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Police to probe Novo Nordisk over disclosure delay

Regulator says pharma company was late to announce FDA decision to not approve Tresiba and Ryzodeg
Novo Nordisk headquarters

Novo Nordisk is to face a police investigation in its native Denmark after the company was accused of delaying the disclosure of a regulatory decision for two of its diabetes drugs.

The Danish Financial Supervisory Authority, the regulatory body for the Danish financial system, claims the company was late to post information about the US Food and Drug Administration's (FDA) decision not to approve the insulins Tresiba and Ryzodeg.

According to the Novo, it received a complete response letter with the FDA's decision on February 8, 2013, after the regulator determined more data was needed on the cardiovascular safety of the medicines.

However, Novo did not announce the FDA's decisions until two days later on Sunday February 10, 2013.

According to the Danish Financial Supervisory Authority, Novo should have made an announcement on the Friday evening, considering the impact denial of entry onto the US market for Tresiba and Ryzodeg would have on Novo's economic fortunes.

However, Novo claims its announcement was made in “timely manner” considering it needed to assess the full implications of the FDA decision.

Nevertheless, the company said it acknowledged the decision of the Danish Financial Supervisory Authority and will cooperate with the authorities in the investigation.

If Novo is found to have delayed disclosure it could face a modest fine, although greater problems could arise if the company was to face lawsuits from shareholders.

Novo has already faced an investigation by the Copenhagen stock exchange into the delay in disclosure, although this was closed in May 2013 after it was concluded that Novo did not violate the rules of the stock exchange.

Article by
Thomas Meek

11th December 2013

From: Sales, Regulatory



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