OTTAWA, ON / ACCESSWIRE / November 4, 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 market of its new drug, ARDS-003. Based on a conservative market penetration and patient-based model, Tetra estimates potential revenues from royalties on net sales, milestone and upfront payments of over $500 million USD by 2026.
The patient-based model assumes low to moderate penetration of the COVID-19 market along with a small penetration of the sepsis market. The latter assumes a small penetration during ongoing clinical trials of ARDS-003 in sepsis-related indications to expand claims through supplemental marketing approval applications (supplement to New Drug Application; sNDA).
ARDS-003 is an optimized sterile nano-emulsion of a synthetic compound that meets pharmaceutical quality standard for an intravenously administered drug in the treatment of systemic inflammation responses including systemic inflammatory response syndrome (SIRS), sepsis, severe sepsis, septic shock, cytokine release syndrome (CRS) & cytokine storm syndrome (CSS), acute respiratory distress syndrome (ARDS) and multi-organ disfunction syndrome (MODS).
The first indications that Tetra is targeting are Sars-CoV-2 related and include CRS, ARDS and survival claims. All these outcome measures have a significant impact on health care costs to governments. Reduction in time spent in the ICU and oxygen support therapies will have a significant cost saving and free up medical staff and facilities for regular medical procedures (e.g., cancer- and cardiac-related surgeries) that impact all of us. MODS and pulmonary fibrosis can have a post-survival impact on patient care and the ability to return to normal life and represent a significant economic cost for the health care system. The MODS and pulmonary fibrosis outcomes will be part of additional claims and filed as part of supplemental marketing approval applications (sNDA).
ARDS-003 is not a vaccine for COVID-19, it is a therapeutic. Tetra hopes that a vaccine will soon be available. However, it is estimated that 35% of people may not respond to a COVID-19 vaccine. As a result, patients who are severely affected by the COVID-19 virus may benefit from the therapeutic value of ARDS-003. The impact of vaccination has been considered in Tetra’s long-range operating plan.
Dr. Guy Chamberland, CEO and CRO commented, “Tetra is dedicated to developing ARDS-003 as a new therapeutic for reducing the severity of the exaggerated inflammatory responses that lead to acute respiratory distress or sepsis. Our focus is both on patient survival and post-survival care. Tetra’s science and innovation in exaggerated inflammatory reactions is among the top in the world. Our recent preclinical studies show that this drug will also play a role in post-survival patient care. Excluding COVID-19, the market potential of ARDS-003 is enormous. The potential revenues to Tetra are based on a conservative market penetration of the entire ARDS, sepsis, and COVID-19 markets. We are very confident that this drug will play a significant role in addressing the needs of these markets.”
About Global Sepsis Market
The World Health Organization (WHO) describes sepsis as a life-threatening multi-organ dysfunction caused by the immune response to an infection. When not treated adequately, it can result in septic shock, multiple organ failure and death¹.
According to the WHO, in 2017 there were 48.9 million cases of sepsis and 11 million sepsis-related deaths worldwide accounting for roughly 20% of all deaths.
About Cancer Related Sepsis Market
Hospitalization due to infection is a common complication for patients living with cancer. Immunosuppression in cancer patients, resulting from cancer therapy or due to the cancer itself, leads to severe infection, which is a frequent cause of death in this population. More than 1 in 5 sepsis hospitalizations is cancer-related and is associated with 8.5% of all cancer deaths. In addition, the readmission rate of 30 days after hospitalization is higher after a cancer-related sepsis admission (23.2%) than a non-cancer-related sepsis admission (20.1%). Sepsis and the related exaggerated inflammatory reactions also have a pharmacoeconomic impact on costs of health care of cancer patients².
About Trauma-Related Sepsis Market
Trauma is a major cause of death in North America and is responsible for approximately six million deaths per year worldwide³. Trauma associated tissue injury triggers an inflammatory response that is required for healing and defense against bacteria and viruses. In addition, the operative procedures promote a pro-inflammatory response. These can become exaggerated leading to SIRS or sepsis and septic complications (e.g. ARDS and MODS). 39.5% of deaths that happen after trauma occur in the hospital⁴. Despite current modern health care, the incidence of mortality associated with post-traumatic sepsis in the hospital remains between 19.5% and 23% of septic trauma patients.
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.