Never a straight line

Never a straight line

A tricky thing about developing new drugs is that a company never knows when they might be blindsided and all of sudden what looked to be a promising new therapy option may not be so promising after all.  This is the situation facing Lilly (NYSE:LYY) who announced this morning that their new basal insulin Peglispro submission to regulatory authorities will be delayed.  The company did not reveal the length of the delay only stating it would be “beyond the first quarter of 2015”.

According to a company issued press release; “Lilly will delay submission in order to generate additional clinical data to further understand and characterize the potential effects, if any, of changes in liver fat observed with BIL treatment in the Phase III trials. Lilly intends that ongoing clinical trials will continue as planned. In the clinical development program to date, in which more than 6,000 patients with type 1 and type 2 diabetes were treated for up to 18 months (approximately 3,900 patients treated with BIL), no drug-induced liver impairment or Hy’s Law cases have been observed.”

Now Diabetic Investor does not see this delay as a major setback for Lilly as the company has already received regulatory approval for their Biosimilar version of Lantus. Nor do we believe this adversely impacts or changes in any way the company’s overall diabetes strategy. The fact is even without Peglispro their diabetes portfolio has everything it needs, Peglispro would be nice to have but not a must have.