ADA cancer-risk data clears Sanofi's Lantus

Remember the Lantus cancer-risk studies from 2009? The ones Sanofi ($SNY) CEO Christopher Viehbacher called "junk science" and promised to prove wrong? Well, new long-term trial data appears to have done just that. In a 12,000-patient randomized trial, no association between Lantus and cancer was found after 6 years of follow-up. And three other studies backed up the no-cancer-link conclusion.

The largest, longest study--dubbed ORIGIN--didn't achieve its goal of showing that Lantus would improve cardiovascular outcomes compared with standard care. But it's the cancer-risk angle that's gaining traction. As Reuters reports, the other three studies compared Lantus with other long-acting insulins. One found a "suggestion" of a link between Lantus and cancer, but only in new insulin users, and when another methodology was used, that suggestion disappeared.

"Independently from what region of the world, what methodology you use, what specific type of cancer you look at, the result is simple--there is no increased cancer risk in patients using [Lantus]," Riccardo Perfetti, VP for medical affairs, told Bloomberg. All the new research was unveiled at the American Diabetes Association's annual meeting in Philadelphia.

Right now, Lantus owns 80% of the long-acting insulin market. With $4.9 billion in 2011 sales, the drug is also the best-selling diabetes treatment in the U.S. And Sanofi needs that Lantus revenue, which accounts for about 12% of its drug sales. It just lost exclusivity on its biggest drug, the clot-buster Plavix.

In fact, Lantus is so dominant that drugs aiming for approval compare themselves to it, including several reported at ADA this week. Clearing the cancer cloud could help the drug retain share as rivals come to market. Novo Nordisk ($NVO), for instance, expects an FDA decision on its new long-acting insulin later this year.

- see the statement from Sanofi
- read the Reuters news
- get more from Bloomberg

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