Round and Round We Go

Round and Round We Go

This morning Lilly (NYSE:LLY) released top line results from three phase three trails for their once-daily insulin peglispro, which according to a company issued press release; “Eli Lilly and Company (NYSE: LLY) today announced positive top-line results of three completed Phase III clinical trials in patients with type 2 diabetes for basal insulin peglispro (BIL), which is being studied as a once-daily treatment for both type 1 and type 2 diabetes. The primary efficacy endpoint of non-inferior reduction in hemoglobin A1c (HbA1c) compared to insulin glargine was met in all three trials. Having met the primary endpoints, superiority for HbA1c lowering was examined and, in all three trials, BIL showed a statistically superior reduction in HbA1c compared with insulin glargine.”

Also noteworthy in the release was the following passage; “In all three clinical trials, more patients taking BIL had an increase in the liver enzyme ALT (alanine aminotransferase) to greater than three times the upper limit of the normal range compared with those taking insulin glargine.  No cases of severe drug-induced liver injury (Hy’s Law) occurred in these studies.  In IMAGINE-2 and IMAGINE-5, liver fat was measured using MRI imaging in a subset of patients.  In the clinical trial of insulin-naive patients with type 2 diabetes (IMAGINE-2), liver fat in patients treated with BIL did not change from baseline while patients taking insulin glargine experienced a decrease in liver fat from baseline.  In the clinical trial of patients with type 2 diabetes who were already taking a basal insulin (IMAGINE-5), patients taking BIL experienced an increase in liver fat from baseline that stabilized after 26 weeks. Liver fat levels did not change in patients taking insulin glargine during the study.”

Even with this possible safety concern Lilly stated they expect to submit the drug to the FDA and European Medicines Agency by the end of Q1 2015.

It’s also noteworthy to remember that Lilly is involved in an intellectual property lawsuit filed by Sanofi (NYSE:SNY) over Lilly’s generic version of Lantus which was submitted to the FDA earlier this year. A regulatory review which is now on hold until there is a resolution to the lawsuit.

What this data indicates to Diabetic Investor is that the clock is ticking and it’s just a matter of time before Lantus, the world’s number selling insulin, faces serious competition. This is one more piece of the puzzle which when complete will reveal a picture of a tougher, even more competitive insulin market. One more step down the road for the insulin market, both short and long acting, becoming a commodity market where price trumps performance.

With each passing day it’s becoming clearer and clearer that for Sanofi the doomsday clock is ticking as they have yet to find anything that will come remotely close to generating Lantus type revenues. Each day the competition, whether it be from a generic Lantus or non-generic which meets and/or exceeds all of Lantus current performance measures, is getting closer to reaching the market. The company will do what they can to delay the inevitable but they cannot the coming tsunami which will topple the Lantus Empire.

The reality is it’s no longer whether will Lantus will face a serious competitor but when this competition will reach the marketplace and how will the company respond. The harsh reality is the legal process will eventually run its course and the non-generic competition will make its way through the regulatory process. Sanofi has nothing in their pipeline and they don’t seem to be in the mood to acquire the pieces that are missing from their diabetes portfolio. Net everything out and it’s just a matter of time before the clock strikes zero and it’s all over for Sanofi.