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Sanofi wins rights to market O-T-C version of Eli Lilly's Cialis.

INDIANAPOLIS -- Cialis manufacturer Eh Lilly & Co. has reached a licensing deal allowing Sanofi SA to sell a nonprescription version of the pill in major markets if regulators approve--a factor that some industry analysts suggest is no guarantee.

The prescription erectile-dysfunction drug garnered about $2.2 billion in global sales last year, surpassing rival Viagra, which had sales of $1.9 billion, according to a report in the Wall Street Journal.

The companies say over-the-counter Cialis could provide easier treatment access for impotence sufferers, and could also help stem the illicit on line sale of fake or stolen Cialis. The few O-T-C options currently found in pharmacies include non-Food and Drug Administration-approved dietary supplements that claim to enhance male potency.

Sanofi is acquiring the exclusive rights to seek regulatory approval for O-T-C Cialis in the United States, Europe, Canada and Australia, and to begin selling it after the expiration of certain patents for tadalafil, Cialis' generic name.

Patents are due to expire no sooner than 2017 in the United States and Europe.

But the O-T-C project could face hurdles, including safety concerns, says the report. Sanofi will have to demonstrate to government drug regulators that men can correctly decide whether to take the drug--and use it safely--without a doctor's guidance. Cialis, like Viagra, can cause a sudden drop in blood pressure if it is taken with certain heart and blood pressure medications, causing fainting or even death, among other adverse events linked to the drugs.

Pfizer Inc. applied for European regulatory approval to switch Viagra to O-T-C status in 2007, but withdrew its application a year later after a regulatory advisory body expressed concerns that such a product would be misused.

Sanofi and Lilly declined to disclose financial terms of the deal. But the two drug firms would likely encounter intense questions over how they would ensure an O-T-C version would be taken only by legitimate, adult impotence sufferers.

An FDA spokeswoman said the agency would have to discuss with the companies what kind of data it needed to support the switching of an impotence drug to O-T-C status. The FDA generally considers a drug's toxicity, the potential for harm, and the method of use when determining whether it is safe and effective for self-medication as directed in proposed labeling.

The regulatory agency has previously rejected some attempts at prescription-to-O-T-C switches of other kinds of drugs because of safety concerns, including Merck& Co.'s bid to sell an O-T-C version of its cholesterol-lowering drug Mevacor. The agency has, however, approved switches to O-T-C status for drugs for allergies, heartburn and smoking cessation.

Indianapolis-based Lilly said clinical testing and post-marketing data show Cialis is generally safe and effective, and has been used by about 45 million men since its introduction.

Both companies contend that the availability of an O-T-C version could help stem the proliferation of fake or substandard Cialis advertised online.

The Cialis deal reflects the industry's initiative to extend sales of big-selling brands at the end of their patent exclusivity periods, including switching them to O-T-C medicines. Several drug makers have struck deals recently to bolster their O-T-C medicine businesses, including Bayer AG's planned $14.2 billion purchase of Merck's consumer health business.

The impotence drug category came to life in the late 1990s when Pfizer introduced Viagra, the first of a class of new pills known as PDE5 inhibitors, which work by increasing blood flow to the penis and facilitating erections.
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Title Annotation:RX/Branded Drugs
Publication:Chain Drug Review
Date:Jul 7, 2014
Words:572
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