Novo Nordisk faces police probe
pharmafile | December 11, 2013 | News story | Medical Communications, Sales and Marketing | FDA, Novo Nordisk, police
Novo Nordisk is facing an investigation from Denmark’s police over delaying the release of negative information it received from the FDA on two of its diabetes drugs.
The Danish Financial Supervisory Authority reported the pharma firm to the police for allegedly violating its disclosure obligation under Section 27 (1) of the Danish Securities Trading Act, legislation which imposes a duty to disclose inside information as soon as possible.
Novo received a Complete Response Letter from the US regulator on the evening of 8 February this year, stating that approvals for Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart) “could not be granted on the basis given”.
The US rejection was a major shock for the company since the two drugs sailed through the European authorisation process, and were both given the green light by the European Commission in January.
Analysts have said Tresiba could make more than $3 billion a year.
But the FDA wanted additional cardiovascular data from a dedicated cardiovascular outcomes trial before the review of the drugs could be completed.
The company waited two days to publish the FDA’s decision, making an announcement on 10 February after conducting “an intensive investigation and evaluation of the implications and impact of the agency’s decision”.
It argues that this meant disclosure was carried out in a ‘timely manner’, but the Danish Financial Supervisory Authority disagrees, insisting Novo should have issued a company announcement on the Friday evening.
Novo could face a fine and says it will “co-operate with the relevant authorities in their investigation”.
However, it adds: “Even if the disclosure obligation could be said to apply already on the Friday evening, the company was entitled to delay public disclosure until the implications of the decision had been adequately analysed, which they had been on the Sunday.”
Novo has already been put under the spotlight on this issue: on 12 February this year a similar investigation was launched by NASDAQ OMX Copenhagen to see whether the company was in breach of its obligations as a listed firm.
On 8 May, it announced that “the stock exchange found no basis for concluding that Novo Nordisk had violated the rules, and that it considered the matter closed”.
Novo’s diabetes franchise had sales of $10.9 billion in 2012, up 21% year-on-year, putting the company in a strong position against rivals such as Sanofi.
Tresiba is the first insulin approved in Europe at a higher strength than the EU-wide standard of 100 units/ml, which is significant because patients increasingly require insulin in higher doses to achieve glycaemic control.
Ryzodeg contains the new-generation basal insulin degludec with a bolus boost of insulin aspart in a soluble formulation, which can be administered once or twice-daily with meals.
In studies comparing it to Novo’s own insulin NovoMix, Ryzodeg demonstrated a significantly lower risk of overall and nocturnal hypoglycaemia while achieving the same reductions in HbA1c.
Adam Hill
Related Content
FDA approves AbbVie’s Skyrizi for UC treatment
AbbVie has announced that the US Food and Drug Administration (FDA) has approved Skyrizi (risankizumab-rzaa) …
FDA approves Merck’s Capvaxive for prevention of pneumococcal disease
Merck, known as MSD outside of the US and Canada, has announced that the US …
FDA accepts Eisai’s Leqembi sBLA for early AD treatment
Eisai and Biogen have announced that the US Food and Drug Administration (FDA) has accepted …
