Tetra Bio-Pharma Inc (TSE:TBP) (OTCQB:TBPMF) (FRA:JAM1), a leader in cannabinoid-derived drug discovery, said Wednesday that it has struck an amended license agreement with IntelGenx Technologies Corp (OTCMKTS:IGXT) (CVE:IGX) (FRA:0IL), a leader in pharmaceutical films, to acquire additional worldwide exclusive rights for the mucoadhesive delivery technology for its PPP-002 (Dronabinol) drug candidate.
The Canadian biopharmaceutical company is planning to file a 505(b)(2), in the US, in early 2022 to obtain its second Drug Identification Number (DIN) for a THC-based prescription drug.
In addition to the Dronabinol Soft Gel capsules, a cannabinoid-derived prescription drug aimed at treating AIDS-related anorexia and severe nausea linked with chemotherapy, Tetra will advance a second cannabinoid derived medicine for patients who suffer nausea while having chemotherapy.
The global Chemotherapy-Induced Nausea and Vomiting (CINV) market is expected to touch $2.6 billion by 2022, according to Allied Market Research.
According to the agreement, Tetra will buy the Adversa technology which can be applied to its Dronabinol drug franchise, for three undisclosed milestones: 45% to be paid on November 15, 2020, 45% to be paid on March 1, 2021, and a final payment of 10% on successful technology transfer to the firm’s contract manufacturing organization.
In addition, IntelGenx will “receive a low single-digit royalty on future net sales of Dronabinol mucoadhesive tablets,” said the company.
Tetra said the Adversa mucoadhesive delivery technology is expected to “limit the first-pass metabolism, improve bioavailability, reduce gastro-intestinal exposure and side-effects, and finally enhance product stability.”
Tetra CEO Guy Chamberland said: "We have achieved another critical step in our Dronabinol/CINV strategic plan. This transaction is strengthened by the acquisition of the Dronabinol Soft Gel data pack.”
Dr Chamberland added: “Tetra is planning to file its Dronabinol Adversa product candidate in early 2022 and we expect approval in the second half of 2022. We will also be expanding the indication to include opioid reduction claims."
Meanwhile, Tetra’s Chief Commercial Officer Steeve Néron said the acquisition of the Dronabinol Adversa mucoadhesive tablet delivery technology will offer “more flexibility to patients” and healthcare providers.
“The indication of CINV will remain the same as the soft gel. However, the side effect profile looks more beneficial without affecting Dronabinol efficacy. This delivery system will be useful especially for patients who are experiencing issues associated with swallowing soft gel capsules,” added Néron.
“Unfortunately, this occurs rather frequently with patients receiving chemotherapy. On the commercial front, the Adversa technology will yield a better therapeutic value for both patients and healthcare providers while generating more value for our shareholders as Tetra's Dronabinol franchise will benefit from a more robust patent protection."
Contact the author Uttara Choudhury at firstname.lastname@example.org
Follow her on Twitter: @UttaraProactive