Tetra is ready to submit its first New Drug Submission application to commercialize a THC-based prescription drug in Canada.
- Will facilitate the introduction of CAUMZTM
- Significantly reinforce our core business
- Allows Tetra to establish a revenue stream
OTTAWA, ON / ACCESSWIRE / September 30, 2020 / Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX:TBP.TO)(OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development, announced today that it has entered into a definitive agreement with a USA strategic partner to acquire the Canadian exclusive rights for Dronabinol Soft Gel capsules. Tetra will be submitting a New Drug Submission application in fiscal Q4 2020 to obtain its first DIN (Drug Identification Number) for a THC-based prescription drug.
The acquisition will allow Tetra to establish an immediate and direct commercial presence in Canada by promoting an existing cannabinoid derived prescription drug. This will allow Tetra to establish a revenue stream based on a synthetic cannabinoid drug for major markets in Chemotherapy Induced Nausea and Vomiting (CINV). The experience gained with Dronabinol will help to pave the way for the introduction of CAUMZTM to the marketplace. The addressable market is estimated to be $80M CDN by 2022(1). Tetra's intention is to gain experience with a cannabinoid derived medicine in the Canadian market in order to acquire strategic insight so that this will strengthen our discussion at the Global level with our partners.
Under the terms of the agreement, TBP has agreed to acquire Dronabinol Soft Gel capsules commercial rights for two undisclosed milestones, 50% at the approval of the transaction and the other 50% once the DIN is granted by Health Canada.
Dronabinol Soft Gel capsules are indicated in AIDS-related anorexia associated with weight loss and severe nausea and vomiting associated with cancer chemotherapy. Dronabinol DIN launch is expected in the first-half of 2021.
Dr. Guy Chamberland, CEO and CRO of Tetra commented: "This transaction is a key milestone for Tetra, as this will allow us to generate revenues. On the regulatory front, securing the Dronabinol data pack will allow TBP to move quickly to filing its New Drug Submission application, and expedite several of our future investigational new drug submissions including but not limited to PPP-002."
"The acquisition of Dronabinol soft gel capsules enables Tetra to accelerate its goal towards profitability and meet its strategic goal to become a key player in cannabinoid derived medicines globally. It is a major step in the transformation of the Company, allowing us to establish a direct commercial presence in Canada, so that when we introduce CAUMZTM we will be able to anticipate success stories and barriers. In the current context of cannabis legalization and significant shortages of nabilone, a drug used for chemotherapy-induced nausea and vomiting, our goal is to relaunch a high value therapeutic option with robust data. My goal has always been to address patients, healthcare professionals and shareholders expectations", said Steeve Néron, Chief Commercial Officer.
1Global Chemotherapy-induced Nausea and Vomiting (CINV) Market (Patient Pool Type: Aloxi, Kytril, Emend, and Netupitant-Palonosetron) - Global Opportunities and Forecast 2014-2022 Allied Market Research (assuming 3% market share in Canada)
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX:TBP.TO)(OTCQB:TBPMF), is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a FDA and a Health Canada approved clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. Our evidence-based scientific approach has enabled us to develop a pipeline of cannabinoid-based drug products for a range of medical conditions, including pain, inflammation, and oncology. 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 biopharma industry by regulators, physicians and insurance companies.
For more information visit: www.tetrabiopharma.com
Source: Tetra Bio-Pharma
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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.:
Tetra Bio-Pharma Inc.
Dr. Guy Chamberland, M.Sc., Ph.D.
Chief Executive Officer
Phone: + 1 (833) 977-7575
Alpha Bronze, LLC
Mr. Pascal Nigen
Phone: + 1 (646) 255-0433
Ms. Carol Levine APR, FCPRS
Phone: + 1 (416) 425-9143 ext. 226
Mobile: + 1 (514) 703-0256
SOURCE: Tetra Bio-Pharma
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