Is Viagra Vulnerable?

Paula Garrett knew she had a winner a year ago. The marketing executive for Eli Lilly & Co. (LLY ) was gauging consumer reaction to a yet-to-be released drug aimed at treating erectile dysfunction. The lights went back on in a conference room where three women had been viewing a prospective TV commercial for the drug, which Lilly had dubbed Cialis. The focus-group members, whose husbands all suffered from impotence, had watched attentively as a male voice-over gently advised: "Introducing Cialis. You can take Cialis anytime and have up to 36 hours to respond to your partner, without planning or rushing." As Garrett observed from the other side of a one-way mirror, the group's moderator tried to suss out the main source of the women's interest. "Tell me specifically," she asked. "What is it you like about Cialis?"

Suddenly, one of the women leaped out of her chair. She was about 60 years old and seemed as straitlaced as a Sunday school teacher. "Thirty-six hours!" she whooped, raising her arms like she was doing the wave at a ballgame. "Yeah!"

Garrett recalls laughing with delight. In her 15-year career in brand marketing, she has monitored hundreds of focus groups, for Procter & Gamble (PG ), Coca-Cola (KO ), and, since early 2001, Lilly as U.S. consumer marketing manager for Cialis. Yet she says she can't recall ever seeing anyone get this excited about a product. "It was a marketer's dream," she says.

Just how good a dream Lilly will discover soon. Sometime in the next several weeks, Lilly and its joint-venture partner, biotech lab ICOS Corp. expect to get final approval from the Food & Drug Administration to sell their Viagra slayer, Cialis, in the U.S. An ad campaign expected to cost at least $100 million in its first year would follow within days. There's a lot riding on Lilly's ability to turn Cialis (the name is derived from the French "ciel ," or sky) into a billion-dollar drug. Lacking any new hits since Prozac lost its patent protection in mid-2001, the Indianapolis drugmaker expects its earnings to drop in 2003 for the third year in a row, to no more than $2.66 billion. And it is eager to turn around a stock that has sagged 21% over the past two years, to $63 a share.

The launch also will be the first test of whether Lilly, which has never attempted a mass direct-to-consumers campaign in the past, has mastered the marketing skills needed to compete in today's hypercompetitive drug market. The challenge for drugmakers is not much different from that confronting marketers of breakfast cereal, detergent, or soft drinks: Take a product that is fairly similar to those of rivals and find some point of difference that is meaningful -- or can be made to seem meaningful -- to potential buyers. In this case, the edge is that Cialis lasts for up to a day and a half, while competing brands are potent for only four hours.

Lilly executives, of course, believe they have succeeded, which is why they were willing to give BusinessWeek a peek at how they crafted the marketing plan for Cialis. They've been buoyed by the drug's initial success in Europe, Saudi Arabia, Brazil, and other markets. It had first-half sales of $58.9 million, passing Viagra for wholesale pharmacy orders in France and Italy. Analyst C. Anthony Butler of Lehman Brothers Inc. expects global sales for Cialis to hit $300 million in 2004 and as much as $2 billion six years out. Declares Lilly Chairman and CEO Sidney Taurel: "It's a blockbuster drug."

To get there, Lilly must best some ferocious competition. Already, rivals are suggesting to doctors that while Cialis may last longer, it also prolongs the nasty side effects that some users experience with impotence drugs -- headaches, muscle aches, and nausea. The world's No. 1 drugmaker, Pfizer Inc. (PFE ), proved its marketing mastery with the first ads for Viagra in 1998. That campaign, built around testimonials by Bob Dole appealing mostly to older men, took the problem of erectile dysfunction out of the realm of the taboo. Today, Viagra ranks with Coca-Cola among the most widely known consumer brands in the world, with sales approaching $2 billion.

It's no wonder everyone knows Viagra -- Pfizer spent $87.3 million last year to advertise Viagra in the U.S. alone, says TNS Media Intelligence/CMR. And the market leader is ready to buy more TV time and ad pages to stay on top, says Janice Lipsky, Viagra's U.S. team leader. Concedes Leonard M. Blum, ICOS vice-president for sales and marketing: "There aren't many examples in our industry of products launched in second or third position that end up becoming the leader. It's a tall order."

Adding to Lilly's challenge, Cialis has been beaten to the U.S. market by Levitra, which is being pushed by a 50-50 partnership of GlaxoSmithKline PLC (GSK ), the industry's No. 2 player, and Bayer. Employing TV ads that promise the virility of a professional athlete, those companies have redefined erectile-dysfunction pills into something approaching a lifestyle drug. Already, after just two months of marketing, doctors say many men are asking specifically for Levitra. The drug grabbed 13% of new erectile-dysfunction prescriptions in September, according to market researcher IMS Health Inc.

Stepping into this brawl, Lilly executives knew they could leave nothing to chance. The Cialis campaign got started in mid-2000, a full year before large-scale clinical testing of the drug had even been completed. Lilly embarked on a monumental research effort, parsing reams of market data and quizzing thousands of men suffering from impotence and their partners. The data pointed to some significant opportunities. While Pfizer's marketing juggernaut had persuaded more than 16 million American men to try Viagra, that was barely half the estimated 30 million who suffer at least some sexual dysfunction. Reach those other 14 million, it was clear, and you could develop a substantial business even if you didn't steal a single user from Viagra.

There was more. Of those 16 million men who had tried Viagra, more than half hadn't renewed their prescriptions. That's a much higher dropout rate than with most drugs. To Garrett's marketing team, that suggested that Viagra was indeed vulnerable.

Meanwhile, an intriguing development was emerging from the lab. While Cialis, Viagra, and Levitra all work on the same principle -- they are so-called PDE5 inhibitors, which make muscles in the penis relax and allow increased blood flow for an erection -- some crucial differences were showing up in clinical trials. For one, unlike Viagra, Cialis remained effective even if the user ate or had a drink. That provided an edge, albeit a modest one, because Levitra offered the same advantage. More promising was that while both Viagra and Levitra enabled men to have an erection anytime from a half-hour to 4 hours after swallowing the pill, Cialis expanded that window to 36 hours. Would consumers perceive that to be a valuable benefit to their mating rituals? The answer seemed clear enough from the reaction of focus-group participants.

With a promising point of difference uncovered, the next challenge was how to communicate it to consumers amid the marketing din emanating from Viagra and Levitra. From their very first sessions with patients, Lilly's market researchers detected sharp differences in the way men perceived Cialis and Viagra. In one-on-one interviews in mid-2000, Viagra users who had been informed of the attributes of both drugs were given a stack of objects and asked to sort them into two groups, one for Viagra and the other for Cialis. Red-lace teddies, stiletto-heeled shoes, and champagne glasses were assigned to Viagra, while fluffy bathrobes and down pillows belonged to Cialis. The implication: Viagra was for studs, Cialis for romantics.

The dichotomy was reinforced in one-on-one sessions with partners of men with impotence problems. With Viagra, women often confessed, they felt under the gun to perform. "It feels like there are three of us in bed," marketing manager Garrett recalls one saying. "Me, him, and the pill." On the other hand, women typically said that from what they had heard about Cialis, they could be more natural and wait to have sex until both of them were in the mood. With each session, Garrett and her colleagues grew surer that they had a message consumers would warm to.

Following hundreds of patient and partner interviews, focus groups, and polling, Lilly and its ad agency, Grey Worldwide, got down to devising advertising strategies. Given a real product difference to flog, none of the approaches took the celebrity-spokesman route. "What we want is just to lay the facts on the table, because the facts are very friendly in our case," says Lilly's U.S. team leader for Cialis, Matthew W. Beebe. Agency and client eventually narrowed the proposals down to three and produced TV spots for each in early 2002. Two were variations on the theme, "Choose the moment." The third was based on the old hit song by The Supremes, You Can't Hurry Love .

After further consumer research, though, You Can't Hurry Love was rejected. By tying Cialis to one song, Lilly's market researchers concluded, they would never be able to alter the pitch even after consumers got tired of it. Instead, they opted for an ad with scenes of couples snuggling and slowly caressing, to emphasize cozy, tender, or playful moments. A soundtrack of easy, laid-back jazz seemed to work best. Garrett's final tweak was to lengthen scenes in the ad so the camera now seems to linger with each couple, a subtle reminder that with Cialis there's no hurry. The tagline: "When a tender moment turns into the right moment, you'll be ready." The spots will saturate prime-time shows and weekend sportscasts almost as soon as FDA approval is obtained. "You won't be able to turn on your TV without seeing ads," says ICOS' Blum.

But as Lilly waits, its rivals are not standing still. They're ratcheting up their own spending even as their thousands of sales reps work hard to derail Cialis' strategy. The reps are warning doctors -- often while sharing expensive meals paid for by the reps -- that while Cialis may be potent for as long as 36 hours, the drug's side effects might last that long, too. They also insist their own research shows that most men with impotence know well ahead of time when they might have sex, so the four hours that Viagra or Levitra provides them is usually sufficient.

Some doctors, such as Steven J. De Angeles, are proving receptive to the counterattack. "You could have 36 hours of misery," says the Chicago internist, whose office staff has been taken out to lunches costing more than $3,000 apiece by teams hawking Viagra and Levitra. Besides, he adds, unless they're going bar-hopping, men generally don't need that much time. De Angeles says he was won over by the marketers' arguments, not the gratis wining and dining. Lilly and ICOS hint that they'll use similar tactics to reach doctors once Cialis is approved.

Of course, from Lilly's perspective, any resistance from doctors makes it even more important that its ad campaign capture the attention of consumers. Company executives are confident that their message will cut through the clutter, proving that Lilly belongs with Pfizer and GlaxoSmithKline in the ranks of adept consumer marketers. If they're right, consumers won't be the only ones whooping it up. Lilly's shareholders will have a reason to do the wave, too.

Corrections and Clarifications In "Is Viagra vulnerable?", Dr. Steven J. De Angeles was quoted as saying his staff had been taken out to lunches worth more than $3,000 apiece by sales reps from Pfizer Inc. and a partnership of GlaxoSmithKline PLC and Bayer. The lunch tabs were actually as much as $300.

By Michael Arndt in Indianapolis

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• I-75 to 696 east to go to the Hoover/Schoenner exit. There is not a specific exit for Schoenner.
• Go about two miles then turn right on Schoenner. Chicken Shack on corner.
• Go one block to Champagne and make a right.
• Go one block to Burgundy and make a left.
• Go to the end of the block on the left hand side look for 13038 Burgundy.
• Go through side door and down the stairs to the studio. (Blue light above the door) It is a residential block.

• 1-94 and head east
• Next turn 696 heading west for one mile.
• Get off of on the Groesbeck exit and go for about two miles until you see Schoenner. (gas station on the corner)
• Make a left over the freeway.
• Go to Champagne one block past freeway on the right. Make a right.
• Go one block to Burgundy and make a left. Go to the end of the block on the left hand side look for 13038.
• Go through side door and down the stairs to the studio.
• There is a blue light above the door. It is a residential block.

From West Side – Livonia/Ann Arbor/….

• I 96 to 94 east
• Next turn 696 heading west for one mile.
• Get off of on the Groesbeck exit and go for about two miles until you see Schoenner. (gas station on the corner)
• Make a left over the freeway.
• Go to Champagne one block past freeway on the right. Make a right.
• Go one block to Burgundy and make a left.
• Go to the end of the block on the left hand side look for 13038.
• Go through side door and down the stairs to the studio.
• There is a blue light above the door. It is a residential block.

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What is Cialis (tadalafil)?

Cialis (tadalafil) relaxes muscles and increases blood flow to particular areas of the body.
Cialis (tadalafil) is used to treat erectile dysfunction (impotence).
Cialis (tadalafil) may also be used for purposes other than those listed in this medication guide.

What should I discuss with my doctor before taking Cialis (tadalafil)?

Do not take Cialis (tadalafil) if you are also using a nitrate drug for chest pain or heart problems. This includes nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, and others), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), and isosorbide mononitrate (Imdur, ISMO, Monoket). Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite ("poppers"). Taking tadalafil with a nitrate medicine can cause a serious decrease in blood pressure, leading to fainting, stroke, or heart attack.

A small number of patients have had a sudden loss of eyesight after taking tadalafil. This type of vision loss is caused by decreased blood flow to the optic nerve of the eye. It is not clear whether tadalafil is the actual cause of such vision loss. Sudden vision loss with tadalafil use has occurred most often in people with heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoke or are over 50 years old.

Before taking Cialis (tadalafil), tell your doctor if you have:
heart disease or heart rhythm problems;
a recent history of heart attack (within the past 90 days);
a recent history of stroke or congestive heart failure (within the past 6 months);
angina (chest pain);
high or low blood pressure;
liver disease;
kidney disease (or if you are on dialysis);
a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia;
a bleeding disorder such as hemophilia;
a stomach ulcer;
retinitis pigmentosa (an inherited condition of the eye);
a physical deformity of the penis (such as Peyronie's disease); or
if you have been told you should not have sexual intercourse for health reasons.

If you have any of these conditions, you may not be able to use tadalafil or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category B: Although tadalafil is not for use in women, this medication is not expected to be harmful to an unborn baby. Do not use tadalafil without telling your doctor if you are pregnant or plan to become pregnant during treatment.
Although Cialis (tadalafil) is not for use in women, it is not known if tadalafil passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
You may need a lower dose of this medication if you are older than 65. Follow your doctor's instructions.

How should I take Cialis (tadalafil)?

Take each dose with a full glass of water.
Avoid taking High-fat food before taking Viagra as it may cause the medicine to take more time to start working.
Tadalafil is usually taken only when needed, 30 - 60 minutes before sexual activity. The medication can help achieve an erection when sexual stimulation occurs. An erection will not occur just by taking a pill.
Do not take tadalafil more than once a day. Allow 24 hours to pass between doses.
Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Since tadalafil is used as needed, you are not likely to be on a dosing schedule.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.
Symptoms of a tadalafil overdose may include chest pain, nausea, irregular heartbeat, and feeling light-headed or fainting.

What should I avoid while taking tadalafil?

Avoid drinking alcohol, which can increase some of the side effects of tadalafil.
Grapefruit and grapefruit juice may interact with tadalafil. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.
Do not use any other drug to treat impotence, such as alprostadil (Caverject, Muse, Edex) or yohimbine (Yocon, Yodoxin, others), unless your doctor tells you to.

What are the possible side effects of tadalafil?

If you become dizzy or nauseated, or have pain, numbness, or tingling in your chest, arms, neck, or jaw during sexual activity, stop and call your doctor right away. You could be having a serious side effect of tadalafil.
Stop using tadalafil and get emergency medical help if you have sudden vision loss.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using tadalafil and call your doctor at once if you have any of these serious side effects:
chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
irregular heartbeat;
swelling in your hands, ankles, or feet;
shortness of breath;
vision changes;
feeling light-headed, fainting; or
penis erection that is painful or lasts 4 hours or longer.
Continue taking tadalafil and talk with your doctor if you have any of these less serious side effects:
warmth or redness in your face, neck, or chest;
stuffy nose;
headache;
upset stomach; or
back pain.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
What drug(s) may interact with Cialis (tadalafil)?

Do not take tadalafil if you are taking the following medications:
nitroglycerin-type drugs for the heart or chest pain such as amyl nitrite, isosorbide dinitrate, isosorbide mononitrate, nitroglycerin, even if these are only taken occasionally

Cialis (tadalafil) may also interact with the following medications:
alpha blockers, such as alfuzosin (UroXatral), doxazosin (Cardura), prazosin (Minipress), or terazosin (Hytrin), used to treat high blood pressure or an enlarged prostate.
bosentan
certain antibiotics such as clarithromycin, erythromycin, troleandomycin
certain drugs used for seizures such as carbamazepine, phenytoin, and phenobarbital
cimetidine
cisapride
diltiazem
grapefruit juice
medicines for fungal infections (fluconazole, itraconazole, ketoconazole, voriconazole)
mibefradil
nicardipine
certain medicines for the treatment of HIV infection or AIDS
quinidine
rifabutin, rifampin or rifapentine
some drugs for treating depression, anxiety or other mood problems (examples: fluoxetine, fluvoxamine, nefazodone)
verapamil