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Jumping into competition against the universally known Viagra, the marketers of Cialis pushed the limit with their ads for their erectile dysfunction drug -- they were more direct than their competitor about its actual impact on sexual function and then threw in a little romance.

It was a risky strategy for Eli Lilly and Co., the U.S. pharmaceutical giant, and its partner, ICOS Corp. of Bothell, Wash., which developed the drug. It was also hugely successful and exactly what was needed in a market that has unexpectedly begun to go soft.

The drug industry may have overestimated the size of this market and sales growth has levelled off after a few years of boom times. And, as competition increases for a pie that is no longer growing much, advertising strategy looms large.

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For Cialis, the romance pitch is centred on the spontaneity made possible by a pill that offers erection assistance for a full 36 hours, nine times that offered by its two rival products, including market leader Viagra, made by Pfizer Inc. The risky part came in because of U.S. advertising guidelines that forced the firm to prominently disclose the drug's potential adverse effects -- including dangerous four-hour erections -- alongside its attributes.

Up until Cialis broke new ground, ads for erectile dysfunction (ED) drugs had restricted themselves to simple images of happy, vital men. TV spots might show them throwing footballs through tire swings, or dancing down an early morning residential street in slow motion.

A reference to the drug name at the end of the ad was the only way viewers could associate the exuberance with a postcoital glow. It was left up to viewers to contact their doctors to get more information.

Lily-ICOS, on the other hand, served up ads for Cialis with a soft, relaxed focus on couples and romantic settings. The message was that the drug's effects would be there "when the time was right."

But the major TV spot, which ran for the second straight year on the Super Bowl telecast in the United States last month, came with a decidedly unromantic kicker: It ends with a product warning of possible headaches, back aches, upset stomachs and, in extremely rare cases, four-hour erections requiring a visit to the hospital emergency room.

The marketing front is assuming a huge significance in the battle of ED drug makers. For a while, the market was growing so fast, it was enough to get your name out there in front of the public. But the market seemed to mature faster than expected, and sales growth wasn't helped by drug companies giving away complementary samples through doctors.

Seven years after Pfizer sparked a sexual revolution for aging men with its "little blue pill," growth in the market for ED drugs is flagging. Three competing companies are now battling fiercely for a share of a pie that until recently was expected to grow exponentially and provide handsome profits to all entrants.

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Last year, the three companies, Lilly-ICOS, Pfizer and a partnership led by GlaxoSmithKline PLC spent a stunning $373.1-million (U.S.) in direct-to-consumer advertising, which inundated fans of NFL football, Major League baseball, PGA golf, and NASCAR racing. The upshot of the ads was men had pharmacological help for any decline in sexual potency that they might be suffering. At least as much was spent on marketing to urologists and other doctors.

Yet, the prime U.S. market grew only 8 per cent last year. Globally, ED drugs sales today are about $2.1-billion (U.S.), but just a few years ago industry analysts were projected sales would be nearing levels about three times that.

Of the three, Lilly-ICOS appears to have momentum: and the marketing strategy is a major reason, the company says. By the end of its first full year, it had managed to grab 20 per cent of the market from the universally known Viagra and took nearly double the share of GlaxoSmithKline's Levitra.

Lilly-ICOS launched its product in the United States in November, 2003, and was the last to enter the fray in the world's biggest market. Leonard Blum, marketing vice-president for ICOS and a member of the Lilly-ICOS board, credits Cialis's success so far in the U.S. market to the ad campaign.

The major challenge was to somehow set the drug apart from Viagra in the minds of consumers. Since launching Viagra in 1998, Pfizer had been airing "awareness ads," avoiding any description of the exact benefits the little blue pill offered.

The makers of Levitra followed that strategy, using macho pitchmen, such as former Chicago Bears coach Mike Ditka and former Dallas Cowboys running back Anthony Dorsett, to talk about erectile dysfunction and encourage men to seek medical help.

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Mr. Blum and his colleagues on the Lilly-ICOS marketing team watched intently as Levitra failed to make large inroads. They seized on the major difference between the drugs: Cialis remains active in the body for 36 hours, while Viagra and Levitra have a four-hour limit.

"Cialis is fundamentally different from Viagra because it creates a very different experience for the man with ED and his partner," Mr. Blum explained in an interview.

"It allows the couple to enjoy the romance, to respond when the time is right. When you have something that only works for a few hours, it leads to a paradigm where everything revolves around planning pressure and the sexual act."

In meetings in Washington and Indianapolis that fall, the joint venture team plotted its campaign and monitored focus groups that were tested on the 36-hour difference. Mr. Blum and his colleagues were elated with the positive feedback.

Then in January, 2004, with just weeks to go before the Super Bowl ad launch, the U.S. Food and Drug Administration threw a wicked curve that tested the Lilly-ICOS team's resolve; the FDA wanted a more extensive list of possible side effects included. Cautionary words have become commonplace in drug advertising but in Cialis's case, the FDA insisted an explicit warning of the slight risk of priapism -- the medical term for an abnormally persistent erection that requires medical attention.

Mr. Blum was frustrated by the last-minute demand -- Cialis patients had never experienced priapism during years of clinical trials (although some Viagra patients had), and the new language would require approval from CBS, which was broadcasting the game. By the time he got the okay from the network and the FDA on wording, he had just a few days to get the ads ready for the big game.

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The Lilly-ICOS strategy runs counter to the perceived wisdom in the pharmaceutical industry about the value of direct-to-consumer advertising. In following it, Marta Wasinska, a marketing professor at Harvard Business School, says the companies were playing with fire.

In a study to be published in the Journal of Marketing Research, Ms. Wasinska found that "full indication" advertising can reduce demand for certain drugs by raising inflated fears of the side effects.

"I know companies are wary about having to present that information because people are very bad at interpreting this kind of information. People are really bad at interpreting risk."

The Cialis ad certainly provoked a tempest. Water-cooler comics and their professional late-night counterparts seized on the "four-hour erection" for new material, while parents and moralists objected to the "E" word appearing on a family-oriented broadcast. Fortunately for Lilly-ICOS, its risqué spot was overshadowed by Janet Jackson's half-time "wardrobe malfunction."

Mr. Blum said response of the wider public was immaterial; research showed the ads scored with its silent target audience. According to NDCHealth, a health care information company, Cialis sales soared nearly 250 per cent last February and March, from $4.5-million in January to $11-million in March.

Still, the Lilly-ICOS management team remained skittish about generating more controversy. It was prepared to skip this year's Super Bowl until a team of experts recommended in November that they go back to the well. "They said: 'You guys are crazy [for considering dropping it] If something worked well for you, you've got to do it again,' " Mr. Blum recalls.

Levitra -- which is stuck at low double-digits in market share -- appears to be hitting the brakes the hardest. Last month, GlaxoSmithKline announced it was selling its share of marketing rights outside the United States back to its partner Bayer AG of Germany, while Shering-Plough Corp. acquired Bayer's Levitra rights in the United States.

Pfizer, which was outspent by more than 50 per cent last year by both its new competitors, said it will continue to defend its market share. Pfizer spokesman Daniel Watts said Viagra's market share appears to have stabilized and perhaps even rebounded a bit in early 2005.

While companies engage in a public battle in the United States, in Canada and most European countries, they can only do consumer advertising that talks about the medical condition and recommends patients see their doctors.

Lilly-ICOS is running generic, less explicit ads on CBC, CTV, TSN and French-language RDI, said Norma Piggot, the company's director of marketing in Canada. She estimated that three million Canadian men suffer from erectile dysfunction and only a small fraction of them are being treated for it.

Lily-ICOS's Mr. Blum confirmed that the company will be spending "significantly less" on marketing this year than it did in 2004.

As a group, ED drug makers now face a tough choice. There remains a huge untapped market: An estimated 152 million men worldwide suffer from erectile dysfunction. Company executives estimate that no more than 20 per cent of those sufferers have actually sought treatment but acknowledge that men appear to be stubbornly resistant to their marketing efforts.

Given that resistance, the companies now have to decide how much to continue to gamble on expensive advertising and other marketing efforts.

Battle for the bedroom

Seven years after Pfizer sparked a sexual revolution for aging men with its 'little blue pill,' three companies are now battling for a share of the $2.1-billion (U.S.) global market for drugs aimed at correcting erectile dysfunction. Pfizer's Viagra is still the big man on the market, but Lilly-ICOS is nipping at its share with a marketing campaign that promotes the longevity of its Cialis. Meanwhile, Levitra, put out by GlaxoSmithKline and Shering-Plugh, seems to be fading.

Levitra

Company: Glaxo SmithKline PLC and Bayer AG. U.S. marketing rights, GlaxoSmithKline and Shering-Plough Corp., non-U.S. marketing rights, Bayer.

Launched: August, 2003

Sales*

2004 worldwide: $265-million

2003 worldwide: $200-million

2004 U.S.: $135-million

2003 U.S.: $28.5-million

Share of U.S. prescriptions

February 2004: 9.4%

July 2004: 10.2%

January 2005: 10.8%

Market share: 13% worldwide

Pitchmen: Former Chicago Bears coach Mike Ditka; former Dallas Cowboys running back Anthony Dorsett.

Marketing: Generic TV ads, detailing to doctors that it promises fewer side effects than Viagra; quicker effect than Cialis.

Free samples: 40% of U.S. patients

Advertising spending: $140-million* in the U.S. (2004)

*****

Viagra

Company: Pfizer Inc.

Launched: 1998

Sales*

2004 worldwide: $1.67-billion

2003 worldwide: 1.8-billion

2004 U.S.: $886-million

2003 U.S.: $1.1-billion

Share of U.S. prescriptions

February 2004: 83%

July 2004: 74%

January 2005: 68%

Market share: 67% worldwide

Pitchmen: Former senator Bob Dole; Nascar drive Mark Martin; "Wild Thing," an anonymous, middle-aged man who sprouts horns at the sight of a bikini-clad mannequin.

Marketing: Generic, erectile dysfunction TV ads, heavy "detailing" with urologists and other doctors.

Free samples: 29% of U.S. patients

Advertising spending: $84.5-million* in the U.S. (2004)

*****

Cialis

Company: Lilly-ICOS, a joint venture between Eli Lilly co. and ICOS Inc.

Launched: November, 2003

Sales*

2004 worldwide: $552-million (U.S.)

2003 worldwide: $203-million

2004 U.S.: $206.6-million

2003 U.S.: $2.9-million

Share of U.S. prescriptions

February 2004: 7.5%

July 2004: 15.8%

January 2005: 21%

Market share: 20% worldwide

Pitchmen: None, Cialis focuses its advertising on couples.

Marketing: TV ads highlight 36-hour effectiveness - "Cialis promise" that offers existing users free sample of any of the three brands.

Free samples: 35% of U.S. patients

Advertising spending: $148.6-million* in the U.S. (2004)

*U.S. dollars

SOURCE: COMPANY REPORTS, NDCHEALTH; NIELSEN MONITOR-PLUS

$2.1 BILLION

ANNUAL GLOBAL SALES FOR ERECTILE DYSFUNCTION DRUGS, ABOUT ONE-THIRD OF FORECASTS A FEW YEARS AGO

$149 MILLION

2004 U.S. MARKETING COSTS FOR LIVITRA, WHICH RECORDED SALES TOTALLING $135-MILLION

250%

AMOUNT OF SURGE IN CIALIS SALES IN TWO MONTHS AFTER FIRST CONTROVERSIAL SUPER BOWL AD APPEARED

$373 MILLION

2004 MARKETING BUDGET FOR BIG THREE PLAYERS IN ERECTILE DYSFUNCTION DRUG MARKET

36 HOURS

HOW LONG CIALIS REMAINS NI THE BLOODSTREAM, COMPARED WITH FOUR FOR VIAGRA AND LEVITRA

152 MILLION

NUMBER OF MEN WORLDWIDE ESTIMATED TO SUFFER FROM ERECTILE DYSFUNCTION

All figures in U.S. dollars

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