U.S. Food and Drug Administration (FDA) allows evaluation of CAUMZ Kit as a combination drug/device product, providing clarity on regulatory approval pathway



This is a first step in the regulatory strategy to bring CAUMZ Kit to the market with additional FDA guidance anticipated by end of 2019

OTTAWA, Oct. 03, 2019 (GLOBE NEWSWIRE) -- Tetra Bio-Pharma Inc., (TSX-V: TBP) (OTCQB: TBPMF), a leader in drug discovery and development for cannabinoid-based therapeutics, today announced the U.S. Food and Drug Administration (FDA) has determined that the company’s CAUMZ Kit can be evaluated as a combination drug/device product. The CAUMZ Kit is comprised of two constituents: Tetra’s lead drug CAUMZ and the Mighty Medic device of Storz & Bickel, a wholly owned subsidiary of Canopy Growth. Based on the FDA’s determination, the CAUMZ Kit has been assigned to the Center for Drug Evaluation and Research (CDER) for premarket review and further assessment.

"We are pleased to have the CAUMZ Kit viewed by the FDA as a drug/device product and now have a clear regulatory pathway through CDER for development in the U.S. Storz & Bickel/Canopy is providing the medical device component, Mighty Medic, of the combination product to be tested in the Serenity trial and to be ultimately evaluated as part of the drug approval review process,” said Guy Chamberland, Ph.D., chief executive officer of Tetra Bio-Pharma. “This decision by the FDA is the first part of the regulatory strategy to bring the CAUMZ Kit to the market. We are fully engaged to be bringing the Mighty Medic vaporizer medical device to the market for the inhalation of prescription drugs. The Mighty Medic device was selected because it has a robust quality system that adheres to the FDA’s quality system regulations and conforms to European medical device directives. We look forward to working with the FDA to create the single regulatory file required for the marketing approval of the CAUMZ Kit as a drug/device combination product.”

Tetra has a co-development agreement with Canopy Growth Corporation, which originally was Storz & Bickel prior to its acquisition by Canopy. The Mighty Medic is not available in the U.S. as a medical device. This medical device will be used in the Serenity clinical trial under authorizations granted by the FDA.

About CAUMZ Kit

CAUMZ Kit is comprised of two constituent parts; a handheld Mighty Medic vaporizer, and two CAUMZ capsules coated with 17 mg delta-9-tetrahydrocannibinol and 5 mg cannabidiol contained in a PVC/aluminum blister pack. The drug component and device component will be linked together by the labelling of each component and developed for sale as one combination unit. The vaporizer, exclusively unique to Tetra’s drug delivery methods, is a portable, handheld, battery-powered device with an LED temperature display. Control buttons on the device set the temperature, and a removeable cooling unit with a disposable Lip piece with check valve is located on top of the filling chamber.

For the drug component, CAUMZ is coated onto the surface of a dosing capsule designed for insertion into the medical device. The dosing capsules, available in blisters, are individually packaged in a sealed thermoformed tray. CAUMZ drug dosing capsules and a fully assembled Mighty Medic for vaporization and inhalation of the generated vapor are required for therapy with CAUMZ and are provided in the CAUMZ Kit. CAUMZ drug dosing capsule blister cards will not be available without the Mighty Medic device.

About CAUMZ

CAUMZ, a cannabinoid-derived medicine using synthetic THC and CBD, is a non-opioid alternative in Phase 3 development for the treatment of pain and inflammation. The Phase 3 Serenity® trial for advanced cancer pain is currently recruiting patients at 20 clinical trial sites across the United States and Canada. Tetra continues to anticipate regulatory approval for CAUMZ by late 2020.

About Tetra Bio-Pharma Inc.

Tetra Bio-Pharma Inc. (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. Tetra Bio-Pharma has 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 its mission, 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.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in 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, including the expected timing of completion of the Private Placement; the size of the Private Placement; the participation of Tetra directors, officers and employees in the Private Placement, the satisfaction of the conditions of closing of the Private Placement and on the anticipated timeframes. 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, 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.

Investor Contact:

Bruce Mackle

LifeSci Advisors LLC

646-889-1200

TetraInvestors@LifeSciAdvisors.com

Media Contact:

Andrew Mielach

LifeSci Public Relations

646-876-5868

amielach@lifescipublicrelations.com

Canada:

Carol Levine

Energi PR

514-288-8500 ext. 226

carol.levine@energipr.com



Source: Tetra Bio-Pharma

Source: Tetra Bio-Pharma