First of two Viagra rivals OK'd for sale

By Carey Goldberg, Globe Staff, 8/21/2003

The Food and Drug Administration has approved the first serious competition for Viagra, the little blue blockbuster that revolutionized the treatment of impotence -- and more rivals are on the way.

Levitra, a drug that combats erection problems in much the same way as Viagra but reportedly more quickly, taking effect in as little as 16 minutes, is expected to become available in pharmacies within weeks following the FDA approval late on Tuesday.

A third drug, Cialis, which also works similarly but lasts much longer, offering 36 hours or more of improved erections, is awaiting a final FDA decision late this year and could come to the US market within months, its makers say. Both drugs are already sold in Europe.

With Levitra and Cialis on their way and other impotence treatments under development, Viagra appears on the verge of losing its status as the only drug for the erectile dysfunction problems believed to affect some 30 million men in the United States.

The pill brought impotence into the open and brought in billions of dollars for its maker, Pfizer Inc., but now it will have to fight for market share. Stay tuned, market analysts say, for a battle to get men's attention during Sunday football games; the makers of Levitra, Bayer and GlaxoSmithKline, have already signed on the services of legendary coach Mike Ditka.

Viagra is a wonderful drug, said Dr. Irwin Goldstein, director of Boston University's Institute of Sexual Medicine, but "now it's five years later, and there is competition, and I think all of this is very good for the field."

In particular, he said, some men fear Viagra because of the perceived health risk: "They link the word `Viagra' to the words `heart attack,' " Goldstein explained, noting that the risk is very slight. "I think having a new medication that doesn't have that sort of baggage may be very beneficial to the field."

In truth, Levitra poses heart hazards similar to Viagra. Men who are taking nitrate medication like nitroglycerin to treat chest pain or alpha blockers for blood pressure or prostate problems are not supposed to take Levitra, according to Bayer and GlaxoSmithKline. The FDA does not recommend the drug for people whose heart disease makes sex dangerous or who have had a recent heart attack or stroke.

In clinical trials of Levitra among more than 5,000 men, the most common side effects reported were headaches, flushing, indigestion, and nasal stuffiness. A few patients reported abnormal vision.

Viagra, Levitra, and Cialis all work by blocking an enzyme to allow better blood flow to the penis, and all have been shown to be effective at helping at least six or seven of every 10 men who have erection problems.

No studies have pitted Viagra directly against Levitra, but market analysts predict that the two drugs will be battling it out in the US consumer market.

Viagra had Bob Dole as a poster boy; Levitra will use former Chicago Bears coach Ditka for an "educational campaign" called "Tackling Men's Health," said Nancy Bryan, vice president for marketing in men's health for Bayer Pharmaceuticals.

Bayer has also signed a sponsorship deal with the National Football League, and Bryan said it hopes to reach 120 million men through ads during football games.

And Levitra's price, Bryan said, "is going to be competitive with Viagra." Viagra generally costs $10 or $12 a pill, though it is often covered by insurance.

Levitra already has some enthusiastic fans. One of Goldstein's patients, a 68-year-old diabetic who identified himself only as Jason, said the drug worked for him so much better than Viagra that "I told Bayer I wanted to open my mouth under the conveyor belt."

But a Pfizer spokesman challenged the claims that Levitra acts faster or better than Viagra. (The usual time given for Viagra to take effect is an hour, but Pfizer said that in tests, it often acts faster.)

"We don't see it as much competition, to tell you the truth," said the spokesman, Daniel Watts. "It's another choice for patients, but based on the data and the labeling the FDA has given the product, they're not superior to us in any way, so we remain the gold standard."

And in terms of marketing, he said, "We're going to continue doing what we've been doing," such as sponsoring a car in NASCAR races and getting endorsements from the likes of soccer star Pele.

Pfizer has worked hard to bring impotence out of the closet, and Levitra's makers, too, talk about reducing stigma and prompting men to seek treatment. "The real opportunity here is to expand the marketplace," Bryan said.

Of the estimated 30 million American men with erectile dysfunction, only about one-tenth use Viagra.

But in Europe, where all three drugs are on sale, initial indications are that Levitra and Cialis do pull consumers away from Viagra and don't bring in new patients for treatment as quickly as hoped.

Sales of the new drugs "are eating away at Viagra's sales, and unfortunately, the broadening of the market that everyone expected is happening at a slower pace than they want," Goldstein said.

His center has performed clinical trials on all three of the drugs, and received money for the tests from all the drug companies. He said Levitra, whose chemical name is vardenafil, does a better job than Viagra biochemically at blocking the enzyme. It also has the advantage of not needing to be taken on an empty stomach.

For its part, Cialis does have the advantage of lasting a day and a half, compared with about 12 hours for Viagra and about 15 to 18 for Levitra, he said.

Carole Copeland, a spokeswoman for the joint venture between Eli Lilly and a biotech company called ICOS, which are working together on Cialis, said: "It offers a longer window of opportunity for intimacy, and that's what men and their partners say they miss most when they have erectile dysfunction: those special moments that just come naturally."

Ultimately, Goldstein said, each of the impotence drugs could find its own niche.

It could be that some patients will be swayed by actor Paul Newman's connection to Cialis, he said, or Ditka's role in the Levitra campaign. Or it could be that the same person will use Levitra or Viagra during the week and Cialis on Friday night.

"I think choice will be the inevitable consequence, and that has to be good," he said.

Carey Goldberg can be reached at Goldberg@globe.com.