Wednesday, November 09, 2011

Sanofi's Lyxumia: The Crestor to Victoza's Lipitor?

As Sanofi quietly filed its GLP-1 agonist Lyxumia (lixisenatide) in Europe on Nov. 3, there came a chance to consider how this fourth-to-market drug may fare. David Solomon, CEO of Danish biotech Zealand Pharma, which discovered the drug (and stands to make a low double-digit royalty from its sales) applied a statin analogy that partner Sanofi might not appreciate as it gears up to take on Novo Nordisk's incumbent Victoza, which has been flying off the shelves.

"Crestor didn't kill or hurt Lipitor much, but it built a nice $6bn business," Solomon told The IN VIVO blog. "You could argue that Crestor's not as good as Lipitor, but it found it's own spot," he continued. (Responses in writing, please, Sanofi.) In other words, Lyxumia isn't going to displace the mighty Victoza, it will just provide another treatment option for those patients that need a rather longer post-prandial boost (Lyxumia apparently hangs on a bit longer to the GLP-1 receptor than does Victoza). "It's a nuanced effect," he continued, asserting that doctors will choose this profile for some patients depending on indivdual needs.

Naturally enough, one Novo exec we spoke wiht dismisses the new once-daily diabetes contender as a "fourth-in-class, me-worse drug." The exec also dismisses and potential advantage Lyxumia may claim as a result of a label approving the drug's use in combination with basal insulin (a label Victoza tried but failed to get in Europe).

The story doesn't end there, however (though we must point out that Sanofi tucked the EU filing news into its third quarter results). The GLP-1 market overall is growing, and so is the incidence of diabetes worldwide. Meanwhile it's still Sanofi, not Novo, that boasts leading insulin Lantus. And it's on Lantus' mighty back that Lyxumia will ride in order to reach Crestor-like sales (to borrow Solomon's analogy). Indeed, as Solomon puts it, "It [Lyxumia] is not so much going to be a launch, but more of a step-function of Lantus." He estimates that roughly 1 million Lantus patients (of the 7 million total) may take Lyxumia as add-on to control weight issues.

From Zealand's point of view, that would be just fine; after all, "we'll be durably profitable when Sanofi sells just $250 million of Lyxumia," he says, mentioning 2014.

So Lyxumia on its own probably isn't going to make much of a splash, other than perhaps in some emerging markets like Brazil, Argentina and Indonesia, where Lantus is strong and Novo less so. In Europe, the recent approval of Amylin (now ex-Lilly)'s once-weekly Bydureon may provide another headwind.

Yet Lyxumia may prove a useful tool for Sanofi to expand Lantus' reach. And it sets the scene for the far bigger prize, the Lantus-lixisenatide-nice-device combination. Unfortunately this project has already been delayed: Phase III trials aren't now due to start before 2013, putting it behind Novo's effort to combine Victoza with its ultra-long-acting insulin Degludec (recently filed as a standalone and in combination with insulin aspart). But if it gets as far as the regulators, eventually, we bet Sanofi won't tuck it up within its quarterly results, nor accept anything less than Lipitor-like status.

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