Tetra will leverage its recent Dronabinol data pack acquisition to rapidly file its second New Drug Submission application to commercialize another THC-based prescription drug
- Further reinforces its patent protection and life cycle management on its dronabinol franchise
- Shown in a clinical trial to have fewer side effects and enhanced bioavailability
- Solidifies Tetra's revenue stream
OTTAWA, ON / ACCESSWIRE / October 21, 2020 / Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX:TBP)(OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development, announced today 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.
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."
1 Global 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
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. For more information, visit www.intelgenx.com
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX:TBP) (OTCQB:TBPMF), 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. For more information visit: www.tetrabiopharma.com
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Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words "may", "will", "should", "continue", "expect", "anticipate", "estimate", "believe", "intend", "plan" or "project" or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company's ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company to obtain sufficient financing to execute the Company's business plan; competition; regulation and anticipated and unanticipated costs and delays, the success of the Company's research and development strategies, including the success of this product or any other product, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions and other risks disclosed in the Company's public disclosure record on file with the relevant securities regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.
For further information, please contact Tetra Bio-Pharma Inc.:
Tetra Bio-Pharma Inc
Dr. Guy Chamberland, M.Sc., Ph.D.
Chief Executive Officer
Phone: + 1 (833) 977-7575
Alpha Bronze, LLC
Mr. Pascal Nigen
Phone: + 1 (646) 255-0433
Ms. Carol Levine APR, FCPRS
Phone: + 1 (416) 425-9143 ext. 226
Mobile: + 1 (514) 703-0256
SOURCE: Tetra Bio-Pharma