Tesofensine for treatment of obesity

Tesofensine, a triple monoamine reuptake inhibitor, is positioned for obesity. Tesofensine has been evaluated in Phase 1 and Phase 2 human clinical studies with the aim of investigating treatment potential with regards to obesity, Alzheimer’s disease and Parkinson’s disease. Tesofensine demonstrated strong weight reducing effects in Phase 2 clinical studies in obese patients. In general, Tesofensine has been administered to more than 1,300 patients and is well tolerated.

In February 2016, Saniona entered into a collaboration with Medix about the development and commercialization of Tesofensine and Tesomet in Mexico and Argentina. Medix has exclusive rights to develop and commercialize Tesofensine and Tesomet in the two countries and will finance and be responsible for the clinical development and regulatory filings. According to Medix, the current market for prescription medicine for obesity in Mexico is about US$ 250 million. In August 2017, Medix initiated a Phase 3 study for Tesofensine in obese Mexican patients. Topline results were reported in December 2018 and showed that primary and secondary endpoints were met in the Phase 3 obesity registration trial.

Medix also intends to initiate Phase 2 and Phase 3 studies with Tesomet, which is considered to have additional benefits for certain patients and may potentially expand the market for obesity and its comorbidities such as type 2 diabetes.

Saniona retains all rights to Tesofensine and Tesomet including the exclusive rights to use the clinical data developed by Medix in the rest of the world. Medix will pay Saniona regulatory milestone payments and double-digit royalties on product sales.

Productos Medix, S.A de S.V (“Medix”) is a Mexican pharmaceutical company established in 1956. Medix is primarily focused on treatment of overweight and obesity. Medix is the market leader for treatment of overweight and obesity in Mexico where it offers the most comprehensive product and service line. Medix’s leading product for treatment of overweight and obesity is among the top ten pharmaceutical products in Mexico overall. Medix has earned several recognitions for its social responsibility through its participation in philanthropic programs for the benefit of the Mexican population and for its educational efforts involving thousands of doctors in Mexico. Medix has subsidiaries in Argentina and certain other South American countries.