On November 6, Saniona announced that Productos Medix S.A. de S.V. (Medix) has not yet received approval from the Mexican regulatory agency, COFEPRIS, for tesofensine as a treatment for obesity. Medix has engaged with the agency to clarify the situation and the path forward, as it appears that COFEPRIS may not yet have reviewed the full data package.

Saniona’s November 6 press release was based on a very brief update from Medix. Since then, and after a more thorough review of the communication between COFEPRIS and Medix, Saniona has come to understand that the agency may not yet have completed a comprehensive assessment of the data package submitted. Thus, Medix and Saniona believe that COFEPRIS may not yet have reviewed the entire application package submitted by Medix.

While Saniona recognizes the importance of transparency for the company’s stakeholders, Medix is the primary applicant for the approval and manages the process in line with its knowledge of the Mexican market and regulatory landscape. The role of Saniona is restricted to support Medix in this effort.

Medix is conducting a collaborative dialogue with COFEPRIS, which COFEPRIS has indicated a willingness to continue. Out of respect for this process, Saniona must refrain from further comments.