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FDA OKs New Lilly Diabetes Drug

Posted on: Monday, 2 May 2005, 18:00 CDT

Apr. 30--A first-of-its-kind diabetes drug, derived from the saliva of the gila monster, will hit pharmacies by June 1.

The drug, approved with some limits by the Food and Drug Administration, treats people with type 2, or adult-onset, diabetes, the most common form of the blood-sugar disorder that affects 18 million Americans.

The injectable drug Byetta could became a major product for its developers, Eli Lilly and Co. of Indianapolis and Amylin Pharmaceuticals of San Diego, a small biotech firm whose top executives have Lilly ties.

Teams from both companies celebrated Friday after announcing the FDA approval, which wasn't as sweeping as it could have been.

The FDA approved Byetta for use in combination with oral diabetes drugs, not as a stand-alone treatment. The agency said Byetta appears to be "approvable" if given alone, but the companies would need to submit more data showing its effectiveness when used alone.

At Lilly, which helped commercialize insulin for diabetics in the 1920s, the Byetta approval helps solidify its long role as a leader in diabetes care. Lilly has been losing market share in the diabetes care market in recent years, as new rivals enter the business.

Byetta becomes the ninth drug Lilly has brought to market by itself or with partners since 2001. It's the most fruitful period ever for Lilly's research-and-development pipeline.

For publicly traded Amylin, the approval gives it its second product.

"This is the culmination of a very significant effort. We can't be more happy. We're going to have a party," said Amylin President Ginger L. Graham from Amylin's offices, where cheers could be heard over the phone.

The three-year partnership between Lilly and Amylin endured "some rocky roads" about two years ago, when disagreements arose between the two companies over how to proceed with the project, said Brian R. Cooley, brand team leader for Byetta.

But "we have a lot of confidence now we're ready to launch," he said.

Dr. John Holcombe, a Lilly medical fellow, said it helped to "see the relationship from your partner's eyes" and to talk about the value of the work they were doing.

"What really brought us together is when you put the patient in the middle of the table," he said.

Some investors were disappointed Friday the FDA didn't approve stand-alone therapy.

"We anticipate this more limited approval will dampen enthusiasm over the approval as investors reassess the likely kinetics of the launch," said Mike King, a stock analyst for Bank America Securities, in a report to investors.

Amylin's stock price fell $1.18 a share to $17 in trading Friday. Lilly stock rose 47 cents, to $58.47.

Byetta (pronounced By-A-tuh) is the first in a new class of "gut hormones." It works by stimulating the pancreas to produce natural insulin after meals.

The compound was synthesized from gila monster saliva. The big lizards have always been an intriguing subject of study by scientists looking for digestive and metabolic drugs, because gila monsters can go for months with little or no food.

Byetta enters an increasingly competitive market that includes a host of insulin sensitizers, such as Actos, another Lilly co-marketed product.

Byetta could generate $320 million in sales for Lilly by 2007, the investment firm Friedman, Billings, Ramsey & Co. estimated last year. In comparison, Actos had sales of $453 million last year.

Most diabetes pills help the body use its own insulin more effectively in controlling blood-sugar levels. But many users of the pills still find it difficult to keep their diabetes under control, and for them Byetta could bring a big improvement in health and allow them to delay taking insulin injections, said Dr. David M. Kendall, medical director for the International Diabetes Center, a not-for-profit diabetes clinic in Minneapolis.

Byetta "fills a unique niche between oral therapies and insulin" in treating patients with adult- onset diabetes, he said.

"I think it can be uniquely effective. I hate to say more... effective," said Kendall, who helped test the drug in clinical trials sponsored by Lilly and Amylin.

Diabetes is the fifth-deadliest disease in the nation. Of the 18 million Americans with the disorder, 5 million are undiagnosed, according to the American Diabetes Association. About 90 percent of those affected have type 2 diabetes.

The drug's commercial success may depend on how many users are willing to undergo the twice-daily injections. Byetta is injected with a fine needle mounted in a pen-type device made by Lilly.

Cooley called Byetta a "smart drug" that lowers blood sugar only when it's high.

"The fact that this has such unique benefits... makes it attractive to patients," even if they're needle-shy, he said.

The drug can't be put in pill form because it's a protein that would break down in the stomach.

Studies found that Byetta also seems to trigger a feeling of satiety in the brain, so users often eat less. The average patient in clinical trials lost 2 to 5.5 pounds over seven months.

Studies showed that patients using Byetta and diabetes pills had "clinically significant" improvements in control of their blood glucose, said Kendall. The gains tended to level off over time, Kendall said, but most patients who stopped taking Byetta lost the benefits.

Side effects included nausea and reduction in appetite.

Amylin licensed the compound in 1996 from its discoverer, Dr. John Eng, an endocrinologist at the Bronx (N.Y.) Veterans Affairs Medical Center.

In 2002, Lilly and Amylin agreed to work together to commercialize a synthetic version of the compound, which goes by the scientific name exenatide.

BYETTA FOR ADULT-ONSET DIABETES

--Use: Treats type 2 diabetes.

--How it works: Helps the body stimulate the pancreas to produce insulin after meals.

--Drug class: Incretin mimetics, which act much like a human hormone secreted in response to food intake.

--Discoverer: Dr. Joseph Eng, an endocrinologist for the Bronx (N.Y.) Veterans Affairs Medical Center.

--Developers: Amylin Pharmaceuticals, San Diego, and Eli Lilly and Co., Indianapolis.

--Origin: Derived from the saliva of the gila monster, a lizard native to Mexico and the southwestern United States.

--Production: Contract manufacturer will make the active ingredient. Lilly will package the drug in pen-type devices in Indianapolis.

--Sales potential: About $320 million in revenues to Lilly alone by 2007, according to one estimate.

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Source: The Indianapolis Star

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