|Chairmam Goran Ando--Courtesy of Novo Nordisk|
Sanofi ($SNY) had better not get complacent about its place in the diabetes drug market. Novo Nordisk's ($NVO) new chairman still has his sights focused squarely on the the U.S. market where Sanofi's long-acting Lantus now rules supreme.
Goran Ando tells Reuters he is sure Novo's insulin Tresiba, which is already approved in Europe, will win FDA approval in the world's largest market. Yes, it will take longer than expected but Ando said, "I have all the confidence in the world that we will do that."
Tresiba was approved in Europe last year and it was expected the U.S. would also give it a green light. But in a big upset last month, and what Ando says was a big surprise to Novo's board, the FDA said the drug's efficacy data wasn't enough to outweigh worries about cardiovascular risks. With that denial, Sanofi's stock soared and Novo's plunged. Novo lost $14 billion in market share, although it has gotten much of that back, Reuters says.
Novo said it will now take until 2015 to get the FDA the data it is seeking, giving Sanofi some breathing room. Lantus is Sanofi's best-selling drug, bringing in $6.7 billion last year, up 20%. The French drugmaker has been preparing for its first challenge to Lantus' number one spot. Some studies have shown Tresiba outperforming it. Lantus still faces Tresiba in Europe, where Novo can sharpen its marketing in preparation for its hoped-for U.S. launch.
Novo is the largest producer of insulin products in the world, and Ando tells Reuters he has no plans to move away from its focus on diabetes treatments when he takes over. "Is there a reason to change the fundamental things, I don't think so," Ando said. "I am very comfortable with our focus on diabetes."
- read the Reuters story