Sanofi is accelerating the development of a new Lantus formulation, a move designed to help the drugmaker remain competitive as Novo Nordisk A/S introduces a rival to its best-selling diabetes medicine.
Sanofi, France’s biggest drugmaker, said today it will bypass mid-phase clinical trials for the experimental drug, and begin final-stage testing of the product in the first quarter next year. The Paris-based company decided to move directly to late-stage development after consulting with regulatory agencies, Chief Executive Officer Chris Viehbacher told analysts during a conference call.
“We’ve had regulatory interaction which gives us the confidence that we can go straight through to phase 3,” Viehbacher said during the call. The second-generation version of the treatment has a “different” and “unique” pharmacokinetic and pharmacodynamic profile, meaning that it’s designed to work differently in the body than the older drug, Viehbacher said. Lantus, which Sanofi says is used by about 7 million patients worldwide, is a once-daily shot.
Sanofi is under pressure as Bagsvaerd, Denmark-based Novo Nordisk has filed for the approval of a challenger to Lantus, designed to last longer in the body, and also was faster in bringing to market a medicine from a new class of diabetes drugs that mimics the hormone GLP-1. Pierre Chancel, the head of Sanofi’s diabetes division, said in a September interview the company remained committed to finding a successor to Lantus, whose chemical name is insulin glargine.
Diabetes afflicts 366 million people, killing one every seven seconds, according to figures released Sept. 13 by the International Diabetes Federation. Sanofi said that same month it expected sales of Lantus to reach about 4 billion euros ($5.5 billion) this year.
The French drugmaker has already filed patents on the new Lantus formulation, Viehbacher told analysts today. Sanofi will provide more information on the experimental product in the first half next year, he said, declining to give any additional details.
The profile of Sanofi’s new insulin glargine formulation will be “only significant” if the drug is a longer-acting product that may position it well versus Novo Nordisk’s Degludec and future generic versions of Lantus, Bloomberg Industries analyst Asthika Goonewardene wrote in e-mailed comments.
Degludec, the experimental Novo insulin, 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, Novo said in September. Degludec probably will overtake Sanofi’s Lantus “sometime in the next 10 years,” Novo Chief Science Officer Mads Krogsgaard Thomsen said in a Sept. 15 interview.
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