Alternavida to launch and fund 2 clinical sites in Mexico as part of the clinical research collaboration in the commercialization agreement
Collaboration potentially allows Tetra to accelerate Phase 3 (Serenity) and Phase 2 (fibromyalgia) enrollments with projected cost savings of CAD$10 million
OTTAWA, Dec. 02, 2019 (GLOBE NEWSWIRE) — Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSX-V:TBP) (OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development, today announced that it has signed a definitive co-development and commercialization agreement (“Agreement”) with Alternavida S.A. de C.V. (“Alternavida”) for the clinical development, marketing and distribution of CAUMZTM (PPP011) in Mexico.
“As the opioid crisis spreads from North America to other countries like Mexico1, controlling the global opioid epidemic has become one of the health challenges of our decade. Alternavida’s vision to open clinical sites for trials with CAUMZTM, and seeking drug approval, testifies to its leadership as a pharmaceutical company dedicated to the health and wellness of Mexicans,” commented Dr. Guy Chamberland, CEO and Chief Regulatory Officer of Tetra Bio-Pharma. Chamberland added, “We have had discussions with numerous potential partners, but Alternavida had a clear interest in joining us in developing and bringing CAUMZTM to market. Our relationship will grow over the years, and we look forward to working with this forward-thinking company as we join forces in Mexico.”
Under terms of the agreement, Alternavida will be a clinical research collaborator for the clinical development of CAUMZTM, will fully fund two clinical trial sites in Mexico for the Serenity and fibromyalgia trials, and will be responsible for registering and commercializing CAUMZTM in Mexico.
The clinical trial sites will be fully compliant with FDA and Health Canada requirements and are expected to be up and running in early 2020. The funding of the two sites represents a cost saving of CAD$10 million dollars and potentially allows Tetra to accelerate the enrollment process and ultimately the time required to complete the Phase 2 (fibromyalgia) and Phase 3 (Serenity) trials as the Company pursues approvals in the U.S. and Canada. The cost savings is based on clinical trial costs, such as investigator and site costs, patient interventions and assessments, as well as study monitoring costs.
Additionally, Tetra will also receive a one-time license fee of CAD$125,000 as well as royalties on CAUMZTM sales in Mexico of 10% in year one, 12.5% in year two, and 15% in years three to fifteen.
Finally, Alternavida has been granted a Right of First Refusal to commercialize CAUMZTM in eight additional countries including Colombia, Ecuador, Chile, Panama, Costa Rica, Honduras, Peru and the Dominican Republic.
“We are thrilled to have signed this clinical development and commercialization agreement with Alternavida, as it provides non-dilutive funding for two clinical sites as well as a solid commercial footprint in Mexico, with the potential to expand to eight additional territories in Latin America,” stated Dr. Chamberland. “Tetra will now be operating clinical sites in three countries: Mexico, Canada, and the U.S., boosting our enrollment potential.
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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About Alternavida S.A. de C.V.
The Alternavida Group began operations in 1997 with the commitment of addressing the needs of the Mexican Health Sector. Alternavida’s initial focus was in the commercialization and access to therapeutic technologies of high specialty products / therapies in the areas of oncology, immunology, blood derived products, and others. Alternavida’s group of companies are now involved in the manufacturing of oncology and other branded generic products as well as partnering with innovative companies to market their therapies in Mexico. Throughout the years we have learned how to build long lasting partnerships that allows us to better serve our customers and patients.
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.
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