Sanofi and Eli Lilly and Co. have entered an agreement to pursue regulatory approval of OTC Cialis (tadalafil) for the treatment of men with erectile dysfunction (ED). Sanofi will gain exclusive filing and marketing rights to Cialis OTC in the U.S., Europe, Canada and Australia upon approval. Cialis had worldwide sales of $2.16 billion in 2013. Financial and other terms of the agreement were not disclosed.
 
“This agreement provides us with an opportunity to work with Lilly, a leader in men’s health, to transform how this important medicine is offered to millions of men throughout the world,” said Vincent Warnery, senior vice president, Global Consumer Healthcare Division, Sanofi. “The opportunity to forge an industry-leading partnership that adds to Sanofi Consumer Healthcare’s leading portfolio and successful track record of over-the-counter switches reinforces consumer health care as a major growth platform for Sanofi.”
 
“Millions of men worldwide trust Cialis to treat ED. We are pleased to work with Sanofi to pursue a path that could allow more men who suffer from ED to obtain convenient access to a safe and reliable product without a prescription,” said David Ricks, senior vice president, Lilly, and president, Lilly Bio-Medicines. “Switching a medicine to over-the-counter is a highly regulated process that is data-driven and scientifically rigorous. Together with Sanofi, we look forward to working closely with regulatory authorities to define the proper actions and necessary precautions to help patients use over-the-counter Cialis appropriately.”