Tetra will leverage its modern Dronabinol details pack acquisition to rapidly file its next New Drug Submission software to commercialize yet another THC-centered prescription drug
- Additional reinforces its patent security and existence cycle management on its dronabinol franchise
- Proven in a scientific trial to have less side results and increased bioavailability
- Solidifies Tetra’s earnings 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 advancement, declared these days that it has entered into an amended and restated license agreement with IntelGenx Corp. (IGX)(IGXT), a Canadian chief in pharmaceutical movies, to get added all over the world exceptional legal rights for the mucoadhesive delivery technological innovation for its PPP-002 (Dronabinol) drug candidate. Tetra is planning to file a 505(b)(2), in the US, in early 2022 to receive its second Drug Identification Quantity (DIN) for a THC-centered prescription drug.
In addition to the Dronabinol Soft Gel capsules, Tetra will carry ahead a next cannabinoid derived medicine, with an enhanced mental house safety, for patients who encounter nausea even though going through chemotherapy. The international Chemotherapy Induced Nausea and Vomiting (CINV) sector is estimated to arrive at $2.6Bn USD by 2022(1).
This new license agreement supersedes any previously types signed concerning the get-togethers. Underneath the terms of the settlement, Tetra has agreed to acquire the Adversa® technology, which can be used to our worldwide Dronabinol franchise, for three undisclosed milestones 45% to be paid on November 15th 2020, 45% to be paid out on March 1st 2021, and a last payment of 10% on thriving technologies transfer to our Contract Producing Business. In addition, IntelGenx will get a minimal single digit royalty on long term internet income of Dronabinol mucoadhesive tablets.
The Adversa® mucoadhesive shipping technological innovation is expected to limit the to start with-move rate of metabolism, boost bioavailability, lessen gastro-intestinal publicity and facet-outcomes, and eventually boost item balance.
Dr. Dude Chamberland, CEO and CRO of Tetra commented: “We have attained a further critical action in our Dronabinol/CINV strategic program. This transaction is strengthened by the acquisition of the Dronabinol Soft Gel details pack. Tetra is arranging to file its PPP-002 (Dronabinol Adversa®) product candidate in early 2022 and we anticipate approval in the 2nd half of 2022. We will also be expanding the indication to incorporate opioid reduction statements.”
“The acquisition of Dronabinol Adversa® mucoadhesive pill shipping and delivery technologies will present additional overall flexibility to sufferers and health care providers. The indicator of CINV will stay the identical as the comfortable gel. Having said that, the facet impact profile looks a lot more beneficial devoid of affecting Dronabinol efficacy. This delivery process will be handy primarily for people who are dealing with challenges linked with swallowing delicate gel capsules. However, this takes place relatively routinely with people acquiring chemotherapy. On the professional front, the Adversa® technologies will produce a superior therapeutic value for each people and healthcare companies although generating a lot more value for our shareholders as Tetra’s Dronabinol franchise will profit from a far more strong patent security,” claimed Steeve Néron, Main Business Officer.
“We are delighted to enter into this new license settlement which displays the quite a few prospective therapeutic advantages of the Adversa® shipping engineering,” stated Dr. Horst G. Zerbe, CEO of IntelGenx.”
1 World Chemotherapy-induced Nausea and Vomiting (CINV) Sector (Individual Pool Sort: Aloxi, Kytril, Emend, and Netupitant-Palonosetron) – Global Prospects and Forecast 2014-2022 Allied Sector Research
IntelGenx is a foremost drug delivery enterprise centered on the progress and manufacturing of pharmaceutical movies. IntelGenx’s excellent film systems, which include VersaFilm® and VetaFilm™, as perfectly as VevaDermTM, its transdermal progress and producing capabilities, enable for subsequent technology pharmaceutical solutions that address unmet clinical desires. IntelGenx’s progressive product or service pipeline gives major benefits to patients and doctors for numerous therapeutic conditions.
IntelGenx’s highly qualified crew offers complete pharmaceuticals services to pharmaceutical companions, like R&D, analytical system advancement, medical checking, IP and regulatory solutions. IntelGenx’s state-of-the-artwork manufacturing facility presents comprehensive provider by supplying lab-scale to pilot- and commercial-scale manufacturing. For a lot more information, check out www.intelgenx.com
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX:TBP) (OTCQB:TBPMF), is a biopharmaceutical chief in cannabinoid-based drug discovery and enhancement with a Food and drug administration and a Health Canada approved clinical program aimed at bringing novel prescription medicines and solutions to people and their healthcare vendors. Our proof-centered scientific solution has enabled us to produce a pipeline of cannabinoid-based mostly drug products and solutions for a selection of medical situations, which include agony, inflammation, and oncology. With individuals at the core of what we do, Tetra Bio-Pharma is concentrated on giving demanding scientific validation and security info essential for inclusion into the current biopharma industry by regulators, medical professionals and coverage providers. For a lot more details stop by: www.tetrabiopharma.com
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Some statements in this release may possibly consist of ahead-hunting details. All statements, other than of historical simple fact, that address functions, events or developments that the Corporation thinks, expects or anticipates will or may perhaps occur in the upcoming (which includes, without having limitation, statements concerning possible acquisitions and financings) are ahead-seeking statements. Forward-on the lookout statements are usually identifiable by use of the terms “may possibly”, “will”, “need to”, “continue on”, “hope”, “anticipate”, “estimate”, “think”, “intend”, “approach” or “venture” or the unfavorable of these words or other variants on these phrases or similar terminology. Ahead-hunting statements are subject to a variety of pitfalls and uncertainties, lots of of which are beyond the Firm’s ability to command or forecast, that may perhaps cause the actual benefits of the Firm to vary materially from people talked over in the forward-looking statements. Components that could result in real results or events to differ materially from latest anticipations include things like, between other matters, with out limitation, the inability of the Firm to get hold of enough financing to execute the Company’s business program competition regulation and predicted and unanticipated expenses and delays, the achievements of the Company’s research and development tactics, including the achievements of this solution or any other products, the applicability of the discoveries designed therein, the effective and well timed completion and uncertainties similar to the regulatory procedure, the timing of medical trials, the timing and results of regulatory or intellectual home decisions and other hazards disclosed in the Firm’s community disclosure file on file with the suitable securities regulatory authorities. Even though the Business has attempted to recognize critical variables that could cause real success or occasions to differ materially from all those explained in ahead-looking statements, there may perhaps be other factors that cause effects or occasions not to be as expected, estimated or supposed. Audience need to not area undue reliance on ahead-searching statements. The forward-seeking statements provided in this information launch are designed as of the date of this information launch and the Firm does not undertake an obligation to publicly update this sort of forward-searching statements to mirror new details, subsequent gatherings or in any other case unless needed by applicable securities laws.
For even more details, be sure to get in touch with Tetra Bio-Pharma Inc.:
Trader Get in touch with:
Tetra Bio-Pharma Inc
Dr. Guy Chamberland, M.Sc., Ph.D.
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Mr. Pascal Nigen
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