Eli Lilly ($LLY) has added to a body of positive Phase III data for its once-weekly GLP-1 candidate dulaglutide, with two more late-stage studies that have met their main goals. And the data come as the company counts on drugs from its diabetes pipeline to improve its fortunes after suffering from generics competition to fading moneymakers such as Zyprexa.
On Tuesday Lilly marched out results from two Phase III studies of the GLP-1 contender, saying that the pair of trials as well as three other successful late-stage studies would be included in applications for regulatory approval later in 2013. Lilly, a long-time producer of insulin, lacks a marketed GLP-1 drug to rival therapies in the class from diabetes players such as Bristol-Myers Squibb ($BMY)/AstraZeneca ($AZN), which control Byetta and Bydureon, and Novo Nordisk ($NVO), the maker of Victoza. Lilly had partnered with Amylin on Byetta/Bydureon before a messy breakup between the collaborators in 2011.
In top-line results from Lilly's two late-stage studies called Award-2 and Award-4, the company reported that the GLP-1 drug matched insulin glargine in reduction of hemoglobin A1c levels, meeting the main endpoints of the studies. The Award-2 study also showed that its experimental therapy lowered A1c levels better than the insulin glargine in Type II diabetes patients on metformin and glimepiride at one year of treatment. And in the Award-4 study, the therapy in combination with insulin lispro bested A1c drops seen in patients on a combo of insulin glargine and insulin lispro after a half year of treatment.
Lilly didn't report many safety details from the studies, saying little more about side effects other than the most often reported adverse events were "gastrointestinal-related". Obviously, the safety of any drug for a chronic condition like diabetes will be scrutinized closely. Lilly plans to report more details from the studies at future meetings in 2013 and 2014.
"Dulaglutide, if approved, further advances our efforts to offer a broad portfolio of therapies for people with diabetes, many of whom have unique needs," said Enrique Conterno, president of Lilly Diabetes. "The results of our Phase III dulaglutide trials are encouraging and we look forward to sharing more details on the AWARD studies at upcoming scientific meetings."
At Lilly, the game plan has been to have its own GLP-1 drug to complement its growing portfolio of therapies that aim to control diabetes. With 5 positive late-stage studies, the company has a shot at a much-needed approval for dulaglutide.
- here's Lilly's release
- check out Reuters' article
Special Report: Top diabetes drug pipelines of 2012