In big PhIII showdown, Eli Lilly’s dulaglutide bests Byetta and Januvia

CHICAGO--With big hopes for its diabetes business, Eli Lilly ($LLY) has highlighted upbeat data from three late-stage studies of its experimental drug dulaglutide showing that the drug provided better blood-sugar control than Bristol-Myers Squibb's ($BMY) Byetta, Merck's ($MRK) Januvia and metformin. The drug giant aims to seek FDA approval of the once-weekly therapy later this year--making this treatment a critical exhibit in the pharma giant's case that it can turn around the fortunes of its R&D division.

Lilly has delivered some badly needed clinical trials success with dulaglutide after a series of pipeline pratfalls for experimental Alzheimer's disease and rheumatoid arthritis drugs over the past year. The company is banking on new diabetes drugs such as dulaglutide to sustain sales as the old cash cows Zyprexa and Cymbalta fade in the face of generic-drug competition. The dulaglutide data were revealed today at the annual American Diabetes Association meeting.

Dulaglutide could restore some pride in Lilly's much-maligned R&D engine. Lilly scientists invented the so-called GLP-1 receptor agonist, which is designed to stimulate the production of insulin in diabetes to improve control of blood sugar after meals. The drug comes from the same class as Byetta, which Eli Lilly brought to market in 2005 with former partner Amylin before the nasty breakup between the two companies in 2011 and the sale of Amylin last year in a buyout from Bristol-Myers Squibb and AstraZeneca ($AZN).

With dulaglutide, Lilly would follow several marketed GLP-1 drugs, such as Bristol-Myers' and AstraZeneca's Byetta, Novo Nordisk's ($NVO) Victoza and Sanofi's ($SNY) Lyxumia. Bristol-Myers and AZ also market a once-weekly version of Byetta called Bydureon, which would be a rival to Lilly's drug that is also injected once per week.

"Our goal is that we are able to show a very strong clinical package which we think is as strong as any that has been shown to date in this space," said Dr. Sherry Martin, senior medical director for Lilly's diabetes unit, in an interview with FierceBiotech.

In the Award-1 study, Lilly researchers showed that dulaglutide bested placebo and Byetta, which is injected twice a day, in lowering blood sugar. In the Award-5 and Award-3 studies, Lilly's drug showed superior blood-sugar control versus the oral DPP-4 inhibitor Januvia as well as oral metformin. As Martin explained, Lilly aimed to show that its GLP-1 drug would be an effective option to physicians seeking ways to control their patients' diabetes.

Yet the drug faces questions about how differentiated it is versus existing treatments, and there are plenty. In a June 17 note after abstracts on the trials were made available, ISI Group analyst Mark Shoenebaum said dulaglutide seemed "undifferentiated" from Bydureon.

Lilly researchers underscored the weight-loss benefit shown in patients on dulaglutide in all three Phase III studies. Obesity, which was recently classified as a disease, is a leading cause of Type 2 diabetes. Patients on other GLP-1 drugs have lost weight, and Novo aims to market Victoza as a treatment for obesity.

Lilly also set out to establish the safety of its GLP-1 therapy, amid concerns about the effects of such drugs on the pancreas and cancer. There were 9 cases of pancreatitis across the studies and all treatment arms, Martin said, noting that there were no increases in the inflammatory condition associated with dulaglutide. Also, there were no cases of severe hypoglycemia in the trials. The most common side effect was nausea.

As Reuters reported, investigators believe that two cases of cancer in Lilly's Phase III program were unrelated to dulaglutide.

- here's the release
- check out Reuters' coverage
- and Bloomberg's article

Special Report: Top diabetes drug pipelines of 2012