Tetra Bio-PharmaInc. (“Tetra” or “TBP”) today provides an update on its initiatives to bring its Caumz® (PPP011) inhalation drug product to the market.
OTTAWA, Oct. 21, 2019 (GLOBE NEWSWIRE) -- Tetra Bio-PharmaInc. (“Tetra” or “TBP”) today provides an update on its initiatives to bring its Caumz® (PPP011) inhalation drug product to the market.
The previous financing has allowed Tetra to successfully lay the foundation for execution of the treatment phase of its ongoing Phase 3 clinical trial and to advance the ophthalmic program (PPP003). The Serenity© trial is designed to provide regulators with data from a single well-designed pivotal clinical trial for an intended use involving a serious medical condition. This data will be substantiated by Tetra’s existing body of clinical and scientific data. When all diseases / indications are considered, the probability of achieving marking authorization and sales for a drug that has reached phase 3 is 58% (Clinical Development Success Rates 2006-2015. Thomas D.W. et al. June 2016.).
According to Guy Chamberland, CEO, “We have made tremendous progress and have reached the last stage of drug development. This is a major achievement for a biotechnology company.” Earlier this month, the corporation announced that the US FDA granted a drug-device combination product jurisdiction for its Caumz®-kit; a Caumz® drug combined with the Might Medic® medical device. This decision was the first step in Tetra’s strategy to bring this innovative and first in class drug to the market. According to Dr. Chamberland, “Tetra is executing the regulatory strategy it has described in the AIF (filed on June 18, 2019) and MD&A (filed on October 18, 2019) and in a relatively timely fashion.”
“The path towards commercialization has had many challenges, and I am very proud of the efforts of our entire staff in getting us to this point. Our team has done everything to ensure success. This pre-commercialization success also comes with additional requirements and development challenges for Tetra in 2020. It involves completing scale-up manufacturing and producing several batches of the commercial drug which requires significant time, effort and cost.” Since early summer 2018 Tetra has been implementing quality systems to be ready for this pre-commercialization phase and assessing various technologies to scale-up production to a commercial level. Government regulators do not approve drug products unless the Corporation is fully compliant with all the drug and device regulations (Good Manufacturing Practice in the Pharmaceutical Industry. Bhattarai S. et al. University of Edinburgh. July 2007). For small or large pharmaceutical companies, this compliance has a cost (The Cost of Developing Drugs Is Insane. That Paper That Says Otherwise Is Insanely Bad. Matthew Herper. Forbes, Oct 16, 2017).
As part of its June 2018 financing, Tetra has been able to significantly expand its number of clinical trial sites as well as position a major part of its clinical research to the USA. This strategic move allows Tetra to be in a better position as it targets selling in the world’s largest market.
“We are in active discussions with several North American pharmaceutical firms for the sale and distribution of Caumz® across North, Central and South America. We are evaluating the best path forward for Tetra and will update shareholders once we have a definite agreement with any potential partner. We believe this is the best path forward for us, as launching a commercial product in the U.S. requires the significant financial support. Strategic partnering will be key to a successful launch of an approved Caumz®-kit. Our plan is to maximize shareholder value as we move forward in developing our programs, evaluating potential partnerships, and seeking institutional support of our company,” commented Guy Chamberland.
These pharmaceutical companies are estimating CAUMZ™ USA sales peaking at $2Bn by 2029. Estimates are based on a patient derived model (Advanced Cancer Pain Prevalence: J Pain Symptom Manage. 2016 June;51(6):1070-1090). Peak sales are estimated be able to secure a 20% - 25% market share from the attainable patient pool. We believe these estimates remain conservative since these estimates only reflect the advanced cancer pain indication in their models. As previously announced Tetra intends to submit two supplemental marketing applications in breakthrough pain and fibromyalgia. Fibromyalgia affects 4% of the entire global population. Management believes that the $2Bn estimates, which are based solely on on-label promotion of Caumz®-kit within the advanced cancer pain indication are conservative.
Tetra has initiated discussions with financial strategic advisors, institutional private equity partners, and increased its visibility to US pharmaceutical and biotechnology market analysts. More and more Tetra share holder will read messages from financial and biotech journalists as we become the next cannabinoid pharma. Becoming a pharmaceutical company requires the support of Institutional investors and this cannot be achieved without strategic investment. Tetra is studying how it will make this transition with minimal impact on dilution. “We have no desire to continue to initiate financing the traditional way to bring Caumz® to market. For several months we have been studying various strategic investment formats and will continue to do so over the coming months as we try to find the best scenario for current share holders.” Commented Guy Chamberland.
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX-V: TBP) (OTCQB: TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a Health Canada approved, and FDA reviewed, clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. The Company has several subsidiaries engaged in the development of an advanced and growing pipeline of Bio Pharmaceuticals, Natural Health and Veterinary Products containing cannabis and other medicinal plant-based elements. 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 bio pharma industry by regulators, physicians and insurance companies.
For more information visit: www.tetrabiopharma.com
Source: Tetra Bio-Pharma
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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 this trial, the ability to obtain orphan drug status, 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. While no definitive documentation has yet been signed by the parties and there is no certainty that such documentation will be signed. 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:
Bruce Mackle
LifeSci Advisors LLC
646-889-1200
TetraInvestors@LifeSciAdvisors.com
Media Contact:
Andrew Mielach
LifeSci Public Relations
646-876-5868
amielach@lifescipublicrelations.com
Canada:
Carol Levine
Energi PR
514-288-8500 ext. 226
carol.levine@energipr.com
Source: Tetra Bio-Pharma
