Eli Lilly & Co.’s experimental drug dulaglutide was as good at controlling Type 2 diabetes as the leading treatment in a clinical trial, providing Lilly with a potential marketing advantage as it seeks to gain approval of the medicine.
Once-a-week dulaglutide was shown to be non-inferior to the highest approved daily dose of Victoza from Novo Nordisk A/S, the best-selling drug in the class, Indianapolis-based Lilly said today in a statement. The study of 599 patients examined the effect on A1c scores, a measure of diabetes control. Lilly’s drug wasn’t shown to be superior to the therapy from Bagsvaerd, Denmark-based Novo, the world’s biggest insulin maker.
Dulaglutide is part of Lilly’s strategy to have a medication in every major class of therapy for diabetics. The company plans to use that portfolio to offer doctors a broad spectrum of treatments as well as to negotiate deals with health insurers and pharmacy managers.
“Options that allow patients to more easily use the treatment are, we believe, important,” Sherry Martin, Lilly’s senior medical director who oversaw the drug’s late-stage clinical trial, said in a telephone interview.
Dulaglutide has been submitted to U.S. regulators for approval, with a decision expected by September. The drug is forecast to sell $853 million in 2019, according to an average of four analysts’ estimates compiled by Bloomberg. It would be the only once-a-week injection that doesn’t also require patients to prepare the dose, as AstraZeneca Plc’s Bydureon does.
Lilly shares rose less than 1 percent to $58.48. Novo shares climbed 5.9 percent to 261.5 Danish kroner, their highest price ever.
The non-inferiority result meets investor expectations, said Timothy Anderson, an analyst with Sanford C. Bernstein & Co. Other data from the full study, such as the drug’s effect on weight, will matter as well. “Dulaglutide should be well-positioned in the marketplace by virtue of attributes like its once-weekly dosing and its small needle size,” Anderson said in a note to clients, comparing it to Victoza’s daily dosing and Bydureon’s bigger needle.
About 25.8 million people in the U.S. have diabetes, or almost 8 percent of the population, according to the American Diabetes Association. The Type 2 form of the illness occurs when the body loses its natural ability to control sugar using insulin produced by the pancreas. It can be caused by obesity.
In Lilly’s study, patients were given either 1.5 weekly milligrams of dulaglutide or 1.8 daily milligrams of Victoza, and their A1c scores were followed over 26 weeks. The company said that side effects were similar for both groups. It will present full data from the study at a medical meeting later this year.
The drugs are part of a class called GLP-1 receptor agonists. They tell the body to make more insulin when needed, as well as reduce the body’s sugar production. Victoza generated $2.07 billion in 2013 sales for Novo Nordisk, according to data compiled by Bloomberg.
“We look forward to reviewing the full data set from this study before assessing its meaning any further,” said Ken Inchausti, a spokesman for Bagsvaerd, Denmark-based Novo.