Cialis OTC approval sought
pharmafile | June 2, 2014 | News story | Sales and Marketing | Cialis, ED, OTC, Sanofi, lilly
Sanofi and Eli Lilly have announced they are to push ahead with plans to seek regulatory approval for erectile dysfunction (ED) drug Cialis to be made available over the counter (OTC).
Approved in Europe in 2002 and the US a year later, Cialis (tadalafil) is only available at present by prescription: but the companies have signed a new licensing agreement – the terms of which are not disclosed – seeking to change that.
Sanofi has bought exclusive rights to apply for approval in the US, Europe, Canada and Australia, and the French company will also be able to market the brand as an OTC product.
The firm says it “anticipates providing Cialis OTC after expiration of certain patents”. The PDE-5 inhibitor made $2.16 billion worldwide last year and, Lilly says, more than $14 billion since launch.
“Millions of men worldwide trust Cialis to treat ED,” says David Ricks, president, Lilly Bio-Medicines. “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 OTC is a highly regulated process that is data-driven and scientifically rigorous,” Ricks adds. “Together with Sanofi, we look forward to working closely with regulatory authorities to define the proper actions and necessary precautions to help patients use OTC Cialis appropriately.”
Cialis has indications in around 120 countries including ED, and the signs and symptoms of benign prostatic hyperplasia (BPH).
“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,” says Vincent Warnery, senior VP, at Sanofi’s global consumer healthcare division.
“The opportunity to forge an industry-leading partnership that adds to Sanofi consumer healthcare’s leading portfolio and successful track record of OTC switches reinforces consumer health care as a major growth platform for Sanofi,” he adds.
Adam Hill
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