|Novo CEO Lars Rebien Sørensen|
Last year's FDA delay on Novo Nordisk's ($NVO) Tresiba was a major setback for the long-acting insulin that analysts said would severely dampen its earnings potential. But in the ever-changing pharma landscape, a new development has Novo CEO Lars Rebien Sørensen thinking the company may still get Tresiba to the U.S. market ahead of any significant competition.
As Reuters reports, the Danish helmsman delivered his assessment at the company's annual general meeting Thursday. "We judge that we still have an opportunity to launch Tresiba in the United States, if we are successful in the trials, before any significant competitive products are being entered into the market," Sorensen said.
That's big news for Novo, which took a $14 billion market value hit when the FDA last year unexpectedly asked the company to conduct extra heart-risk tests. And it's thanks, in large part, to the recent lawsuit Sanofi ($SNY) slapped on Eli Lilly ($LLY), delaying the arrival of the Indianapolis-based drugmaker's generic of Lantus--the world's top-selling diabetes drug--until at least 2016. A win in court for the French pharma giant could mean a multi-year protection extension on the $7 billion-a-year med, which would also give it more time to switch patients over to a new, long-acting Lantus successor known as U300, for which the the company expects FDA approval in 2015.
"You will have noticed a significant positive development of our share price. It was not necessarily due to the share split but rather due to our competitors," Sorensen said.
As Chairman Goran Ando told Reuters, getting the FDA's green light on Tresiba is one of Novo's most critical short-term goals. The company is looking to build on 2013's U.S. sales of 39 billion Danish crowns ($7.2 billion), which grew 14% over the year prior. But the Danish drugmaker has some work to do in the meantime if it wants to keep U.S. sales expanding in Tresiba's absence.
"I think perhaps the biggest challenge (in 2014) will be to keep up the growth in the U.S., which has been a growth engine for us, without having our new long-acting insulin Tresiba on the market there," Goran told the news service.
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