Eli Lilly ($LLY) and its close diabetes drug development partner Boehringer Ingelheim laid out a slate of positive late-stage data for its SGLT-2 treatment empagliflozin this morning, taking a big step toward a new drug application expected later in the year.
The partners said that the drug hit its primary endpoint in four Phase III studies, with a significant change in HbA1c from baseline compared to placebo for the 10- and 25-mg doses taken once daily.
"Boehringer Ingelheim and Lilly are encouraged by the efficacy and safety results for empagliflozin," said Prof. Klaus Dugi, senior vice president of medicine, Boehringer Ingelheim. "Many patients with type 2 diabetes are not meeting their blood sugar level goals, and alternative treatment options are needed for them. We believe we are now one step closer to bringing a new treatment option to these patients."
The SGLT-2 inhibitors act on a different mechanism than insulin, putting the brakes on glucose in the kidneys and allowing it to exit the body via urine. And a number of companies, including J&J (canagliflozin), have these new drug candidates in the pipeline.
The success of this experimental drug--among its top diabetes programs--is crucial for Eli Lilly, which has been hit with a series of Phase III setbacks in recent months. In particular, its hopes for a new Alzheimer's therapy have at the very least been delayed for three to four years with the Phase III failure of solanezumab. The pharma giant has already lost patent protection on Zyprexa and faces two more big losses later in the year. And CEO John Lechleiter has vowed to rely on internal R&D work to provide new blockbusters to replace its fading market champs.
- here's the press release
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