Today's the day Eli Lilly was expected to get a Food and Drug Administration decision on the first-ever one-a-day impotence drug. Right now, the company sells Cialis for use as needed. But men could pop this one every day--like an aspirin or multi-vitamin--so the drug would always be "on board."
Yeah, I know this will lead to a whole new genre of late-night TV jokes about the nearly 10-year-old erectile dysfunction (ED) drug class. But in all seriousness, urologists (the doctors who specialize in treating ED) say there's a market for a one-a-day.
Dr. Kevin McVary at the Northwestern University School of Medicine, who does consulting and/or works on clinical trials for the ED drugmakers, says there's a "sizeable minority" of patients who would take Cialis every day. He told me that he works with couples who don't like their foreplay interrupted by what can be a mood-killing pause to take an ED drug and then sit around waiting for it to take effect. With a one-a-day version, he says, that worry is gone.
Cialis is the one that lasts 36 hours. And it takes effect faster than Pfizer's Viagra and Levitra from Bayer, GlaxoSmithKline and Schering-Plough . Viagra and Levitra also only last a few hours or so. Sales growth of the ED drugs has slowed, but it's still around a $3-billion-a-year business. Cialis sales, for example, were up 27% in the third quarter.
But here's the rub. A Lilly spokesperson says the FDA has asked for more information on one-a-day Cialis, so a decision on approving it will likely be delayed beyond today. Deutsche Bank's Barbara Ryan is out with a research note to clients this afternoon saying the agency wants "additional analyses of existing data". So, that presumably means Lilly doesn't have to go back to square one and do more tests, it just has to crunch more numbers or something.
But you gotta love Ryan's take on all this: "Once daily dosing could appeal to men with ED who are eternal optimists or have relatively active sexual lives, and we expect it could provide some modest incremental growth to the Cialis franchise." Deutsche owns at least one percent of LLY, makes a market in the stock and has done and wants to do more investment banking for the company.
The Lilly spokesperson told me the drug is intended for men "who anticipate having sex at least twice a week." It's already approved in Europe where Lilly is launching it now. American men will just have to wait.