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Monday, December 08, 2003 - Page updated at 03:02 P.M.

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Cialis, 36-hour impotence drug, to take on leader Viagra

By Luke Timmerman
Seattle Times business reporter

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The battle of impotence drugs
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Viagra rejuvenated the sex lives of millions of people. But there's one big gripe about it: Men and women don't like having to schedule sex within the pill's four-hour window of effectiveness.

"It takes planning. It really takes out the spontaneity," said Dr. Fred Govier, a urologist at Virginia Mason Medical Center in Seattle.

Many men who've taken Viagra are perfectly happy with the impotence medication. But the blue pill's limitations may have created a multibillion-dollar opportunity for a competing yellow pill and its creator, Bothell-based Icos.

Icos believes its product, Cialis, has that potential because it lasts up to 36 hours, works slightly faster than Viagra and has similar side effects.

The drug, already on sale in dozens of countries, is expected to win U.S. approval soon.

In its first nine months, Cialis has snapped up 25 to 30 percent of the impotence-drug market in key European countries, and more than 1 million men have tried it.

Many people struggle to pronounce it, (See-AL-iss), but the drug has already gotten a catchy nickname in Europe — "le weekend" pill.

Cialis is expected to receive Food and Drug Administration approval within weeks for sale in the United States, the most lucrative market for impotence drugs. If it sells here the way it has in Europe, it could be the second billion-dollar-a-year drug created by a Puget Sound-area biotechnology lab, after Immunex's Enbrel for treating rheumatoid arthritis.

Aggressive TV campaign

Whether it will prevail among consumers is anybody's guess. History is full of well-regarded products trumped by superior marketing — think Beta vs. VHS.

But Icos and partner Eli Lilly, which will handle manufacturing and much of the sales and marketing, promise an aggressive TV campaign.

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"The way nature works is that people don't schedule sexual intimacy. It occurs when the time is right," said Leonard Blum, a Merck veteran and now Icos vice president of sales and marketing.

Thousands of Viagra users have been run through focus groups during that drug's five years on the market. The research suggests loads of opportunity for rivals.

Half of the men in North America and Europe have some degree of impotence, and most haven't tried Viagra. More than half of the men who tried it didn't continue for various reasons: They didn't like planning sex, it cost too much or it didn't work as well as hoped.

Levitra, another new competitor, is trying to make its name on an ability to be undiminished by food, and to create what it calls a "higher quality" experience. But it works only a little longer than Viagra — four to five hours.

One 52-year-old contractor from West Seattle said he considered Viagra a godsend at first, but his feelings have evolved.

The man, who asked not to be named, said he'll take Viagra if he thinks the night has potential for romance. If sparks don't fly within four hours, he's wasted $10. But if he waits to take the pill until the mood seems right, he has to wait an hour for it to take effect — enough time to get absorbed in a movie, or for the mood to change.

Either way, sex just doesn't feel right on a schedule.

"I want spontaneity back," said the contractor. "When you plan things, there's an expectation that has to be met, and that puts a lot of pressure on women to perform once the man has taken the pill. It's more exciting to know I'm responding and she's responding when it just happens."

Other than the longer-lasting effect, Cialis does not represent a radically different molecule from Viagra or Levitra. All three drugs work the same way: getting in the way of an enzyme and allowing for increased blood flow to the penis during arousal.

All have similar side effects. All cost $8 to $10 a pill.

The main difference with Cialis is that its active chemical takes longer to break down in the bloodstream.

Dr. Abraham Morgentaler, a Harvard urologist who has been a paid consultant to the makers of all three drugs, believes Cialis could become dominant.

"I've had people say, '(Viagra) worked, but that's not my idea of sex,' " Morgentaler said. "The lack of spontaneity, and the requirement of planning, is one of the real obstacles for people. Levitra has the same problems. It limits your opportunities. But the idea with Cialis that you can take it on a Friday evening and be ready to go anytime until Sunday evening — that's incredible."

He's curious whether people will have sex more often with Cialis, or how sexual behavior might change if men took it every day. He doesn't think that's realistic, because at $10 a pill, it's too expensive.

"If men did that, there would be no planning whatsoever. Men could have sex whenever they want; they could take the drug daily, like a vitamin," Morgentaler said. "We do have the ability, if you really want to push this to the next level, to make things the way they used to be."

Urologists and sex therapists say they aren't sure whether restoring the ability to have sex anytime over the weekend will represent another major shift in people's sex lives or not.

Joy Davidson, a psychologist and certified sex therapist in Seattle, is skeptical of any claims to having the "Magic Bullet" for sexual dysfunction, because many people had those impossibly high expectations for Viagra.

Davidson sees the same stories come into her office over and over, sort of like this:

A man and woman think Viagra is the cure-all for a sexual relationship gone stale. The man takes the pill, and his performance anxiety is relieved. Sometimes, the woman is grateful, and the relationship develops more intimacy.

Other times, the man gains self-confidence and becomes fixated on erections and intercourse. The woman feels pressured and resents that her sexual pleasure or desire for romance has become secondary. The drug turns out to not be a panacea. Tensions arise.

'Viagratization'

Sex therapists see it so often, they have started calling the fixation on erections the "Viagratization of America."

Davidson said she can imagine Cialis allowing men and women to be more patient and relaxed with sex. Or, she said it could work the opposite way — worsening the problem by raising expectations of satisfaction sky-high.

"For women, in some cases Viagra is a detriment, because before when he wasn't able to have an erection, he may have been more attentive to other forms of foreplay that are more satisfying for the woman," Davidson said.

The makers of Viagra and Levitra have loaded their marketing budgets for a combined battle that is expected to top half a billion dollars in 2004.

Bayer and GlaxoSmithKline are pooling their resources to pitch Levitra. They hope their campaign, led by former football player and coach Mike Ditka, will also motivate average guys to see their doctor. They say that will determine whether their drug becomes a hit.

"We want to make it so that men feel they need to go to their doctor for this, like how they need to go to the doctor regularly if they need eyeglasses," said Nancy Bryan, vice president of marketing for Bayer.

Meanwhile, Viagra's distributor, Pfizer, considered the champion of pharmaceutical marketing, is bracing to defend Viagra, which generated $1.7 billion in sales worldwide last year.

Betting against defections

Pfizer is betting Viagra users are happy and will stick with it. The company says its research shows most people plan to have sex within a four-hour time frame and that Viagra is the only one with a five-year record of safety.

Janice Lipsky, Pfizer's U.S. team leader for Viagra, said the market has room for all three drugs and that the competitive crossfire could boost people's knowledge of them and be a windfall for all. Lipsky bristles at the notion that a longer-lasting drug might make a difference for couples. What will really determine the popularity of all the impotence drugs, she said, will be each drug's skill at motivating men to overcome their reticence and see their doctors.

"We know men are embarrassed about this. It's a sensitive topic, still, and it's private. Men tend to not share as much information with each other, versus women," Lipsky said. "A lot of what we do is to minimize the embarrassment and make men comfortable about going to the doctor. That's a lot of the psychology in this."

Luke Timmerman: 206-515-5644

Copyright © 2003 The Seattle Times Company

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