Novo Nordisk beefs up safety case for Tresiba in market-share fight with Sanofi

NEW ORLEANS--Novo Nordisk’s next-gen basal insulin Tresiba has a tough task: to steal market share from the long-dominant Sanofi product Lantus, and at a time when Sanofi ($SNY) has its own follow-on product Toujeo in the mix. Not to mention a Lantus biosimilar waiting to make its U.S. debut in December.

Novo ($NVO) thinks it has a tag line, though. In late-stage studies, Tresiba patients suffered fewer episodes of hypoglycemia--a feared risk of insulin treatment. And now, the Danish drugmaker has solid proof of that, in a couple of head-to-head trials specifically designed to measure those events.

The SWITCH-1 and SWITCH-2 studies showed that the Novo product significantly lowered rates of hypoglycemia in comparison with the Sanofi drug, while matching it at controlling blood sugar. The advantage for Tresiba was larger in Type 2, where patients taking the drug saw a 30% lower rate of hypoglycemic episodes, including a 42% drop in the rate of nighttime episodes. The reduction in severe hypoglycemia was even larger, with a 51% rate reduction for fully treated patients.

When Tresiba won approval last September, the FDA did not include Tresiba’s benefits on the hypoglycemia side, so Novo wasn’t able to tout that advantage in its launch earlier this year. The SWITCH data might change the agency’s mind on that, opening the door for ads targeting that safety edge. 

And that could be key for Novo's sales in the field. The $9 billion basal insulin market is the most competitive in diabetes, Chief Medical Officer Todd Hobbs told FiercePharma Saturday. And it's about to get more so, with Eli Lilly and Boehringer Ingelheim's Lantus biosimilar, Basaglar, preparing for a December launch.

But Novo has been working to build a case for Tresiba against Lantus already, and Basaglar will essentially be another Lantus, Hobbs said at the American Diabetes Association's Scientific Sessions. Basaglar's differentiating factor will be price, and so Novo will continue to work with payers to press its case for Tresiba's benefits. "That's why we're excited about the SWITCH data," Hobbs said.

In the meantime, Novo is spreading the word among doctors and payers, and analysts see a chance that the hypoglycemia data could help drive Tresiba sales, particularly now, when it's just facing other branded meds. The argument could be tougher after Eli Lilly ($LLY) and Boehringer Ingelheim's Lantus copy hits the market in December, but could be made nevertheless.

The Switch findings were presented at the American Diabetes Association’s annual Scientific Sessions meeting here Saturday. “Hypoglycemia is an ongoing challenge for people with type 1 and type 2 diabetes,” lead Switch 1 investigator Dr. Wendy Lane, a clinical endocrinologist at Mountain Diabetes and Endocrine Center in Asheville, NC, said in a statement. “These findings are important for the diabetes community, and add to the existing body of evidence for Tresiba.”

Bernstein analyst Ronny Gal figures that, if Tresiba can parlay the safety edge over Lantus into bigger sales, Novo will take share from the Sanofi med rather than fending off biosimilars. Bernstein has estimated that the copies will grab 40% of the long-acting insulin market, with Sanofi's Lantus and newer Toujeo keeping about 30%, and Novo's Tresiba and Levemir, an older product, sharing the remaining 30%. But after the Switch data premiered, Gal said, “Novo could now edge Sanofi in the long run.”

Bernstein’s analysts forecast 2020 sales for Tresiba of $1.7 billion. For comparison’s sake, Sanofi’s Lantus sales amounted to about $7 billion last year, and Levemir’s came in at around $2.76 billion.

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Editor's note: This story was updated with comments from Dr. Hobbs.