Cialis & Other ED Rx Drugs Face Challengers

[Pharma Newshound]

Soucre: IndyStar

Lilly's Cialis meets with success, challenges

Lilly made a splash with controversial TV spots first aired during the 2004 Super Bowl. The drug's demand and profits have since soared, but challenges remain on the horizon.

By John Russell
john.russell@indystar.com

It was a Super Bowl commercial that raised eyebrows around the country.

Six years ago, Eli Lilly and Co. introduced its new erectile-dysfunction drug to a national audience with a 60-second spot that showed middle-aged and elderly couples snuggling and flirting, and relaxing in side-by-side bathtubs at sunset. A voiceover said: "Cialis. Are you ready?"

Then, in a line that would be the parodied by late-night comedians, the announcer rattled off a long list of possible side effects, including erections lasting longer than four hours.

The commercial generated a flood of complaints, many from parents who called the topic inappropriate for a show viewed by millions of children.

Despite the complaints, Cialis quickly became a household name, and demand remains so strong that Indianapolis-based Lilly has been able to double the price of the drug since its launch in 2003, to about $16 a pill. Last year alone, during a recession, Lilly increased the price of Cialis twice. Competitors, including Pfizer (maker of Viagra) and GlaxoSmithKline (maker of Levitra), also raised prices.

But now Lilly faces new challenges to keep sales robust. Several other companies are developing new ED drugs, and some analysts think at least one will hit the market this year or next. Meanwhile, Viagra will lose its patent exclusivity in 2012, which will allow competitors to introduce low-priced generic versions. Such a move could pull down prices for the entire category, some analysts say.

The challenges will require Lilly to respond by finding new ways to promote Cialis' distinctive features, without offending some people who find the subject not fit for polite conversation.

At the same time, it has to keep the message light and even entertaining, for fear of being lost in the commercial din. Already, Cialis is one the top drugs in the nation in terms of money spent on direct-to-consumer advertising.

"At a certain point, advertising reaches a point of declining returns, and you've lost your audience," said Les Funtleyder, a drug analyst at Miller Tabak & Co. in New York. "I think by now, most people know what Cialis is and what it does."

It wasn't always so. Viagra, the pioneer in ED drugs, hit the market five years before Cialis. Lilly had to come up with a bold way to grab the spotlight. It did so with the Super Bowl commercial in 2004.

Where Viagra had been a bit timid and clinical, using former Sen. Bob Dole as a celebrity pitchman to talk about his medical issues, Cialis got right down to business. It showed couples in playful settings, nuzzling and hugging. The New York Times described the original commercial's tone as "frisky" and "devil may care."

But plenty of people thought the commercials went over the top. Thousands of people complained, lighting up phones at Lilly, the network and the National Football League.

Nevertheless, a year later, Lilly rolled out another version of the commercial, with the same light touch, with the upbeat music of the Ronettes' 1960s hit song "Be My Baby" in the background.

But that was the last year for Cialis at the Super Bowl, and Lilly is taking a pass during today's game as well -- for "strategic reasons," said company spokeswoman Keri McGrath, declining to elaborate.

That doesn't mean Cialis is going into hiding. Lilly has spent hundreds of millions of dollars to advertise the drug on other shows, from golf tournaments to late-night shows. It is even preparing to launch a new commercial for Cialis later this month.

Over the years, the ads have continued to generate sporadic complaints. In 2006, Barack Obama, then a U.S. senator, described himself as "a parent who has had to sit through uncomfortable Cialis commercials while watching television with my 7- and 4-year-old daughters."

The Parents Television Council, a socially conservative lobby, also has complained numerous times, although lately it has backed off. Last year, a council representative showed up at Lilly's annual shareholder meeting to congratulate management for not airing Cialis commercials during children's programming or prime-time hours. John Lechleiter, Lilly's chairman and chief executive, thanked the representative for holding the company accountable.

Love them or hate them, the Cialis bathtubs are hard to forget.

According to an analysis by the Nielsen Co., the Cialis bathtub ads are among the most recalled drug and vaccine ads shown on television.

One of the Cialis ads, featuring a middle-aged couple cuddling on the couch -- whose special moment is interrupted by a daughter returning from college for a visit -- was named the No. 1 most-recalled drug ad of 2008.

Cialis ads apparently are reaching the target audience. Lilly says the typical patient is a middle-aged man who wants to remain sexually active but is embarrassed by ED and wants to hear it's a common medical problem he can discuss with his doctor.

"I think there's good marketing logic for TV ads in this product category," said Anthony Cox, professor of marketing at Indiana University's Kelley School of Business in Indianapolis. "This is a doorknob moment kind of product, where the patient is about to leave the doctor's office but then says, can you help me with one other thing?"

Competitors are starting to crowd into the landscape.

Warner Chilcott has an ED drug, known as Zydena, in late-stage clinical testing. The company licensed the drug from Korean company Dong-A Pharmaceutical, which has already launched the drug in many Asian countries. Today, it is one of Korea's best-selling drugs.

California startup Vivus Inc. is developing an ED drug that it says works in 30 minutes or less -- faster, it claims, than Cialis or Viagra, which take two hours and one hour, respectively, to work. But Lilly disputes that Cialis takes two hours to work. Cialis often works in 30 minutes or less, and company materials referring to two hours mean the time for maximum concentration of the drug in the bloodstream, not the efficacy of the drug, Lilly said.

And who knows how long Lilly can continue to raise prices, particular after Viagra goes generic in two years?

"Whenever a drug in any class goes generic, you usually see a shift by consumers and insurers to the cheaper versions," said Funtleyder, the drug analyst. "I expect that to happen with ED drugs, too."

On top of that, drug makers are finding it tougher to get insurers to cover ED drugs, which a large swath of society still views as a lifestyle drug. The majority of government plans don't cover ED drugs. Some private plans don't cover them, either.

Yet Cialis has its selling points. It remains the only ED drug that works for 36 hours, rather than wearing off in just a few hours, so there's less pressure for men to watch the clock. "When the moment is right, you can be ready," goes the familiar Cialis motto.

And Cialis is the only ED drug with a lower-dose, once-a-day version, designed for men who anticipate having sex two or more times a week without confining it to a limited time.

Sex remains a robust market, even in a down economy. Watch for Lilly to fill up its bathtubs again.
Additional Facts
Cialis at a glance

• Launched: 2003, five years after competitor Pfizer introduced Viagra.
• Super Bowl commercials: 2004 and 2005.
• Purpose: Treats erectile dysfunction, which affects up to 30 million men in the U.S.
• Maker: Eli Lilly and Co.
• Versions: Standard version is 10 or 20 mg, which is taken occasionally and is good for 36 hours. A newer, 5 mg, once-a-day version is for men who expect to have sex twice or more a week and want to be constantly ready.
• Sales: $1.6 billion in 2009, up 8 percent from a year earlier.
• Patent expires: 2017.

Sources: Eli Lilly and Co., Star research