- Tetra Estimates Net Sales reaching $675M USD by 2027
- Tetra is evaluating potential commercial partners to launch QIXLEEF™ in USA
OTTAWA, ON / ACCESSWIRE / December 7, 2020 / Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX:TBP) (OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development, today provided an update on the potential US market for QIXLEEF™, a botanical cannabinoid-derived medicine that meets USA cGMP regulatory requirements. This botanical drug product composition has a fixed ratio of THC and CBD. The product is inhaled through a medical device (vaporizer) and will be first indicated in advanced cancer patients with inadequately controlled pain.
Based on a conservative market penetration and patient-based model, Tetra estimates potential net sales of $675M USD by 2027. Tetra is in the process of evaluating a potential strategic partner to run its commercial execution in USA. It is still premature to provide details on royalty level, upfront, and milestone payments.
Leading up to an expected Market Approval from the FDA in 2023 will be completion of the Phase II trial in 2021, Phase III trial in early 2022 and New Drug Application (NDA) submitted in 2022. Market Approval typically follows 9-10 months following NDA submission.
The patient-based model assumes that Tetra will secure a market approval from the FDA for its QIXLEEF™ in advanced cancer patient with inadequately controlled pain with a launch late 2023. Tetra also assumes that the QIXLEEF™ kit (QIXLEEF™ and its accompanying medical vaporizer) will be reimbursed by Health Maintenance Organizations (HMO). Our forecast also reflects the second planned indication in breakthrough pain which should follow soon after our first NDA through a supplemental marketing approval application (supplement to New Drug Application; sNDA). Our forecast remains conservative as it does not reflect potential opioid sparing usage.
Finally, QIXLEEF™ safety have been established through traditional dose escalation Phase I trials and an in-depth study of the composition of inhaled volatile organic compounds. In addition, the NDA will be supported with data on the metabolite profile, pharmacokinetics, pharmacodynamics and exposure to neutral and acidic forms of phytocannabinoids. Tetra is currently running a Phase II trial in the USA called PLENITUDE© and preparing the European Phase III trial.
Dania Scott, Senior Vice President, Commercial Strategy commented, "Tetra is leading the way with inhalation cannabinoid therapy in an ever-evolving therapeutic space. There are no precedents to follow in the pharmaceutical industry. QIXLEEF™ proprietary safety and dosing data, and fast acting effect can alleviate crippling pain for patients in need of immediate relief. Tetra believes that QIXLEEF™ has the potential to enable patients to significantly reduce their use and dependence on opioids. QIXLEEF™ therapeutic potentials and its addition to physicians' armamentarium will help evolve the quality of life for patients and their caregivers."
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