Eli Lilly ($LLY) took another big step toward filing its long-acting insulin peglispro for an approval, racking up some more positive HbA1c Phase III data in a head-to-head showdown with Sanofi's ($SNY) bestselling Lantus. The pharma giant won't roll out the actual numbers until next year, but investigators say their basal insulin peglispro demonstrated "consistent superiority" over Lantus on the hemoglobin A1c score, with more Type 1 patients beating the key 7% mark for consistent glycemic control.
In the studies, peglispro was also credited with a better record on weight reduction, a key secondary goal in these studies. But Lilly also was forced to concede that in one of the two Phase III trials there was a statistically significant increase in daytime hypoglycemic events, an important safety measure, compared to Lantus. Even with an approval, any safety issues could carve out market value from a new diabetes treatment in this hotly competitive space.
The results from the two Phase III studies IMAGINE-1 and IMAGINE-3 in type I diabetes completes the trials planned for peglispro, and leaves Eli Lilly on track to file for an approval in the first quarter of next year.
The latest Phase III results add to the positive data that Lilly reported from a separate Phase III trial last spring. But at least one analyst also raised the prospect of a kickback from regulators, who might demand a followup safety study after seeing signs of liver toxicity.
Beating Lantus has been a big focus in diabetes drug development, a game of one upmanship as the world's dominant players in the field jockey for a better position in the fast-growing megablockbuster drug market. Eli Lilly, though, which has had to cut back and freeze salaries as revenue plummets in the wake of a long clinical drought, has more riding on this than some of its rivals. Expanding on a multibillion-dollar diabetes franchise is at the heart of Lilly's comeback plan, and any fresh setbacks would do serious damage to the case it has been making with the investment community.
These me-better drugs face an uncertain future on the market. Deutsche Bank analyst Gregg Gilbert just pegged sales of peglispro at $600 million in 2020, and Lilly needs blockbusters to compensate for the revenue its losing now to generic competition.
Lilly developed a knockoff of Lantus, which earned close to $8 billion last year, only to see it get tied up in U.S. courts. Lantus loses patent protection next February. Lilly's best near-term shot at glory, though, remains dulaglutide, its GLP-1 contender that proved non-inferior to Novo's once-daily Victoza.
Sanofi hasn't been idle, though. It's completed Phase III trials for its own next-gen version of Lantus, the long-acting Toujeo (U300), which is now under FDA review and likely to beat Lilly to the market. Novo Nordisk is fighting back on the long-acting front, meanwhile, recently saying that it would be back at the FDA with its long-acting rival Tresiba in 2015, ahead of schedule with a program that was forced back into the clinic to do a cardio safety study by fretful regulators.
"These data are promising and give us further confidence in the clinical profile of BIL (peglispro)," said Enrique Conterno, president of Lilly Diabetes. "Lilly is committed to meeting the diverse needs of people living with diabetes who need therapies that will help them meet their individual goals. If approved, we believe BIL will be an important new basal insulin option for people with diabetes."
- here's the release