Eli Lilly ($LLY) says its experimental diabetes therapy basal insulin peglispro beat out Sanofi's ($SNY) blockbuster Lantus for reducing levels of HbA1c in a trio of late-stage trials. But at least one prominent analyst swiftly raised questions about potential safety issues for this Lantus rival, which hopes to bite off a big piece of the market as Sanofi settles in for a lengthy legal battle to protect one of its bestselling products.
"These results are promising. Basal insulin peglispro is the first basal insulin to demonstrate consistently superior HbA1c reduction versus insulin glargine in Phase III clinical trials," said
That's a slower turnaround than had been expected in 2013. Early last year Lilly had promised investors that the company was on track for a 2014 filing.
In all three of the trials of the once-daily BLI (LY2605541), investigators reported "a small but statistically significant increase in triglycerides"--a type of blood fat. Also, more patients taking BIL had an increase in the liver enzyme ALT, though there were no reports of severe liver damage.
"Watch liver safety on new $LLY basal insulin," tweeted ISI analyst Mark Schoenebaum Monday morning. "Unclear this will be competitive with $SNY's Lantus or not ... need more info."
In a quick note to investors, Schoenebaum highlighted the liver safety issues and added: "In addition, HDL (good cholesterol) declines and triglycerides (bad) increase. These factors, in my humble (and often incorrect) opinion, will give this drug a difficult commercial profile. In addition, it's conceivable (likely?) that the FDA will want a full blown outcomes trial prior to approval, as it did for Novo's Tresiba."
The FDA, which sets the bar on diabetes drug safety very high, unexpectedly stiff-armed Tresiba last summer after regulators grew concerned about its potential for triggering cardiovascular issues.
Lilly's Lantus competitor is one of a slate of new diabetes drugs that the pharma giant needs to replace franchise therapies now losing out to some brutal generic competition. Eli Lilly was recently stiff-armed on empagliflozin by the FDA over manufacturing issues at Boehringer Ingelheim, its partner. But its big diabetes contender is dulaglutide, a GLP-1 drug now under regulatory review and a potential leader in that market category.
Lilly has been advancing a knockoff of Lantus in the clinic, but was dealt a setback recently as Sanofi filed a lawsuit against the effort, likely triggering a significant delay in getting that drug to the market. Merck, meanwhile, just weeks ago allied with Samsung on a Lantus biosimilar of its own, which could set the stage for considerable competition. Diabetes is a big and very expensive field to tackle. But a group of major companies have been quick to crowd each new category of diabetes drugs, which could crimp revenue in years to come.
- here's the release