Tetra Bio-Pharma Acquires Exclusive Global Technology Rights to a Mucoadhesive Delivery Technology
Tetra Bio-Pharma Inc. (TSX:TBP)(OTCQB:TBPMF) is a leader in cannabinoid-derived drug discovery and development. The company announces that it has entered into an amended and restated license agreement with IntelGenx Corp. (IGX)(IGXT), a Canadian leader in pharmaceutical films, to acquire additional worldwide exclusive rights for the mucoadhesive delivery technology for its PPP-002 (Dronabinol) drug candidate. Tetra 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.
IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films. IntelGenx’s superior film technologies, including VersaFilm® and VetaFilm™, as well as VevaDermTM, its transdermal development and manufacturing capabilities, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offers significant benefits to patients and physicians for many therapeutic conditions.
IntelGenx’s highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx’s state-of-the-art manufacturing facility offers full service by providing lab-scale to pilot- and commercial-scale production.
Tetra Bio-Pharma 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.
In addition to the Dronabinol Soft Gel capsules, Tetra will bring forward a second cannabinoid derived medicine, with an enhanced intellectual property protection, for patients who experience nausea while undergoing chemotherapy. The global Chemotherapy Induced Nausea and Vomiting (CINV) market is estimated to reach $2.6Bn USD by 2022(1).
This new license agreement supersedes any previously ones signed between the parties. Under the terms of the agreement, Tetra has agreed to purchase the Adversa® technology, which can be applied to our global Dronabinol franchise, for three undisclosed milestones; 45% to be paid on November 15th 2020, 45% to be paid on March 1st 2021, and a final payment of 10% upon successful technology transfer to our Contract Manufacturing Organization. In addition, IntelGenx will receive a low single digit royalty on future net sales of Dronabinol mucoadhesive tablets.
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.
Dr. Guy Chamberland, CEO and CRO of Tetra commented: “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. Tetra is planning to file its PPP-002 (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.”
“The acquisition of 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. 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,” said Steeve Néron, Chief Commercial Officer.
“We are pleased to enter into this new license agreement which reflects the many potential therapeutic benefits of the Adversa® delivery technology,” said Dr. Horst G. Zerbe, CEO of IntelGenx.”