Eli Lilly and Co. to launch marketing campaign for diabetes drug

Eli Lilly and Co. to launch marketing campaign for diabetes drug

Indianapolis Star, The (KRT) via NewsEdge Corporation :

Sep. 19--First there was Cialis and the bathtub.

Then there was Cymbalta and the depressed woman on the couch who couldn't face the world.

Both drugs became blockbusters for Eli Lilly and Co., with help from a blizzard of memorable television and print ads, costing tens of millions of dollars.

Now get ready for Byetta.

This week, Lilly is launching its latest direct-to-consumer campaign in an effort to make Byetta a household word, following in the footsteps of Cialis, a sexual-dysfunction drug, and Cymbalta, an antidepressant.

Byetta is a drug for diabetics who do not yet need insulin injections. It will be featured in commercials during such shows as "60 Minutes," "CSI" and "Dancing with the Stars," as well as in prominent ads in Time, People and diabetes consumer publications.

Time magazine has Byetta ads in this week's issue. The TV commercials will begin Monday.

It's part of a wider push by the Indianapolis drug maker to regain its place in a competitive diabetes drug market it once dominated.

Diabetes, which affects about 20 million Americans, is the fifth-leading cause of death in the nation. But only a fraction of diabetics can take Byetta, which is for patients who do not yet need insulin injections. Still, Lilly said it sees a huge untapped market among the 8 million Americans who could use the product but don't.

Compared with some other Lilly campaigns, the kickoff spot for Byetta is gentle and low-key. There are no suggestive scenes, stark imagery or haunting music. The proposed 60-second spot features everyday people talking about their blood sugar, appetites and weight issues. They rave about Byetta's ability to help them manage their disease quickly.

"It helped me, starting Day One," says a middle-aged woman, sitting on her porch.

"Me, too, day after day," says a guy to another man as they sit in a car.

The simple message is designed to resonate with diabetics, who often spend hours a day trying to keep their blood sugar on an even keel.

"It's a full-time job for diabetics," said Paula Garrett, Lilly's director of consumer marketing. "They're thinking about all the things they can do and can't do, just trying to keep their blood sugar in control. People who have taken Byetta love the fact that it allows them to stay in control."

The drug has also found favor with diabetics for its weight-loss benefits.

Many diabetics who have gained weight on other medications say Byetta helped them shed pounds. The drug was so popular that Lilly had trouble meeting demand for a few months last year.

Lilly said it has no plans to market the drug as a weight-loss product for people with normal blood sugar.

"But any weight loss is a benefit to patients, because most current diabetes therapies have weight gain associated with them," said Dr. John Holcombe, a Lilly diabetes-care physician.

Lilly co-developed Byetta with San Diego-based Amylin Pharmaceuticals. The companies split revenues and profits.

Byetta demand remains brisk, with sales growing for at least the past six quarters. Sales last year, Byetta's first full year on the market, were $430.2 million.

But recently, the growth has slowed from three-digit percentage gains to two-digit percentage gains, and the market is becoming crowded with competing products.

Now, Lilly's goal is to create a louder buzz for a drug that has already been prescribed 3 million times to 600,000 patients since its launch two years ago.

Some analysts expect competition to get tougher, as other long-acting diabetes drugs appeal more to patients who hate the thought of injecting themselves twice a day, as Byetta requires.

Lilly doesn't have a long-acting diabetes drug, although several competitors do. The company is trying to develop a once-weekly formulation of Byetta.

"To go to the next level, Lilly needs a longer-acting version of Byetta," said Les Funtleyder, a drug analyst at Miller Tabak & Co. in New York. "One of the major pushbacks on this drug is the frequency of dosing."

Some other analysts agree.

"If you have a needle-phobic person that says, 'Now I can do it once a week, rather than twice a day,' you can get them to move to something that's injectable," said Leah Hartman, an analyst at CRT Capital Group in Stamford, Conn. "And that's a much bigger circle of patients likely willing to try it."

The diabetes market is extremely competitive and in flux. Earlier this summer, the Food and Drug Administration issued a safety alert on Avandia, an oral diabetes drug made by GlaxoSmithKline, after some clinical trials showed a "potentially significant increase" in the risk of heart attack and heart-related deaths in patients. Sales plummeted temporarily.

"Because of what happened with Avandia, I think Lilly senses an opportunity to pick up market share," said David Kliff, publisher of Diabetic Investor, a Chicago newsletter for investors in diabetes companies.

Some diabetes advocates say they are pleased that Lilly will be pushing the drug harder. Most diabetics are treated not by specialists but by primary care doctors, who are under time pressures and appreciate when patients research diabetes care on their own, said Kelly L. Close, principal of the San Francisco diabetes and obesity consulting firm Close Concerns.

"Companies like Lilly and Amylin are seeing that and are going directly to the diabetes patient to educate them directly," she said.

The FDA has approved Byetta for use in combination with oral diabetes drugs, not as a stand-alone treatment. Byetta stimulates the pancreas to produce insulin when blood sugar is high. The active ingredient is a synthetic version of a protein produced in the saliva of the Gila monster, a lizard of Mexico and the southwestern United States.

The advertising campaign is a dramatic turnaround for Lilly's diabetes group. Five years ago, the company cut its diabetes sales force dramatically, following a cash crunch after losing patent protection on its leading drug, the antidepressant Prozac. It saw its market share for insulin drop sharply.

But in the past two years, Lilly has pushed to rebuild its diabetes-care franchise, launching three new insulin pens, including one with a memory function of past doses. It donated $10 million to Riley Hospital for Children to help expand its diabetes facilities.

And it launched Byetta, which has won raves from patients and diabetes educators for its ability to control blood sugar quickly.

Lilly declined to say how much it is spending on the campaign, other than to acknowledge it will be on a scale similar to recent direct-to-consumer marketing campaigns for Cymbalta and Cialis.

According to Nielsen Monitor-Plus, Lilly and its partners spent $157 million on the Cymbalta campaign last year, making it the sixth most advertised drug in the nation. It spent $116 million on Cialis in 2005, making it the 10th most advertised drug that year, Nielsen said.

ABOUT BYETTA:

-- What: A twice-daily injectable drug to help diabetics control blood-sugar levels. It is for patients who do not yet need insulin.

-- Maker: Co-developed by Eli Lilly and Co. of Indianapolis and Amylin Pharmaceuticals of San Diego.

-- Inventor: The drug was discovered by Dr. John Eng, a researcher at the Bronx (N.Y.) Veterans Affairs Medical Center.

-- Launched: June 2005.

-- Sales: $430.2 million in 2006, with Lilly getting $219 million of the revenue.

-- Market: Byetta has been taken by 600,000 patients, with more than 3 million prescriptions written.

Source: Eli Lilly and Co.

DIABETES BY THE NUMBERS:

--In the United States, 20.8 million children and adults, or about 7 percent of the population, have diabetes.

--Of that number, nearly one-third are unaware they have the disease.

--Type 2 diabetes accounts for about 90 percent to 95 percent of all diagnosed cases of diabetes. It usually begins as insulin resistance, a disorder in which the cells do not use insulin properly.

--The U.S. market for Byetta is about 8 million diabetics who are Type 2 and do not yet need insulin injections.

Sources: American Diabetes Association, Centers for Disease Control and Prevention, Eli Lilly and Co.

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