French drug company Sanofi will seek to sell Eli Lilly and Co.’s erectile dysfunction drug Cialis without a prescription after the companies reached an agreement on marketing rights for the orange pills.
Sanofi will apply for approval of Cialis as an over-the-counter treatment in the United States, Europe, Canada and Australia, and will market the drug after certain patents expire, the Paris-based company said in a statement Wednesday, without disclosing the terms of the agreement with Indianapolis-based Lilly.
The deal hinges on regulatory approval in each country—a big question mark, according to analysts.
The plan gives Sanofi access to a drug that garnered $2.16 billion in sales last year, and will face generic competition starting in 2017.
The deal also fits with Sanofi CEO Chris Viehbacher’s interest in consumer health-care acquisitions. Sanofi was among the bidders for Merck & Co.’s over-the-counter unit, people with knowledge of the matter said in March, before Bayer AG bought the division for $14.2 billion.
The Cialis agreement “reinforces consumer health care as a major growth platform for Sanofi,” Vincent Warnery, senior vice president of Sanofi’s global consumer health-care division, said in a prepared statement.
Sanofi does have a track record of taking a previous prescription drug to over-the-counter status. It began selling allergy medicine Allegra without a prescription in the United States in 2011 after receiving Food and Drug Administratin approval.
Cialis competes with Pfizer Inc.’s Viagra, which had worldwide sales of about $1.9 billion in 2013. The New York-based drugmaker reached an agreement in December with Teva Pharmaceuticals Ltd. that permits the Israeli drugmaker to market a generic version of Viagra in the U.S. starting in December 2017, or earlier under certain circumstances.
More than 18 million Americans older than age 20 suffer from erectile dysfunction, according to Johns Hopkins University’s Bloomberg School of Public Health.
"Millions of men worldwide trust Cialis to treat ED," said Lilly Senior Vice President David Ricks in a prepared statement. "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. 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."
Lilly shares were up 32 cents, or 0.5 percent, early Wednesday morning, to $60.05 each.