Lilly’s once-a-day insulin injection was better than Sanofi’s Lantus in controlling patients’ blood sugar, a measure of how well a patients’ diabetes is under control. Lilly, based in Indianapolis, said it will file for U.S. approval to sell the drug in the first quarter of next year.
The three studies showed increases in rates of liver enzymes, a potential sign of toxicity, and lower rates of good, or HDL, cholesterol, safety issues may give Lilly a hard time when selling the drug, said Mark Schoenebaum, an analyst with ISI Group LLC. U.S. regulators may also require another trial before they will grant approval, he said.
“We are reasonably bearish on this molecule due to potential toxicity concerns,” Schoenebaum wrote in an e-mail. Sales of the drug may be about $600 million by 2020 if it is approved, he said.
Lantus generated $7.59 billion for Paris-based Sanofi last year. The medicine’s sales are projected by analysts to increase to at least $10 billion in 2016, according to estimates compiled by Bloomberg.
Lilly rose less than 1 percent to $59.42 at 4 p.m. New York time. Sanofi rose 1.6 percent to 76.85 euros in Paris.
Lilly has made an aggressive push to expand its diabetes products, with drugs in every class of therapy for what it calls a full suite of offerings for doctors, health insurers and governments.
In three trials including 3,373 patients, Lilly’s insulin was superior to Lantus in controlling blood sugar. It was tested in patients who’d never used an insulin before, those switching over from another insulin, and in combination with a shorter-acting insulin meant to control blood sugar after meals.
Lilly’s drug “is the first basal insulin to demonstrate consistently superior HbA1c reduction versus insulin glargine in Phase III clinical trials,” Enrique Conterno, president of Lilly’s diabetes business, said in a statement announcing the trial results. Lilly will release full results of the trial, which is continuing, later this year.
Basal insulins are designed to be a baseline of blood sugar control. They’re often given with other medications to control elevated blood sugar after meals. The trials tested Lilly’s drug in combination with those drugs and on its own.
In the U.S., 25.8 million people have diabetes, about 8 percent of the population, according to the American Diabetes Association. The adult form of the disease is often driven by obesity, and is projected to grow as American waistlines continue to expand.
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