Novo Nordisk A/S
) accepted a fine worth DKK 500,000 levied by the public prosecutor
in a suit filed by the Danish Financial Supervisory Authority
against the company. In Dec 2013, the Danish Financial Supervisory
Authority had reported against Novo Nordisk, regarding the
company's receipt of a Complete Response Letter (CRL) from the FDA
on Feb 8, 2013.
We remind investors that in Feb 2013 the FDA had declined to
approve Novo Nordisk's Tresiba and Ryzodeg on the basis of the data
submitted by the company. The FDA had then issued a CRL asking Novo
Nordisk to conduct a dedicated cardiovascular outcomes study and
provide additional cardiovascular data.
According to the Danish Financial Supervisory Authority, Novo
Nordisk had violated its obligation under Section 27 (1) of the
Danish Securities Trading Act, which mandated the disclosure of
inside information as soon as possible. The Danish Financial
Supervisory Authority and the public prosecutor claimed that Novo
Nordisk should have issued a company announcement on the evening of
Feb 8, 2013, stating the FDA's decision.
However, Novo Nordisk maintained that the delay in issuing a public
notification of the FDA's decision was due to the conducting of a
detailed analysis of the implications of the decision. With the
company's acceptance of the fine, the case has been settled. Novo
Nordisk stated in its press release that it has accepted the fine
in order to avoid a lengthy lawsuit and preserve company
Meanwhile, Novo Nordisk initiated a cardiovascular outcomes
study (DEVOTE) on Tresiba in Oct 2013. We are encouraged by the
company's progress in the study so far. Patient enrolment in the
study should be completed within the next six months. The company
intends to file an NDA for both Tresiba and Ryzodeg in the first
half of 2015.
Novo Nordisk carries a Zacks Rank #3 (Hold). Some better-ranked
stocks in the health care sector are Allergan Inc. (
), Mallinckrodt plc (
) and AstraZeneca plc (
). While Allergan and Mallinckrodt carry a Zacks Rank #1 (Strong
Buy), AstraZeneca holds a Zacks Rank #2 (Buy).
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NOVO-NORDISK AS (NVO): Free Stock Analysis
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