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TBP TO SUBMIT TO HC & BEGIN COMMERCIALIZATION OF OTC DRUGS

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Tetra Bio-Pharma Provides Management Update on Tetra Natural Health’s Commercial Activities
by @nasdaq on 30 Oct 2019, 08:00
   
Azevedos To Commercialize Awaye™ in Portugal, Tunisia and Mozambique in Q1 2020
Tetra to submit two non-prescription DIN applications in Canada
Tetra to commercialize non-prescription drugs in USA

OTTAWA, Oct. 30, 2019 (GLOBE NEWSWIRE) -- Tetra Natural Health (“TNH”) a wholly owned subsidiary of Tetra Bio-Pharma Inc., (“Tetra” or the “Company”) (TSX VENTURE:TBP) (OTCQB:TBPMF) is pleased to provide an update on its initiatives to bring its Awaye™ topical product for pain relief to the market globally and its activities to commercialize additional natural health products and non-prescription drugs in Canada and the USA. TNH is focused on entering into distribution partnerships for the commercialization of its OTC (Over-The-Counter) pain medications in the US$ 19 billion dollar market, which is expected to see steady growth according, to Future Market Insights. 
The portfolio of OTC drug products that Tetra is preparing to commercialize are at an advanced stage (i.e., DIN submission). There are no further required capital investment or additional clinical research necessary to bring these products to market. 

Tetra to submit its first two non-prescription DIN applications in Canada
Tetra confirms that it has completed the development of two OTC DIN products; one for the treatment of hemorrhoids 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.  The non-prescription drug applications are completed and will be submitted to Health Canada before the end of Tetra’s fiscal year ending November 30th, 2019.

Tetra also plans to release these products in USA market in 2020. In preparation for its 2020 product launch, Tetra is in contact with a contract manufacturer to set up the manufacturing and to obtain a National Drug Code (NDC) number from the U.S. Food and Drug Administration (FDA) for each drug. An NDC number is required for all OTC drugs sold in the USA.

Tetra has developed several other non-prescription drug products for the Canadian and USA Over-the-Counter (OTC) drug markets.  This OTC drug product line will contain beta-caryophyllene and will not require any clinical trial data to support its DIN application.  Tetra has created this product line to bring self-care therapies, that act on the CB2 receptor, to pharmacies and their consumers. 

Awaye™
Tetra is pleased to announce it has signed a Binding Term Sheet with Azevedos Indstria Farmacutica, S.A. (“Azevedos”) for the distribution of Awaye™ in Portugal, Tunisia, and Mozambique.  Tetra is eligible to receive an upfront payment, milestone payments, and 20% royalties on net sales.  Azevedos will also be responsible for manufacturing the product for the European market.  This is the first of several pharmaceutical partners that the corporation has entered into discussions and reached a commercial agreement.  These agreements are part of the strategy to launch the global commercial sale and distribution of Awaye™.

Since their foundation in 1775, to the present day, more than 200 years have passed and today the Azevedos Group is a well-established Portuguese pharmaceutical brand.  Their wide scope of activity ranges from development to distribution, leading manufacturing and exports to more than 60 regulated countries worldwide.  Azevedos has over 300 Marketing Authorizations that are manufactured in its certified facility and sold in over 80 countries worldwide.

Topical drugs can be an effective clinical alternative to oral pain medications for relieving local pain and avoiding the use of stronger pain medications for relief.  In 2017, according to Allied Market Research, the topical pain addressable market was valued 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.  

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 on cannabinoid type 2 (CB2) receptors.  It is sometimes also referred to as an atypical cannabinoid.  The double-blind, placebo-controlled 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 in daily activities was reduced by >2-points (clinically significant).

“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, said Richard Giguere, CEO of Tetra Natural Health”.

“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 stated Richard Giguere”.

Tetra is currently in early stage discussions for the commercialization of Awaye™ in Canada and the USA.


Additional pharmaceutical and natural products for commercialization
In addition, Tetra is in commercial agreement discussions with other pharmaceutical and natural product companies for the sale and distribution of several other approved natural health products containing beta-caryophyllene. These products will be available to consumers without prescription, in the natural product section of various retail outlets and online starting as early as Q1 2020. One of these products is a gel approved by Health Canada intended for the temporary relief of pain associated with cold sores, fever blisters and oral herpes.  Additional applications were also submitted for claims related to protecting and relieving minor skin irritations and itching due to rashes, eczema, and insect bites.  These latter products will be commercialized as the Company receives the approvals from Health Canada.

References:
Over-the-Counter Pain Medication Market will Exhibit a Steady 4.0% CAGR through 2028: Future Market Insights.  February 20, 2019
U.S. Topical Pain Relief Market Outlook – 2025.  Sayali Shinde , Onkar Sumant. Allied Market Research. June 2019.
Global Topical Pain Relief Market.  Allied Market Research. April 2019.
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.
For more information visit: www.tetrabiopharma.com
Source: Tetra Bio-Pharma