Novo Nordisk insulin drug rejected

Shares in Novo Nordisk dropped 12 per cent after the Danish drugs company failed to win approval for a crucial new long-lasting insulin.

The US Food and Drug Administration rejected Novo’s Tresiba drug and asked the Danish group to conduct further tests into potential heart risks, a move that could delay the treatment by several years according to analysts.

By lunchtime, the shares were down 12 per cent at 940 Danish krone – having fallen as much as 15 per cent in early trading – wiping about DKr70 billion off Novo’s market value.

Novo has become the Nordic region’s biggest company by market capitalisation by exploiting its position as the world’s largest maker of insulin by sales, and its shares have more than tripled in the past five years.

Tresiba and related product Ryzodeg are touted by the Danish group as being ultra long-lasting, a key benefit for diabetes sufferers who have hitherto had to inject themselves frequently.

But Novo’s leading position in insulin is under attack from France’s Sanofi, which has the best-selling long-lasting insulin on the market, Lantus.

Novo claims that Tresiba lasts longer and can be used in a more flexible routine.

The rejection by the FDA was unexpected. An advisory panel to the regulator approved the drug – also known as Degludec – in November. Regulators in Europe and Japan have approved Tresiba.

The drugmaker said it could not provide the data in 2013 and chief scientific officer Mads Thomsen later said it would not be ready in 2014 either.

Tim Anderson of Bernstein said the best that Novo could now hope for was that Tresiba made it to market in 2015, assuming the new trial enrolls patients quickly and the FDA requires only partial data and not full completion. Waiting for all the data could delay approval to 2017 or 2018, he said. – (Copyright The Financial Times Limited 2013/Reuters)