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TBP SIGNS COMEERCIALIZATION AGRMNT WITH ALTERNAVIDA 4 CAUMZ

[Humanist]

Tetra Bio-Pharma Signs Definitive Commercialization Agreement for CAUMZ™ in Mexico With Alternavida S.A.

December 02, 2019 08:00 ET | Source: Tetra Bio-Pharma

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 CAUMZ^TM (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 CAUMZ^TM, 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 CAUMZ^TM 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 CAUMZ^TM, will fully fund two clinical trial sites in Mexico for the Serenity and fibromyalgia trials, and will be responsible for registering and commercializing CAUMZ^TM 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 CAUMZ^TM 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 CAUMZ^TM 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.