Novo confident insulin Tresiba will get U.S. approval-chairman

* Novo chairman says U.S. approval of Tresiba a top priority

* Says stock split not currently on the agenda

* Says company exploring an increase in dividend

By Shida Chayesteh

COPENHAGEN, March 8 (Reuters) - Denmark's Novo Nordisk , the world's biggest insulin producer, is confident U.S. authorities will approve its new long-acting product Tresiba, its incoming chairman said on Friday.

U.S. regulators last month unexpectedly refused to approve Tresiba until the group conducts extra tests for potential heart risks, dealing a blow to one of its key products as well as to its share price.

The drugmaker shed about $14 billion in market value on Feb. 11 after the decision by the U.S. Food and Drug Administration (FDA) was published, although the shares have since recovered much of the fall.

Goran Ando, who will take over as chairman of the board at Novo Nordisk after the annual general meeting on March 20, told Reuters that getting Tresiba approved by the FDA is one the most important short term goals for the group.

"I have all the confidence in the world that we will do that," Ando said in an interview, without going into further details.

"It will take more time than we thought but we will get there," he told Reuters, adding the board was surprised by the FDA's decision last month.

Most investors had expected a green light from the U.S. watchdog, following a positive recommendation from an advisory panel to the FDA last November, despite earlier signals that there might be heart issues with the medicine.

There has been speculation about a potential stock split as Novo's share price has exceeded 1,000 Danish crowns and the outgoing chairman said in January that approval of Tresiba in the Unites States was a condition for a decision to proceed.

Asked about prospects for a stock split, Ando said: "It is nothing that is currently on the agenda."

He added the board would look into increasing dividends.

"I don't think you will see very dramatic changes. But we will look at this," Ando said.

In January, Novo had raised its sales and profit forecasts for 2013 on hopes that Tresiba, also known as degludec, would soon win approval in the United States and add momentum to surging profits.

But following the FDA decision the drugmaker, which is banking on Tresiba to keep it in the lead in diabetes care, has said the earliest it could provide the data requested by the U.S. authorities is in 2015.

As the world suffers from an epidemic of type 2 diabetes tied to over-eating and lack of exercise, demand for treatments has snowballed. Novo has benefited more than any other company because it is so focused on diabetes, lifting its shares to a lofty premium over other European drugmakers.

COMFORTABLE WITH DIABETES FOCUS

That strategy was not set for any major change under the new chairman.

"Is there a reason to change the fundamental things, I don't think so," Ando said.

"I am very comfortable with our focus on diabetes," he said.

The global diabetes market should grow 10 percent annually through 2020, Citigroup estimates, as Western lifestyles are adopted in emerging markets and obesity affects U.S. citizens at ever-younger ages.

Ando said rising competition would present challenges.

"It is a challenge to continue to grow as fast as we have done," he said.

"In the overall diabetes arena, I think it is fair to say that competition is increasing."

Novo Nordisk has overtaken Norway's Statoil as the Nordic region's biggest company by market capitalisation, dominating its home stock market which last month changed the benchmark, from next week, to a new index that caps Novo's weighting at 20 percent .

Shares in Novo Nordisk traded flat at 1,003.00 crowns per share at 1345 GMT, against a 0.5 percent rise in the Copenhagen stock exchange's benchmark index .

(Reporting by Shida Chayesteh,; Writing by Mette Fraende; Editing by Anthony Barker)

((mette.fraende@thomsonreuters.com)(+4533969649)(Reuters

Messaging: mette.fraende.thomsonreuters.com@reuters.net))

Keywords: NOVONORDISK TRESIBA/ CHAIRMAN

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White House ‘Very Confident’ Senate Will Confirm Hagel

An unnamed senior Obama administration official told the National Journal that the White House is “very confident” the Senate will confirm Chuck Hagel to be the next Secretary of Defense.

According to the report, the administration’s whip count currently stands at 57 votes in favor of confirmation, with a few others opposed to the 60-vote threshold. The official said that the total tally in favor of Hagel could be as high as 72 votes.

Hagel’s neocon detractors see the filibuster as the last option in their anti-Hagel arsenal (which began by trying to smear the former GOP senator from Nebraska as an “anti-Semite”). Sen. Roy Blunt (R-MO), who sits on the Armed Services Committee, threw cold water on that idea last week. Senate Minority Mitch McConnell (R-KY) briefly revived the idea on Monday when he wouldn’t rule it out during a local radio interview.

But Sen. John McCain (R-AZ), who appears unlikely to vote in favor of Hagel’s confirmation, said later on Monday that he would not support a filibuster. And with the 55-seat Democratic majority, two Republican senators saying they supported Hagel’s nomination, and two others saying they’d also oppose the filibuster, the New York Times noted that, barring any unforeseen circumstances, “Hagel will almost certainly head the Defense Department.”

“[T]here appears to be enough GOP opposition to an unprecedented filibuster of a Cabinet nominee to, if necessary, generate the 60 votes required for cloture,” Roll Call reported on Tuesday.

Sen. Lindsey Graham (R-SC) suggested that President Obama “reconsider” Hagel’s nomination but when asked about McCain’s new position, the South Carolina Republican seemed unaware. “Did he say that? I didn’t see that. I’m not there yet. But filibustering is something I do very reluctantly,” he said, adding, “Time will tell what we should do.”

If the Republicans decide to filibuster, as MSNBC’s Rachel Maddow noted on Monday, “that means that the Republicans would have to do something historically unprecedented and truly radical if they are going to stop Chuck Hagel`s nomination.”

CNN reports that “there are now at least five Republican senators who would oppose a filibuster of former Sen. Chuck Hagel to be secretary of defense, all but ensuring the embattled nominee will be confirmed in the coming days.”

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UPDATE 2-Shire confident on 2013 as it boosts genetic drugs unit

LONDON, Jan 8 (Reuters) - British drugmaker Shire reassured investors that it was on target to meet 2013 earnings expectations and said it was boosting its genetic drugs line with a new acquisition.

The company, which has expanded by acquiring late-stage or already marketed drugs in niche areas, had a weak third quarter, missing market expectations as it faced increased generic competition for its hyperactivity drug.

However, outgoing CEO Angus Russell will tell investors at a healthcare conference in San Francisco that the company "is now increasingly confident of meeting current consensus earnings expectations for 2013", Shire said in a statement on Tuesday.

Analysts forecast earnings per share of $2.20 in 2013, according to Thomson Reuters I/B/E/S estimates.

The company also reiterated that it would post double-digit earnings growth in 2012.

Earlier on Tuesday Shire said it had agreed to buy Lotus Tissue Repair, a U.S. biotechnology company developing the first treatment for a rare genetic disorder that causes extremely fragile skin and recurrent blister formation.

Shire said the purchase, for an undisclosed sum, would boost the pipeline of its Human Genetic Therapies unit, which makes protein therapies for genetic conditions such as Hunter's Syndrome and Fabry and Gaucher diseases.

Lotus Tissue Repair's lead product candidate, which is in late pre-clinical development, is a protein replacement therapy for the treatment of dystrophic epidermolysis bullosa (DEB), Shire said.

"DEB ... (impacts) the lives of patients and their families, many of whom have few or no treatment options other than palliative care," said Philip J. Vickers, head of R&D at Shire Human Genetic Therapies.

Shares in FTSE 100-listed Shire closed up 2.6 percent at 1,963 pence, their highest level since September.

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