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.
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