Novo Nordisk hit hard by U.S. blow to insulin drug

COPENHAGEN (Reuters) - U.S. regulators dealt a major blow to Novo Nordisk's hopes for its new long-acting insulin Tresiba by demanding the Danish drugmaker conduct additional clinical tests to assess potential heart risks.

Shares in Novo, the world's biggest insulin maker, tumbled 15 percent on Monday morning as the company said the decision would make it harder to meet its long-term financial targets, while those in rival Sanofi rose 4 percent.

Novo said the U.S. Food and Drug Administration (FDA) had requested additional data from a trial focused on cardiovascular effects before it would consider approving Tresiba and related product Ryzodeg.

The drugmaker - which is banking on Tresiba to keep it in the lead in diabetes care - said on Sunday it did not expect to be able to provide the data during 2013. Analysts said the FDA's stance would delay Tresiba until 2015 at the earliest.

"It is a really bad situation," said Sydbank analyst Soren Hansen, who expects a delay of two or three years.

Tim Anderson of Bernstein said the best that Novo could now hope for was that Tresiba made it to market in 2015, assuming the new trial enrolls patients quickly and the FDA requires only partial data and not full completion.

Waiting for all the data could delay approval to 2017/18, he said, and if the study reveals new risks it may never be approved.

The setback for Tresiba, also known as degludec, is good news for rival makers of insulin medicines, notably France's Sanofi, whose Lantus product is under threat from Novo's newer ultra-long-lasting treatment.

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.

Optimism about Tresiba and Ryzodeg - which combines degludec with another formulation of insulin - was further boosted by approval in Europe, where both drugs won a final go-ahead last month. They have also been approved in Japan.

Novo Chief Executive Lars Rebien Sorensen said the U.S. move would have no impact on its plans for the roll-out or pricing of the drugs in Europe and Japan.

Tresiba and Ryzodeg have been widely tipped by analysts to become multibillion-dollar-a-year sellers worldwide - but getting there depends on approval in the United States, the world's biggest and most profitable drugs market.

CONFOUNDS EXPECTATIONS

The FDA's decision to issue Novo with a so-called "complete response letter" confounded consensus expectations. Such letters are issued when the U.S. agency determines that an application cannot be approved in its existing form.

"We are surprised and disappointed to receive this letter, but we acknowledge this decision by the FDA and will work with the agency to determine the best path forward to completing the review," Sorensen said.

In fact, concerns about the cardiovascular safety of Tresiba are not a complete surprise, although Novo and most analysts had thought the issue had been resolved.

The FDA advisers' meeting last year expressed concern about a trend toward higher incidence of adverse heart events with the new insulin than with older ones. However, the differences seen in 16 large clinical trials were not statistically significant.

In addition to calling for new trials on Tresiba's heart safety, the FDA said approval for Tresiba and Ryzodeg could not be granted until violations cited in a December 12 warning letter had been resolved.

Novo said the FDA's decision not to grant approval at the present time was not expected to impact significantly its financial forecasts for the current year.

The big concern of investors, though, is that a lengthy delay in getting Tresiba launched in the world's biggest drugs market will seriously undermine Novo's ability to stay ahead of rivals such as Sanofi and Eli Lilly.

Mark Clark of Deutsche Bank said the setback would be seen as "unequivocally good news" for Sanofi's long-acting insulin Lantus, which is the French company's biggest selling product, with sales this year expected to reach some $6.6 billion, 62 percent of which will come from the United States.

The FDA is very cautious about the safety profile of diabetes treatments, following controversy over GlaxoSmithKline's Avandia pill, which was linked to serious heart problems after being on the market for years.

($1 = 0.7474 euros)

(Additional reporting by Ben Hirschler and Ole Mikkelsen; Editing by Dale Hudson and Mark Potter)

Source: http://news.yahoo.com/novo-nordisk-hit-hard-u-blow-insulin-drug-083555652--finance.html

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