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Novo's long-acting insulin degludec takes big step to megamarket status

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Novo Nordisk ($NVO) scored a thumbs-up from a European Union advisory panel for its long-acting insulin degludec, pushing the pharma company down the road to a key new potential approval that could reshape the fast growing $35 billion market for diabetes drugs. The insulin--now bearing the brand name Tresiba--is aimed squarely at stealing market share from Sanofi's ($SNY) Lantus and is slated for an FDA panel review on Nov. 8.

Analysts' peak sales estimates run from $2 billion to more than $3 billion a year for degludec.

Novo is betting that degludec--which has a longer-acting track record than Lantus--can muscle its way into market that has been growing by leaps and bounds as an epidemic of diabetes sweeps the world, with millions of new patients in China and India. Standard & Poor's analysis concluded recently that the market could hit $58 billion in just 6 years, adding that the trend could put Novo in the ranks of the top 10 pharma companies in the world. And approvals of degludec in Europe and the U.S. would appear to be likely to some analysts.

"Assuming no further delays in the U.S., Novo should have Tresiba approved in the U.S., Europe and Japan during the first quarter of 2013," SEB Enskilda analyst Lars Hevreng notes, according to a report from Bloomberg. With a $5 billion product to protect, Sanofi has made it clear that it will go toe-to-toe with Novo over its claims.

At the big ADA confab earlier this year, Novo Nordisk touted degludec's superior performance to Lantus in reducing instances of night-time hypoglycemia, when blood sugar levels plunge. Novo says that in a head-to-head study--an increasingly popular strategy for late-stage drugs designed to go after a big competitor--its experimental degludec reduced nocturnal hypoglycemia 36% compared with Lantus.

Sanofi in turn blasted back that Novo's study design had skewed the data, giving degludec an unfair advantage. Novo officials indignantly rejected the accusation. And as degludec draws closer to the market, you can expect the squabble to heat up even more.

- here's the press release
- here's the report from Bloomberg
- here's the Reuters story

Special Report: Novo Nordisk--Tresiba - Top diabetes drug pipelines of 2012

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