|Novo Nordisk CEO Lars Rebien Sørensen|
Last year's stinging FDA rejection for Novo Nordisk's ($NVO) Tresiba wiped billions off the drugmaker's market cap, but, despite getting bogged down with new safety studies, the company believes it can still get its long-acting insulin on the market before its rivals can settle in.
Speaking to Reuters at Novo's annual meeting, CEO Lars Rebien Sørensen said the company believes it can wrap up its FDA-mandated cardiovascular study and convince regulators of Tresiba's safety profile, launching the drug and salvaging some potential of treatment once expected to peak at $3.4 billion a year.
The company is now in a race with its competitors to market Tresiba before the crowded diabetes space gets further diluted by a new crop of hopefuls, and, thanks to rival Sanofi ($SNY), Novo may just succeed. In an effort to protect its top-selling Lantus, Sanofi filed suit to stall Eli Lilly's ($LLY) introduction of a biosimilar, extending the French outfit's market exclusivity but inadvertently stretching Novo's window of introducing its own long-acting insulin before generic competition enters the stage, Reuters notes.
First, of course, it has to finally win FDA approval for Tresiba, which Chairman Göran Ando told the news service is one of Novo's biggest short-term goals. The drug is already on the market in Europe, but Novo needs to keep the pace in the U.S. if it wants to sustain 2013's sales growth, Ando said.
But the world's largest insulin outfit is hardly hitching its entire future to a me-too therapy. The company is staking about $3.7 billion on diabetes R&D to follow up on its blockbuster Victoza, working through Phase III for the weekly GLP-1 injection semaglutide and the daily liraglutide, Phase II development of the oral NN9924, and a host of early-stage therapies.
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