Mid-stage results showed the drug controlling blood sugar levels at least equal to Lantus. But LY2605541 also helped patients lose weight whereas Lantus and most other insulin products cause a slight weight gain. That’s particularly important for type 2 diabetes patients who often already have weight issues.
Eli Lilly & Co. (NYSE:LLY) split from diabetes partner Boehringer Ingelheim Pharmaceuticals, Inc. earlier this year for LY2605541’s development — meaning Lilly will assume all responsibility for the development and commercialization. The company’s tentatively planning to release phase 3 results next year, which would allow for a marketing application by year’s end.
Diabetes drug dependence
Sanofi’s limping a bit from 2012 patent losses that included blockbuster blood thinner Plavix and blood pressure drug Avapro. Diabetes products remain Sanofi’s best-performing platform, maintaining a 16.7% sales growth last year. A complete loss of Lantus — without an equivalent successor — would prove devastating for the company.
Novo Nordisk is a diabetes leader thanks to the fast-acting insulin NovoLog, which had 2012 sales of 15.693 million DKK (about $2.7 billion at current exchange rates). Then there’s the $1.6 billion GLP-1 agonist Victoza and the $1.8 billion long-acting insulin Levemir. Those figures don’t come close to Lantus’ heights unless added together. Tresiba’s complete response letter was a definite blow so Novo might sit back and hope Sanofi’s candidates also get flagged for more data.
Eli Lilly’s making a broad spectrum of bets on the diabetes market that include a move into Victoza’s GLP-1 territory. But Lilly’s facing a tough year as its $5 billion antidepressant Cymbalta heads for the patent cliff and its pipeline has featured some late-stage cancellations.
Foolish final thoughts
Sanofi needs to bolster Lantus before it’s too late. Novo Nordisk is out of the race in the American market for the near future. Eli Lilly’s pipeline insulin could provide Lantus some competition. But that will require strong late-stage results and making it past the FDA without issue. And a potential cardiovascular safety flagging remains the big, blinking caution sign for all of the diabetes drug candidates.
Brandy Betz has no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. Brandy is a member of The Motley Fool Blog Network — entries represent the personal opinion of the blogger and are not formally edited.
The article The Future of Sanofi’s Insulin Empire originally appeared on Fool.com is written by Brandy Betz.
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