By Shida Chayesteh
COPENHAGEN (Reuters) - Novo Nordisk, the world's largest insulin maker, is facing a Danish police probe after it was reported by the financial watchdog for not disclosing at once that its big new product hope Tresiba had been refused U.S. approval.
Although the probe is unlikely to have a serious financial impact on the company, the largest by market value in the Nordic region, it may tarnish its reputation and could leave it open to lawsuits from investors in the United States, where its shares also trade.
The Danish Financial Supervisory Authority (FSA) said on Tuesday Novo should have issued a statement about the U.S. decision not to approve Tresiba, its new long-acting insulin, on the evening of Friday, February 8 instead of waiting until Sunday, February 10.
The news that the Food and Drug Administration (FDA) had rejected Tresiba, a treatment for diabetes, and a related combination drug called Ryzodeg was a major blow to Novo and confounded the expectations of investors, who had expected a green light.
Shares in Novo fell as much as 17 percent at one stage on February 11, their biggest daily decline since 2002.
Novo said on Tuesday its announcement about Tresiba was issued "in a timely manner". However the company said it would cooperate with the investigation, which could result in a modest fine.
Hanne Rae Larsen, head of the FSA's stock exchange division, said fines for disclosure violations were typically in the range of 50,000 to 200,000 Danish crowns ($9,000-37,000), a fraction of the 21.4 billion crowns net profit Novo made last year.
"When the case goes over to the police, they will usually try to close it with a fine. If Novo Nordisk accepts any sanction, the case will close. If Novo does not recognize that there has been a violation, there will be a lawsuit," she told Reuters.
Sydbank analyst Soren Lontoft Hansen said: "It will cost them more in terms of image than it will financially. What might be a bigger problem financially is if U.S. shareholders get together in a joint action."
A police spokesman said it was still awaiting details of the case to be passed on from the FSA.
The drugmaker argues that even if the disclosure obligation applied from Friday evening - the time it received the bad news from the FDA - it was entitled to delay an announcement until it had analyzed the implications.
But the situation is complicated by the fact that although the FDA news came after the Danish market was closed, it was still possible to trade Novo shares over the counter and through banking systems. Furthermore, trading in Novo's American depository receipts was still active.
A Novo spokesman said the company's U.S. unit received notification from the FDA at around 5 p.m. Danish time on February 8, just as the Copenhagen market was closing, but it only sent the message on to headquarters "some hours" later.
There was an internal conference call about the matter between 9 p.m. and 10 p.m. that night and Novo finally published the information on Sunday, February 10, at 9.09 p.m., according to the FSA.
Novo has benefited more than any other company from a global epidemic of type 2 diabetes, which in recent years has fuelled demand for its products and lifted its shares to a lofty premium over other European drugmakers.
Tresiba was widely seen as another sure-fire winner, especially as the drug had already won approval in Europe and Japan, and also got a positive recommendation from an advisory panel to the U.S. FDA in November 2012.
In the event, the FDA requested additional data from a new clinical trial focused on cardiovascular side-effects before it would consider approving Tresiba.
The U.S. setback, which will delay Tresiba's launch in the world's biggest market by several years, is good news for rival makers of insulin medicines, notably France's Sanofi, whose Lantus product is threatened by Novo's newer ultra-long-lasting treatment.
Novo noted that the Copenhagen stock market had launched a similar investigation in February into whether it had violated specific stock exchange disclosure rules, but had concluded in May that there was no case to answer.
The FSA, however, said the fact the local market was closed had no bearing on Novo's disclosure obligations under the Security Trading Act.
Shares in Novo were 0.6 percent lower by 1026 GMT, slightly underperforming a 0.3 decline in the European pharmaceuticals sector. ($1 = 5.4375 Danish crowns)
(Additional reporting by Teis Jensen and Ben Hirschler; Editing by Erica Billingham)