Tesofensine is a triple monoamine reuptake inhibitor. It is a new chemical entity and has not been made commercially available previously. Tesofensine will be provided in tablets and the formulation of tesofensine is covered by patent applications and issued patents expiring in 2036. In addition, the company expects to obtain data exclusivity, which provides protection for at least five years in Mexico and the U.S. and ten years in Europe after market approval.
Saniona’s partner Medix has completed a Phase 3 registration trial for tesofensine in December 2018. The trial met its primary endpoints and Medix expects to apply for a new drug application in Mexico during 2019 and to launch the product in 2020. Tesofensine has demonstrated strong weight reducing effects in Phase 2 and Phase 3 clinical studies in obese patients. In the Phase 3 registration trial, patients reached an average weight loss of 10% over 24 weeks and more than half of the patients lost more than 10% in weight. Tesofensine has been administered to more than 1,700 patients and is well tolerated.
Mexico ranks among the most obese countries in the world. It is estimated that more than 70% of the 128 million Mexicans are overweight or obese. Eight in ten deaths are caused by chronic, non-commnicable diseases that are strongly linked to the overweight and obese population. Standardized mortality rates for diabetes, acute myocardial infarction, and hypertension have increased dramatically. As of 2012, diabetes - associated with obesity - was the largest single cause of death in Mexico. According to Medix, the current market for prescription medicine for obesity in Mexico is about US$ 250 million of which Medix has about 50 percent by volume and value. The current market for prescription medicine for obesity in Mexico is dominated by old generics. Tesofensine is believed to be more efficacious and better tolerated than the existing products.
In February 2016, Saniona entered into a collaboration with Medix for the development and commercialization of tesofensine and Tesomet in Mexico and Argentina. Medix holds an exclusive license to commercialize tesofensine in Mexico and Argentina, while Saniona is entitled to milestone payments and double-digit royalties on product sales. 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 is a Mexican pharmaceutical company established in 1956 and primarily focused on the treatment of excess weight and obesity. Medix is the market leader for the treatment of excess weight and obesity in Mexico, offering the most comprehensive product and service line. Medix’s leading product for treatment of excess weight 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.