Novo Sees Degludec Overtaking Lantus ‘in Next 10 Years’

Novo Nordisk A/S’s experimental insulin degludec probably will overtake Sanofi’s Lantus “sometime in the next 10 years,” Novo Chief Science Officer Mads Krogsgaard Thomsen said.

Degludec helped reduce diabetics’ blood-sugar levels as well as Lantus, the world’s top-selling insulin, even when patients didn’t take the drug at set times, according to a study released yesterday at the European Association for the Study of Diabetes conference in Lisbon.

An aging population and lifestyle changes in poorer countries are contributing to a surge in the worldwide number of diabetics, exacerbating the rivalry for market share between Bagsvaerd, Denmark-based Novo Nordisk and Paris-based Sanofi. Novo Nordisk wants degludec to be the first insulin approved for use at any time of day, giving it a chance to leapfrog Lantus, which Sanofi says is used by 7 million patients.

“Degludec will be the biggest insulin,” Thomsen, 50, said in an interview in Lisbon. “It will take years. Which year it is, I can’t tell you at this point, but degludec is a superior product. We’re committed to making it the number one basal insulin in the world.”

Diabetes afflicts 366 million people, killing one every seven seconds, according to figures released Sept. 13 by the International Diabetes Federation.

Regulatory Plan

Novo Nordisk sought a new long-acting insulin because sales of its older product, Levemir, trailed Lantus. The company will file degludec with European and U.S. regulators “in the next very few months,” Thomsen said. The treatment may be approved as early as next year in the U.S., he said.

“We have a very, very compelling case with degludec” and “we will be prepared” if U.S. regulators approve the drug in the second half of 2012, Thomsen said during the interview. Otherwise the approval will likely come in the first six months of 2013, he said.

Diabetes is caused by a lack of insulin needed to convert blood sugar into energy. If not treated, the condition can lead to kidney damage, blindness, heart problems and death. Long- acting insulins such as Lantus seek to replicate the steady stream of the hormone that healthy people produce over 24 hours.

Dosage Timing Range

The study presented yesterday showed that patients taking degludec once a day at varying times fared about as well as those taking Lantus at a fixed hour. In the 26-week trial, patients were asked to alternate the timing of insulin injections to suit their daily activities, creating dosing intervals ranging from eight to 40 hours, according to an abstract of the study.

It shows degludec can be taken “any time of day, on any day, in any patient,” Thomsen said. “You can achieve the same safety and efficacy even with very erratic doses schemes.”

Degludec has been shown to control blood sugar for as long as 42 hours with a single shot, meaning it won’t be a problem if patients forget an injection, Thomsen said. The treatment is an “ultra long-acting” insulin, although Novo decided against seeking a three-times-a-week label for it, he said.

The drug is likely to reap annual sales of 12 billion kroner ($2.2 billion) by 2017, according to Alistair Campbell, a London-based analyst at Berenberg Bank. Philippe Lanone, an analyst at Natixis Securities based in Paris, forecasts degludec will garner 18 billion kroner in revenue a year by 2023.

‘Good Drug’

“Degludec is a very good drug,” Campbell said in a telephone interview last week. “As it stands now, Levemir has a distinct disadvantage compared to Lantus. Degludec has to improve Novo’s market position.”

Sanofi said last week that it expects sales of Lantus to reach about 4 billion euros ($5.48 billion) this year. Pierre Chancel, who heads Sanofi’s diabetes division, said Lantus remains “the gold standard” and will keep growing “well beyond 2015.”

The “differential between degludec and Lantus is going to be minimal,” Campbell said. “I don’t see lots of patients switching off Lantus and going to degludec. What will happen is that in the market share for new-patient starts on insulin, Novo will now be on a much more level playing field.”

Pricing

Degludec is “a pretty smart insulin” and Novo’s target to unseat Lantus “is certainly achievable if they get the pricing right,” David Matthews, professor of diabetes medicine at the University of Oxford, said in an interview.

Patients and health-care professionals would be sure to pick degludec over insulin glargine, the chemical name for Lantus, “if they do equivalent pricing,” enabling the Novo Nordisk product to overtake the Sanofi competitor “easily, within five years,” Matthews said. “But my betting would be they will get it wrong” and make the new drug more expensive.

Novo Nordisk, which hasn’t announced a brand name for degludec, will price the new insulin “anywhere in the range of 10 percent to 30 percent” above Lantus, Thomsen said.

“We will not have a dramatic price premium, even though in the old days this compound could have commanded a very significant price premium,” he said. “We don’t see a situation where this is prudent at this point, because of all the health- care reforms and the macroeconomic environment.”

Target Customers

Degludec will start by initially winning over patients who turn to insulin for the first time, Thomsen said. It will be a treatment option even for diabetics with erratic lifestyles and those who need a lot of insulin and are currently stuck with two Lantus shots a day, he said.

Degludec also will probably be a favorite for family members or health-care professionals who administer the shots to older diabetics and would appreciate more flexible schedules, according to Stephen Atkin, lead investigator of the degludec trial and head of academic endocrinology, diabetes and metabolism at Hull York Medical School in England.

The difference between Lantus and degludec is like that between “a standard Ford and one that’s got a few bells and whistles on it,” Matthews said. “If you want everything to be automatic, you will have to pay a little more. A lot of people won’t do that.”

To contact the reporter responsible for this story: Albertina Torsoli in Paris at atorsoli@bloomberg.net

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net