Hanmi throws lifeline to Sanofi diabetes

Sanofi’s answer to its diabetes woes: buy in innovation. A €400m ($434m) licensing deal with Hanmi Pharmaceutical brings in three long-acting agents including a GLP-1 agonist that has shown efficacy with once-monthly dosing.

The French group has thrown down a gauntlet to Novo Nordisk, which has pushed two new GLP-1 projects into phase III, a weekly injection and a daily pill, and has been toying with longer-acting and oral versions of insulin. While Sanofi’s moves show that drugmakers see innovative opportunities in diabetes, no new targets have emerged.

The deal’s timing, a day before Sanofi management is to meet investors in Paris, is a sign of its desire to lift its sagging shares, which have struggled to take off since the first warning of flat growth in the insulin space that ended with former chief executive Chris Viehbacher’s departure last year (Halloween gives Sanofi investors another fright, October 29, 2015). The 1% rise to €93.04 in late afternoon trading may allow successor Olivier Brandicourt to breathe more easily, as it represents at least a modest endorsement of a strategy to place new bets in diabetes.

The same, but more durable

With the collaboration, Sanofi will have worldwide rights to GLP-1 agonist efpeglenatide, LAPS Insulin115 and a combination of the two agents. In many ways it is like holding up a mirror to Novo’s strategy in diabetes, except with the lofty goal of having long treatment duration.

The assets emerged from Hanmi’s Lapscovery technology, which extends the half-life of biological agents by creating Fc fusion peptides and proteins. The most detailed data exist on efpeglenatide, on which Hanmi presented phase II dosing data at the EASD meeting in September.

An 8mg once-monthly dose of the GLP-1 achieved a statistically significant improvement in blood glucose levels when compared to placebo after 16 weeks of treatment. Patients taking the GLP-1 reported a greater incidence of nausea and vomiting, with more than half in a 16mg dosing group reporting nausea and 28.6% vomiting.

If efpeglenatide were to succeed, it would allow Sanofi to leapfrog over Novo and Eli Lilly. Lilly's once-weekly Trulicity has firmly established itself as the new benchmark in the GLP-1 space. Novo’s Victoza, the first daily injection, is forecast to be the biggest seller in 2020 at $3.6bn, but Trulicity will be coming quickly – helped along, in part, by a showing of non-inferiority to Victoza, something an earlier once-weekly GLP-1 had missed (Lilly avoids head-to-head collision with Novo’s market leader, February 25, 2014).

Thus there has seemed to be some urgency from Novo to advance its dual semaglutide projects, the injectable weekly version and the daily oral version code-named OG217SC (Novo gets shot in the arm from semaglutide, September 28, 2015).

Be as good as once-daily

The remaining two projects, LAPS Insulin115 and its combination with efpeglenatide, LAPS Insulin Combo, are earlier stage, with phase I data on the single agent having been presented at the ADA meeting along with preclinical work on the combo.

Weekly insulin would represent an improvement in patient convenience, although it would certainly have to pose no greater risk of hypoglycaemia than Sanofi’s daily insulin Lantus or Novo’s rivals Levemir and Tresiba, the latter of which is about to launch in the US. As for the combination, Novo also has a basal insulin and GLP-1, albeit a daily combination, in the form of Xultophy, but the same non-inferiority test would have to be applied to a once-weekly challenger.

With this deal, Sanofi is making clear that it is not yet ready to give up on diabetes, even if the assets it has acquired represent incremental change. Novo faces its own restless investors on November 19 – they will no doubt be hungry for something just as enterprising.

To contact the writer of this story email Jonathan Gardner in London at jonathang@epvantage.com or follow @ByJonGardneron Twitter

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