In the diabetes drug development world, Sanofi's ($SNY) blockbuster basal insulin Lantus offers a tempting competitive target. And yesterday evening Eli Lilly ($LLY) and its partner Boehringer Ingelheim added a few more data points to their case that LY2605541 may be just the program that can topple Lantus from its peak.
In two mid-stage studies LY2605541 not only offered signs of better or equal glycemic control for Type 1 and Type 2 patients. Patients taking the treatment also registered significant weight loss, compared to weight gain on Lantus. The mean weight loss among the group taking Lilly/Boehringer's drug was 2.65 pounds among Type 1 diabetes patients. And the group of patients losing 5 pounds or more--a key measure of weight control--was statistically significantly greater among the experimental drug group than for Lantus.
"As a clinical investigator, these Phase II results are intriguing, as they showed that LY2605541 improved glycemic control in patients with type 1 and type 2 diabetes and produced additional effects, such as weight loss and less variability of blood glucose readings, both within the same day and between days," said Richard Bergenstal, M.D., executive director, International Diabetes Center at Park Nicollet and clinical professor, Department of Medicine, University of Minnesota.
In the super competitive drug business, placebo-controlled studies often aren't enough these days. More drug developers are determined to establish superiority over top-selling treatments in Phase II. And the Lilly/Boehringer team is positioning their product for Phase III results, which are due out next year, and a prospective regulatory filing in 2014.
Diabetes drugs, though, have one of the highest FDA safety standards to clear. So when analysts saw that Lilly's drug had a higher overall rate of hypoglycemia as well as higher levels of triglycerides, Dow Jones noted that at least two analysts were keeping their enthusiasm in check. Credit Suisse analyst Catherine Arnold noted that if the big pharma partners can prove the treatment is safe and continue to edge out Lantus, this experimental therapy would easily be able to break the $1 billion blockbuster sales mark.
The data clearly indicate that this program is one of the most important late-stage drugs in Lilly's pipeline. And they need to notch up a clinical victory.
Sanofi, meanwhile, is touting new data on Lantus which demonstrate that the best-selling insulin does not raise the risk of cancer or cardiovascular disease. One major study of 12,500 people followed over six years helped ease cancer fears, which should help Lantus maintain its preeminent position - for now.