Eli Lilly may be having a devilishly hard time developing new CNS drugs, but it's been racking up an impressive set of late-stage data for a roster of new diabetes drugs in the pipeline. Today Lilly says it scored positive data from three Phase III studies of dulaglutide, a once-weekly GLP-1 analog that has the potential to fill the gap left by Amylin's angry termination of a longstanding collaboration on diabetes. Bristol-Myers Squibb ($BMY) bought out Amylin for $5.3 billion earlier this year, with AstraZeneca ($AZN) in-licensing rights to its diabetes portfolio.
Drugs in the GLP-1 class boost insulin secretion, thereby helping patients control critical blood sugar levels. And the three studies will help Lilly ($LLY) make its case that dulaglutide is superiority for HbA1c lowering compared to exenatide (Byetta) twice-daily injection at 26 weeks; metformin at 26 weeks; and sitagliptin (Januvia) at 52 weeks. And Lilly says the data sets the stage for a 2013 regulatory filing--once it has completed its work laying out the cardiovascular risk presented by the therapy.
Lilly has four diabetes drugs in the late-stage pipeline, an important effort to regain the lead in a huge drug market now dominated by Sanofi ($SNY) and Novo Nordisk ($NVO). It's not an easy field. Regulators demand clear safety data on these drugs. But winners can gain a megablockbuster status as this market rises by leaps and bounds around the world.
"We're very encouraged by the results to date from our Phase III dulaglutide trials and are pleased to be one step closer to offering a new GLP-1 treatment option for type 2 diabetes," said Enrique Conterno, president of Lilly Diabetes. "People with diabetes require different treatment options based on their individual needs. That's why Lilly Diabetes is committed to delivering a broad, comprehensive portfolio of therapies."
- here's the press release
Special Report: Top diabetes drug pipelines of 2012