Novo makes inroads in Japan with long-acting insulin Tresiba

Novo Nordisk ($NVO) didn't know how fraught its path would be with Tresiba in 2012, when it won Japanese approval for the drug. The company built up Tresiba in the country even as approval in the U.S. was delayed by the FDA. But apparently, all of its hard work in Japan is paying off and may hold some lessons as it works to do the same in the U.S.

The drugmaker's long-acting insulin holds a 33% market share in the country, the best market ratio for Tresiba in the world, Danish newspaper Børsen reports. Novo charted 6% growth for the drug in Japan in 2015.

Even though the med has struggled to gain momentum in Japan, the market there "is continuously becoming aware of Tresiba's benefits," head of Novo's Japan and South Korea division Ole Mølskov Bech told the newspaper. "We are in a phase in which doctors and health personnel have seen such positive experiences using Tresiba that they are becoming more and more secure with the product. It's a positive circle," Bech said.

That model is one that Novo will want to re-examine as it rolls out Tresiba stateside. The Danish pharma won FDA approval for the drug last year after quelling regulators' concerns about potential heart problems linked to the med. In January, it launched Tresiba in the U.S.

Novo is counting on big things for the drug. Analysts see Tresiba bringing in annual sales of $2.4 billion by 2020. Novo sets that number lower, forecasting $1.7 billion in sales for the drug by that year.

Still, the company is doing everything it can to talk up the drug's advantages over its rivals, Sanofi's ($SNY) blockbuster Lantus and follow-up Toujeo. Novo put a strong salesforce behind the med to help it gain market share.

And the company continues to release data showing Tresiba's perks compared to Lantus and Toujeo. In February, Novo pointed to data showing that the drug reduced hypoglycemic events by 30% compared to Lantus. The company has said that Tresiba works better than Lantus and Toujeo in reducing such events.

But some analysts are still questioning whether that data could help Novo overtake its rivals. "Novo could now edge Sanofi in the long-run," Bernstein analyst Ronny Gal said when the data came out. "[H]owever, there is still lots of uncertainty around Sanofi's approach," Gal said, leaving the door open for some stiff competition.

Meanwhile, Novo is also looking to follow-up combo drug Xultophy for growth. The med is "super important" to achieving the company's goal of getting half the U.S. market, R&D chief Mads Krogsgaard Thomsen said last year. But key to its success will be strong sales for Tresiba, he added, which the company wants to market as "the preferred basal insulin," similar to its "preferred GLP-1" Victoza.

- read the Børsen story

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