NEWS - INCASE YOU DIDNT SEE 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 Nron, 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)