Tetra Bio-Pharma to acquire Canadian exclusive rights for Dronabinol Soft Gel capsules

Tetra Bio-Pharma Inc (TSE:TBP) (OTCQB:TBPMF) announced Wednesday that it has entered into a definitive agreement with a strategic US partner to acquire the Canadian exclusive rights for Dronabinol Soft Gel capsules, a cannabinoid-derived prescription drug aimed to treat AIDS-related anorexia and severe nausea and vomiting associated with chemotherapy. 

In a statement, Tetra also said it will be submitting a New Drug Submission application in its fiscal fourth quarter of 2020 to obtain its first DIN (Drug Identification Number) for a THC-based prescription drug.

The company said the Dronabinol acquisition means the establishment of an immediate and direct commercial presence in Canada by promoting an existing cannabinoid derived prescription drug — allowing Tetra to establish a revenue stream based on a synthetic cannabinoid drug for major markets in chemotherapy-induced nausea and vomiting (CINV). 

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The experience gained with Dronabinol will help to pave the way for the introduction of its CAUMZTM treatment to the marketplace, Tetra said. 

The addressable market is estimated to be C$80 million by 2022. 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 its discussion at the global level with its 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. The Dronabinol DIN launch is expected in the first-half of 2021, Tetra said. 

“This transaction is a key milestone for Tetra, as this will allow us to generate revenues,” said CEO Dr Guy Chamberland. “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.”

Steeve Néron, chief commercial officer, added: “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.”

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