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Tetra Receives FDA Orphan Drug Designation for its Ophthalmic Clinical Program


Tetra's PPP003 cannabinoid drug receives Orphan Drug Designation for the Prevention of Proliferative Vitreoretinopathy

OTTAWA / ACCESSWIRE / April 15, 2020 / Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX-V:TBP) (OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development, is pleased to announce that it has received U.S. Food and Drug Administration (FDA) Orphan Drug Designation for its synthetic cannabinoid PPP003 (HU308) in the prevention of proliferative vitreoretinopathy.

Proliferative vitreoretinopathy (PVR) is a vision-threatening condition that develops in approximately 10% of patients who undergo reparative primary retinal detachment surgery and in about 50% of patients with open globe injury. PVR is defined as the growth of membranes on both surfaces of the detached retina and on the posterior surface of the detached vitreous gel.

The pathophysiology of PVR includes the formation of a subretinal or epiretinal membrane (ERM) that can subsequently contract, causing a new retinal detachment or failure of a surgically corrected detachment. The standard of care involves repeat surgery but unfortunately the outcome is not always successful as surgical intervention does not address the inflammatory basis of the condition and increases the risk of serious ocular infection (e.g. endophthalmitis). "Our research in an experimental model of PVR has demonstrated that the synthetic cannabinoid, PPP003, can prevent this condition through activation of the type 2 cannabinoid receptor. If Tetra's clinical trial can successfully demonstrate prevention of PVR in humans, PPP003 would become the first prescription eye medication approved for this condition," commented Dr. Melanie Kelly CSO, Tetra Bio-Pharma Inc.

"We are very pleased to have received this new Orphan Drug Designation (ODD) from the FDA. Tetra now has 3 drugs that obtained Orphan Drug status from the FDA! This new designation is a direct result of Tetra's acquisition of Panag Pharma Inc and its solid intellectual property and scientific advancement in cannabinoid treatment of ophthalmic conditions. This includes USA and European granted patents making Tetra a world leader in cannabinoid ophthalmic drug development," said Dr. Guy Chamberland, CEO and Chief Regulatory Officer of Tetra Bio-Pharma. Dr. Chamberland further added, "Tetra will be requesting a Type B meeting with the US FDA to discuss the clinical development program for this Orphan Drug indication. The Company will provide an update to shareholders once the meeting is confirmed."

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 and approved, 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. Could we work in "existing regulatory standards of safety and clinical evidence for pharmaceutical products".

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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 product or any other product, 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. 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.

For further information, please contact Tetra Bio-Pharma Inc.:

Investor Contact:

Alpha Bronze, LLC
Mr. Pascal Nigen
Phone: + 1 (646) 255-0433

SOURCE: Tetra BioPharma

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