- DIN submission to be completed in Q4 2020
OTTAWA, ON / ACCESSWIRE / October 7, 2020 / Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX:TBP) (OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development, is pleased to provide an update on its commercial strategy to bring innovative therapies to patients suffering from chemotherapy induced nausea and vomiting (CINV).
Tetra will be submitting a marketing application to obtain a prescription Drug Identification Number (DIN) for the dronabinol soft gel capsule in Q4 2020 and expects approval of the DIN in the first half of 2021. Tetra has obtained the rights from a USA strategic partner who will be manufacturing the drug product. Dronabinol was withdrawn from the Canadian market several years ago. This was because of quality issues associated with the stability of the THC medicinal ingredient and not because of the sales volume. In fact, sales were material in nature. Tetra confirms that the quality of the manufacturing process ensures the stability of the THC in the soft gel capsule. Tetra is also confident that it now has a commercial product ready for the market and will be able to supply the market without any anticipated shortages. CINV represents a global addressable market of $2.6 Bn (1).
With the legalization of cannabis, patients and healthcare professionals have been demanding cannabinoid-derived prescription drugs that meet the same high standard as for all other Canadian approved medications. Patients will be able to obtain a prescription for dronabinol from a physician and then obtain the drug from their pharmacist. This is the medical process that patients sought to achieve through the Supreme Court of Canada. Access to cannabinoid-derived therapies like dronabinol by health professionals is critical to the safety and care of patients. As an approved prescription drug, dronabinol would be eligible for reimbursement from private insurance plans or public pharmacare programs.
This marketing application launches Tetra's commercial operations, in parallel Tetra is planning for a second DIN application for the same indication (CINV). The second innovative proprietary THC drug is patent protected. Tetra expects this second marketing application to occur approximately 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 green light from the USA 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 USA 505(B)(2). This will give Tetra greater options if the company is ever faced with a loss of exclusivity (LOE) on the soft gel capsules.
Finally, Tetra is also working on a third drug candidate, an inhaled THC formulation using its Mighty Medic® - dosing capsule kit intellectual property. This is the same technology used by Tetra for CAUMZ™ and QIXLEEF™.
Dr. Guy Chamberland, CEO and CRO of Tetra commented: "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. Now our shareholders can understand Tetra's vision after having remained silent for a long time on the development of PPP002. Our promise to shareholders has been to become a cannabinoid pharmaceutical company that brings innovative therapies to patients. We are excited to finally state that the DIN submission will be completed in Q4 2020."
"Today we are announcing our CINV commercial strategy which will be able to address unmet medical needs for patients, give more therapeutic options to healthcare professionals and reward our 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. Before announcing this marketing application, Tetra developed a strategy with a life cycle vision to maintain its lead as an innovator and provider of cannabinoid-derived drugs to patients. I know of few big pharmaceutical companies who cannot substantiate the same argument. Guy and I are simply thrilled", said Steeve Néron, Chief Commercial Officer.
(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 (assuming 3% market share in Canada)
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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Forward-looking statements
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.:
Investor Contact:
Tetra Bio-Pharma Inc
Dr. Guy Chamberland, M.Sc., Ph.D.
Chief Executive Officer
Phone: + 1 (833) 977-7575
[email protected]
Alpha Bronze, LLC
Mr. Pascal Nigen
Phone: + 1 (646) 255-0433
[email protected]
Media Contact:
energi PR
Ms. Carol Levine APR, FCPRS
Phone: + 1 (416) 425-9143 ext. 226
Mobile: + 1 (514) 703-0256
[email protected]
SOURCE: Tetra Bio-Pharma