Drug maker wants to sell Cialis over the counter

INDIANAPOLIS — The maker of erectile dysfunction drug Cialis wants its pill sold to men without a prescription.

Under a licensing deal between Eli Lilly and Co. (LLY) and French drugmaker Sanofi (SAN), Cialis could become the first prescription drug for male impotence to be sold over the counter. The plan still needs approval from regulators, who would weigh the risks of allowing the drug to be sold without a doctor's visit.

The two companies hope for a 2018 launch of what they're calling Cialis OTC. That's the same year patents for Cialis are expected to expire in the United States and Europe, allowing cheaper generics to take over and effectively dry up Lilly's considerable profits from the drug.

Cialis generated $2.16 billion in sales last year and was Lilly's fourth best-selling drug.

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A plan to sell Cialis over the counter would allow the Indianapolis drugmaker to continue to profit from the drug as an impotence treatment.

Lilly didn't reveal financial details of the deal with Sanofi. Under the deal, Sanofi will be responsible for commercializing nonprescription Cialis wherever it receives approval while Lilly will manufacture Cialis for Sanofi. The drug, sold in tablet form, is made by Lilly in Puerto Rico.

Men don't want to go through the hassle and sometimes discussions with doctors. There is a need to self-diagnose.

Dave Ricks, Eli Lilly and Co.

Cialis has been prescribed to more than 45 million men since its launch in Europe in 2002 and in the United States a year later. The drug has been widely used and proven to be safe and effective, so it's a good candidate to sell over the counter, said Dave Ricks, a senior vice president at Lilly.

In addition, over-the-counter sales would be a safer option for men than buying illicit forms of Cialis online without a prescription, Ricks said. He said many of the Cialis tablets advertised online! are fake or adulterated.

A large unmet demand exists for over-the-counter Cialis because many men suffering from impotence don't feel comfortable talking to a doctor about the problem, Ricks said.

"Half of (American) men over 40 suffer ED," Ricks said. "But the current market (for prescription ED drugs) only represents a fraction (of potential patients). Men don't want to go through the hassle and sometimes discussions with doctors. There is a need to self-diagnose. We think that (over-the-counter) availability is key to helping guys" with impotence.

The first prescription erectile dysfunction drug to market was Pfizer's Viagra, introduced in the late 1990s. Pfizer applied in Europe several years ago to sell Viagra over the counter but later withdrew its request.

Eli Lilly's Cialis orange tablet was the second erectile dysfunction the FDA approved.(Photo: Eli Lilly and Co.)

Lilly said Sanofi will take the lead in pursuing regulatory approval to sell Cialis over the counter. One concern for regulators will be that Cialis isn't supposed to be taken with medicines called nitrates often prescribed for chest pain. The combination can cause a dangerous drop in blood pressure.

Regulators also might be concerned that impotence is sometimes a sign of other medical problems, which won't be discovered if men are allowed to buy Cialis without a checkup.

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Potentially, regulators could approve over-the-counter sales of Cialis only at certain doses and for some indications, Ricks said.

Lilly said it struck a deal with Sanofi to take the lead in Cialis OT! C because! Sanofi has experience in conducting consumer studies and gaining approval for over-the-counter formulations of other brand drugs, including allergy medications Nasacort and Allegra.