Novo Nordisk buffs Tresiba's blockbuster rep as Sanofi showdown looms

Novo Nordisk CSO Mads Krogsgaard Thomsen

Back in early 2013, the FDA stunned Novo Nordisk and the analysts covering the big diabetes drug player when regulators overrode their outside advisers and decided to require a cardio safety study of its long-acting insulin Tresiba. And now, as Novo steers its way toward a near-term reappraisal at the FDA, the company is ushering in some new data to support the combination of Tresiba and Victoza as analysts once again say an approval is all but certain.

The combo, marketed as Xultophy, significantly outpaced Sanofi's ($SNY) Lantus in a head-to-head study on patient satisfaction scores, according to Novo Nordisk ($NVO), an aggressive outfit that's been pushing hard to get Tresiba into the giant U.S. market. And while that won't go very far on the regulatory front, the missive is aimed directly at Sanofi's star franchise as the Danish company works to gain a bigger share of the blockbuster diabetes market, which is growing fast globally.

On average, analysts bill Tresiba as a $2.2 billion diabetes franchise. Leading up to the FDA's decision in 2013, just about everyone felt that the FDA would go along with its panel advisers in requiring a cardio safety study after it hit the market. The rejection caught analysts by surprise. And they're just as confident now that the FDA will give its long-sought thumbs-up on Novo's preliminary trial results.

At Jefferies, the odds are 80% in favor of an approval, notes Reuters. And that's on the low end of an 80% to 90% scale favoring a near-term green light. Those odds are based in part on the recent talks a small team at Novo held with the FDA.

"We surmise that the Novo team would not have made the resubmission decision if the FDA raised any major concerns during the discussions," noted Jefferies analysts, according to Reuters.

That decision will have a heavy impact on Sanofi, which has been hustling along its own combination of lixisenatide and Lantus, its franchise drug that brought in $7 billion last year and now faces an onslaught of generic competition. Just yesterday Sanofi said its second pivotal trial of LixiLan scored positive results, clearing the way for regulatory applications on both sides of the Atlantic.

The betting so far on an approval has been so much in Novo's favor that another FDA setback at this stage would leave a nasty dent in the company's share price. But with the FDA approving most everything these days, Novo would seem to be in a secure spot.

"The true impact of a treatment on a patient's life goes beyond efficacy and safety endpoints," said Professor Stephen Gough of the University of Oxford and Oxford University Hospitals NHS Trust about the latest combo data for Xultophy. "The patient's perception of how a treatment influences their well-being and daily living is critical for understanding a therapy's value."

- here's the release (PDF)
- here's the Reuters story