Tetra Bio Pharma signs commercialization agreement for CAUMZ in Mexico
Tetra Bio-Pharma announced that it has signed a definitive co-development and commercialization agreement with Alternavida S.A. de C.V. for the clinical development, marketing and distribution of CAUMZ in Mexico. Under terms of the agreement, Alternavida will be a clinical research collaborator for the clinical development of CAUMZ will fully fund two clinical trial sites in Mexico for the Serenity and fibromyalgia trials, and will be responsible for registering and commercializing CAUMZ 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 C$10M dollars and potentially allows Tetra to accelerate the enrollment process and ultimately the time required to complete the Phase 2 and Phase 3 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 C$125,000 as well as royalties on CAUM 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 in eight additional countries including Colombia, Ecuador, Chile, Panama, Costa Rica, Honduras, Peru and the Dominican Republic.