Dulaglutide, Eli Lilly

The drug: Dulaglutide
The disease: Diabetes
The developer: Eli Lilly
Peak sales potential: Bernstein's Tim Anderson has pegged much of his support for Lilly's late-stage pipeline on dulaglutide, projecting $1.7 billion in sales by 2020. More cautious analysts, though, wonder if $500 million to $900 million a year might be closer to the mark, given the intense competition here.

The scoop: Eli Lilly ($LLY) has spent a fortune assembling some impressive data on this once-weekly GLP-1 drug. It's successfully gone head-to-head with a whole slate of industry leaders like Januvia and Lantus.

Dulaglutide emerged from the American Diabetes Association in June as the clear frontrunner in the Phase III group, especially after GSK's ($GSK) albiglutide was bested by Takeda's Actos in a head-to-head study.

Lilly is banking on an approval, just days ago tapping dulaglutide as one of its top three prospects for a desperately needed 2014 approval.

But it's not that simple. GLP-1 competition is already getting established on the market, including Novo Nordisk's ($NVO) Victoza and Byetta and Bydureon from Bristol-Myers Squibb ($BMY) and AstraZeneca ($AZN). GlaxoSmithKline's contender is also up for an approval now. Sanofi ($SNY) is waiting in the wings after pulling back its application at the FDA for lixisenatide--sold in Europe as Lyxumia--but expects a 2015 approval that would further complicate a crowded field. And a combo Sanofi drug with Lantus is currently being studied in the clinic.

For Lilly to really succeed at a blockbuster level, the pharma giant has to establish a reputation for dulaglutide as the GLP-1 therapy--not one of many. 

A number of unanswered questions about safety data will get a full airing at the FDA, which has a very high safety standard for all new diabetes drugs. Novo Nordisk ($NVO) got a painful lesson in just how vigilant the FDA can be when its long-acting insulin Tresiba was rejected on cardiovascular concerns earlier this year.

Even if it is approved on schedule, the current and prospective competition could make this drug something less than a blockbuster. And after all the disappointments that Lilly has experienced over the years, critics have good cause to wonder if this drug can live up to the high expectations.

For more:
In big PhIII showdown, Eli Lilly's dulaglutide bests Byetta and Januvia
Lilly scores a slate of PhIII wins in push for once-weekly diabetes drug

Dulaglutide, Eli Lilly
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