Sanofi proposes to switch Cialis OTC

PARIS — Sanofi and Eli Lilly and Co. on Wednesday announced an agreement to pursue regulatory approval of nonprescription Cialis (tadalafil). Cialis is currently available by prescription only worldwide for the treatment of men with erectile dysfunction.

"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," stated Vincent Warnery, SVP 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," added David Ricks, SVP 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."

Under the terms of the agreement, Sanofi acquires the exclusive rights to apply for approval of Cialis OTC in the United States, Europe, Canada and Australia. Sanofi also holds exclusive rights to market Cialis OTC following Sanofi's receipt of all necessary regulatory approvals. If approved, Sanofi anticipates providing Cialis OTC after expiration of certain patents. 

Terms of the licensing agreement were not disclosed.

Cialis was first approved by the European Medicines Agency in 2002, then by the U.S. Food and Drug Administration in 2003, for the treatment of erectile dysfunction. Ultimately, Cialis has received approval in more than 120 countries for indications that vary by country. Cialis reached $2.2 billion in worldwide sales in 2013 and has recorded total global sales of more than $14 billion since launch. 

To date, more than 45 million men worldwide have been treated with Cialis, the companies stated.

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