Two new Viagra rivals heading to U.S. market

LONDON -- Viagra, the little blue pill that has revolutionized the sex lives of millions of men, has two potential rivals knocking at the door of the big U.S. market.

One, called Cialis, is known as "Le Weekend" pill in France for its reputed long-lasting effect. The other, Levitra, prides itself as the choice for those who want more spontaneity because it works in as little as 15 minutes, less time than the hour Viagra requires.

The Food and Drug Administration approved Levitra on Tuesday, and the makers of Cialis, Eli Lilly & Co. and Icos Corp., expect approval later this year.

All three drugs are effective about 70 percent of the time, and the side effects -- headaches, nasal congestion and flushing -- are similar. They all work by increasing blood flow in the penis in response to sexual stimulation by blocking an enzyme called phosphodiesterase-5, or PDE-5.

Both new drugs went on the market in Europe this year. They apparently prompted more men to seek treatment, creating an expanded market, one that Viagra still easily dominates. However, analysts say it is too early to tell how much Viagra will be affected by the newcomers.

"With the exception of the U.K., in the European markets they like innovation, and when something new comes along they want to try it," said industry analyst Brian Benedetti of IMS Consulting in London. "Once the enthusiasm for the new drugs dies down we will see how it settles."

Benedetti believes the chances of Cialis or Levitra unseating Viagra as market leader are slim because, he says, the two products share more similarities with Viagra than differences, and Viagra is already a household name.

Britain-based GlaxoSmithKline and German-based Bayer AG, who make Levitra, acknowledge that Viagra's brand recognition is formidable.

"We've found, and I think Cialis has found, that Viagra is synonymous with erectile dysfunction. It's like Hoover and vacuum cleaners. That is what we're up against," said GlaxoSmithKline spokesman Geraint Thomas.

Viagra's sales hit $1.7 billion last year; the drug has been taken by about 20 million men worldwide. The U.S. market, a big target for the new drugs, accounted for just over $1 billion of Viagra's sales, or 60 percent of last year's total.

Some experts say the new pills, particularly Cialis, may offer patients a strong alternative. Cialis's longer lasting effect has formed a central part of its marketing campaign; Viagra can last up to five hours.

"I have had patients come back to me after trying Viagra saying that the time scale is a problem," said Dr. Clive Gingell, a consultant urologist at the Nuffield Hospital in Bristol, England, who conducted the earliest experiments with Viagra in 1994.

"They sometimes waste a tablet because they find it difficult to tie themselves down to sexual activity in a particular few hours and here Cialis can be important because of the flexibility," said Gingell, who has prescribed all three drugs for his patients.

"I found Levitra and Viagra to be very similar drugs. The efficacy is about the same, duration of effect is about the same, and the side-effect profile is about the same," he said.

"Because Cialis does not make the patient have to plan sexual activity so tightly I think that will be a particular advantage for its sales," he said.

The drugs come in different doses and are priced according to dose. Viagra is slightly more expensive than the two newer drugs.

Analysts predict that, rather than stealing market share from Viagra, much of the gains that Cialis and Levitra will make will be from expansion of the market for impotence treatment.

Erectile dysfunction is thought to be vastly undertreated. Experts estimate that about 90 percent of men with impotence problems never seek medical help. Campaigns for the new drugs are likely to increase awareness of the problem and bring more men to their doctors' offices, experts say.

The launch of the new drugs in Europe has already expanded the market for impotence pills there, analysts say. In many countries, demand has increased by about 25 percent in the six months Cialis and Levitra have been on the shelves. In Spain, the market for such treatment has expanded by as much as 66 percent.