Patients taking Eli Lilly & Co.'s experimental diabetes drug dulaglutide lost weight and had side effects that were manageable, the company said today after releasing more data from three final-stage clinical trials.
Lilly released top-line results from the company-sponsored trials last year, when it reported more patients taking the therapy had blood glucose levels indicating their disease was under control than those given Merck & Co.'s top-selling drug Januvia and Bristol-Myers Squibb Co.'s Byetta. The data released today had details of those results, as well as side effect and weight-loss information.
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"We look at the space and we feel we have an opportunity to offer a significant new product," said Sherry Martin, senior medical director for diabetes development at Indianapolis-based Lilly. The company plans to submit the drug to U.S. regulators for approval by the end of this year, she said. The studies were presented as part of the American Diabetes Association meeting in Chicago.
Lilly's drug, if approved, may be a significant competitor to Novo Nordisk A/S's Victoza, which generated $1.64 billion in 2012, according to data compiled by Bloomberg. A clinical trial comparing the drugs may report results by the end of the year.
"Dulaglutide data suggests a profile that may be sufficient to demonstrate superiority versus Victoza in the head-to-head study," said Sachin Jain, an analyst with Bank of America Corp. In a June 17 note to clients, he cut his rating on Novo shares to neutral from buy because of the Lilly data. The drug "represents a significant threat to Victoza market share," Jain said.
Merck, Bristol-Myers, and Johnson & Johnson also have competing diabetes therapies on the market. Dulaglutide is in a class known as GLP-1 receptor agonists. The injection mimics the function of a digestive hormone that stimulates the pancreas to produce insulin after meals.
The class of drugs, along with another group called DPP-4 that includes Januvia, are under scrutiny by U.S. regulators over whether they may cause cancer. The Food and Drug Administration has asked companies to gather more data on the safety of the therapies.
Diabetes occurs when a person's blood sugar gets too high and the body doesn't produce enough insulin or doesn't use insulin effectively to control the level. An estimated 347 million people worldwide, including about 25.8 million Americans, have the disease according to global health authorities. The condition can lead to heart disease, stroke and blindness.
Dulaglutide is projected to sell $835 million in 2018, according to the average of six analysts' estimates compiled by Bloomberg. Martin said it would be the only weekly injection in the class, and the only one that doesn't require patients to prepare the dose for administration.
In about 900 patients taking dulaglutide, 54 percent of those on the higher dose had hemoglobin A1c scores under 7 percent, a measure of whether the disease is in check. That compared with 31 percent on Merck's Januvia.
In another trial of about 1,000 patients taking dulaglutide or Bristol-Myers's Byetta, along with two other diabetes drugs, 71 percent of patients on dulaglutide had hemoglobin A1c under 7 percent after a year, compared with 59 percent on Byetta.
Mark Schoenebaum, an analyst with ISI Group LLC in New York, was less positive about the results. Dulaglutide looks "undifferentiated from J&J's Invokana and Bristol-Myer's Bydureon," Schoenebaum said in a June 17 note to clients, after the trial results became available online but before they were released for publication by news outlets. "This is in-line or slightly better than investors' expectations."
Patients also lost more weight on dulaglutide than on the other two medications. Those on the highest dose of Lilly's drug lost 2.9 kilograms after two years, compared with 1.8 kilograms for patients on Merck's Januvia. In the other trial, they lost 1 kilogram after one year on the dulaglutide compared with 0.7 kilograms with Bristol-Myers's drug.
"The modest weight loss is important," Martin said. "Other medications that can deliver this glycemic control do that with weight gain."
Lilly also reported side effect data from the trials. Drugs such dulaglutide can cause gastrointestinal upset while patients get adjusted to the medication, though it usually goes away after a few days, Martin said. Less than 3 percent of patients quit taking Lilly's drug because of the side effect, she said.