other clinical trial, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, 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. While no definitive documentation has yet been signed by the parties and there is no certainty that such documentation will be signed. 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

Investor Relations Contact:
Robert (Bob) Bechard
Executive Vice President, Corporate Development and Licensing
Tetra Bio-Pharma Inc.
514-817-2514
investors@tetrabiopharma.com

Media Contact:
energi PR 
Carol LevineLana Power
514-288-8500 ext. 226416-425-9143 ext. 201

References
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1 https:// https://www.cdc.gov/arthritis/basics/fibromyalgia.htm

GlobeNewswire
globenewswire.com

Last updated on: 16/07/2018

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