Shares in Novo, the world’s leading insulin maker and the most valuable company in the Nordic region, slumped 12.5% as it said the decision would make it harder to meet long-term financial targets. Rival insulin producer Sanofi rose 4.5%.
As the world suffers from an epidemic of type 2 diabetes tied to over-eating and lack of exercise, demand for treatments has snowballed. Novo has benefited more than any other company because it is so focused on diabetes, lifting its shares to a lofty premium over other European drug makers.
Novo said the Food and Drug Administration (FDA) had requested additional data from a trial focused on cardiovascular effects before it would consider approving Tresiba and related product Ryzodeg.
The drugmaker, which is banking on Tresiba to keep it in the lead in diabetes care, said late on Sunday it could not provide the data in 2013 and Chief Scientific Officer Mads Thomsen later told Reuters it would not be ready in 2014 either. Waiting for all the data could delay approval to 2017 or 2018, he said, and if the study reveals new risks it may never be approved.
Analysts had been expecting Tresiba and Ryzodeg to sell some $2.8 billion annually by 2017, according to consensus forecasts compiled by Thomson Reuters Pharma. Those numbers look set to fall sharply, since the lucrative US market was seen making up more than half of the total.
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reporter
Park Sae-jin
swatchsjp@ajunews.com