Tetra Bio-Pharma Inc (TSE:TBP) (OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery, talked about its commercial strategy to bring Dronabinol Soft Gel capsules, a cannabinoid-derived prescription drug aimed to treat AIDS-related anorexia and severe nausea and vomiting associated with chemotherapy to patients.
In a statement on Wednesday, Tetra also said it will be submitting a marketing application to obtain a prescription Drug Identification Number (DIN) for the Dronabinol Soft Gel capsule in the fourth quarter of this year. The company expects the approval for the DIN to come through by the first half of 2021.
Tetra has obtained the Canadian exclusive rights for Dronabinol Soft Gel capsules from a US strategic partner who will be manufacturing the 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).
Dronabinol was withdrawn from the Canadian market several years ago, said the company due to “quality issues” associated with the stability of the THC medicinal ingredient and not because of sales. Tetra said that the quality of the manufacturing process would ensure the stability of the THC in the soft gel capsule. The CINV market is estimated at around $2.6 billion, according to Allied Market Research.
In parallel, Tetra is planning for a second DIN application for the same indication (CINV). The company expects this second marketing application to occur nearly one year after the first submission. Tetra’s PPP-002 development program, an assumed better formulation of dronabinol, with a mucoadhesive route of administration, has already received a greenlight from the US Food and Drug Administration (FDA) to seek marketing approval under the 505(b)(2) pathway.
In Canada, PPP-002 will enjoy an expedited approval as Tetra is using a regulatory strategy similar to the US 505(B)(2). “This will give Tetra greater options if the company is ever faced with a loss of exclusivity on the soft gel capsules,” said the company.
Meanwhile, Tetra CEO Dr Guy Chamberland said: “The acquisition of the Dronabinol Data Pack triggered numerous commercial opportunities for us. This is an exciting time as Tetra rapidly begins to monetize its’ clinical assets and transforms into a commercial pharmaceutical company. This has always been our vision.”
Tetra Chief Commercial Officer Steeve Néron said teh company's CINV commercial strategy will be able to address "unmet medical needs for patients, give more therapeutic options to healthcare professionals and reward the company's loyal shareholders."
"Tetra will always have a strategy to protect its CINV franchise, this is key. My many years of pharma experience has reinforced our knowledge that you do not build a commercial operation and risk a genericization the next day," added Néron.
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