Lilly bets its diabetes drug dulaglutide can dominate a crowded class

Eli Lilly ($LLY) will hardly be the first in the field of GLP-1 treatments for diabetes if and when it launches dulaglutide, but the company believes its drug has the data to stand out among its rivals and claim the lion's share of a multibillion-dollar market.

Lilly tailored its 9-part Phase III program to pit dulaglutide against its most likely competitors, and the drug is yet to disappoint. Lilly's once-weekly treatment has thus far bested AstraZeneca's ($AZN) Byetta, Merck's ($MRK) Januvia and metformin in controlling blood sugar in Type 2 diabetes.

In its latest results, presented at this weekend's American Diabetes Association conference, dulaglutide proved itself noninferior to Novo Nordisk's ($NVO) blockbuster Victoza--the $2 billion-a-year standard-bearer among GLP-1 therapies. That's the first time a once-weekly GLP-1 agent has ever equaled a daily one in a Phase III trial, Lilly said--including GlaxoSmithKline's ($GSK) recently approved Tanzeum.

The Victoza study isn't intended for regulators, who are already combing through dulaglutide's first 5 late-stage studies, but instead to buoy the drug's potential when it hits the market. Lilly's lengthy developmental schedule has allowed the GLP-1 space to further crowd, but the company believes its slow and steady approach has helped it build a knockout case for dulaglutide as a clear winner in the GLP-1 space, said Sherry Martin, Lilly Diabetes' senior medical director.

"The position that we have worked to develop was to be able to come forth with a data set that we believe would be a differentiator--the number of studies, the active comparator studies, the duration of studies," Martin told FierceBiotech. "We were well aware that this marketplace had a number of other entrants and so specifically wanted to design a very strong clinical program that could provide foundational information on safety and efficacy."

Novo's drug currently holds about two-thirds of the $3 billion GLP-1 market, which analysts say could grow to $5 billion in the coming years. Dulaglutide, with its easy-to-use injector pen and weekly dosing schedule, is Victoza's principle threat, and peak sales estimates have reached as high as $2 billion.

However, when it comes time to compete on the market, the issue of weight loss may work against Lilly and its new drug. In the Victoza-versus-dulaglutide study, patients on Novo's drug lost a statistically significant larger amount of weight than those on Lilly's treatment--about 8 pounds versus 6.4.

Lilly said the reason for the discrepancy remains unknown, as both arms of the study showed similar treatment compliance and gastrointestinal tolerability. Still, the company points out, both charted clinically important weight reduction, and dulaglutide's was enough to clear a secondary endpoint. 

Novo, which is developing a formulation of Victoza specifically for weight loss, took the opportunity to highlight its treatment's performance, saying in a statement that Lilly's results "reinforce the efficacy of Victoza across all clinical trials."

If approved, Lilly's dulaglutide will sell as Trulicity.

- read the statement