Company news: Novo Nordisk and Sanofi

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An analyst said Novo Nordisk's experimental long-acting insulin degludec—a would-be competitor to Sanofi's Lantus—could be on the ropes, if FDA briefing documents released ahead of a Nov. 8 advisory panel meeting are any indication. While approved in some ex-US markets, degludec was delayed by FDA so that it could go before the panel. The FDA document confirmed what some analysts have speculated—that the panel will debate a signal of cardiovascular risk seen in pivotal trials with degludec—and will evaluate this risk vs. the purported benefit. Novo has said its agent causes less hypoglycemia than Lantus, a safety claim that could give degludec a competitive edge over Lantus, which enjoys a near monopoly in the basal insulin market. But it's a claim Sanofi has disputed. The French drugmaker has asserted that its Danish competitor “unfairly stacked the deck against them” by structuring the trials to make degludec look better than Lantus,” wrote Bernstein analyst Tim Anderson in an investor note today. “If one believes Sanofi's argument,” according to Anderson, and the hypoglycemia benefit is not “real,” then “this could increase the risk of degludec not gaining US approval, or of getting delayed further.” Anderson's prediction: degludec will clear the FDA panel.

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