The question of if now answered, now it’s just when

The question of if now answered, now it’s just when

This afternoon Lilly (NYSE:LLY) received tentative approval for the insulin glargine product Basaglar™. According to company issued press release; “The U.S. Food and Drug Administration (FDA) today granted tentative approval for Basaglar™ (insulin glargine injection), which is indicated to improve glycemic control in adults with type 2 diabetes and in combination with mealtime insulin in adults and pediatric patients with type 1 diabetes. Basaglar is not recommended for the treatment of diabetic ketoacidosis.  Basaglar is Eli Lilly and Company (NYSE: LLY) and Boehringer Ingelheim’s basal insulin, which is intended to provide long-lasting blood sugar control in between meals and during the night.1

Basaglar has the same amino acid sequence as the currently marketed insulin glargine product and was tentatively approved for use with KwikPen®, a pre-filled dosing device. Basaglar is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin glargine or one of its other ingredients.

With a tentative approval, the FDA has determined that Basaglar meets all of the regulatory requirements for approval, but it is subject to an automatic stay of up to 30 months as a result of litigation filed by Sanofi, claiming patent infringement. Under the Drug Price Competition and Patent Term Restoration Act (“Hatch Waxman”), the FDA cannot give final approval until the end of the 30-month period in mid-2016, unless the court finds in favor of Lilly earlier.”

So now that we know that Lantus will face generic competition, the only remaining questions are when it will get here and when will Sanofi (NYSE:SNY) move into full blown panic mode.  As we have noted on numerous occasions Diabetic Investor is no expert on patent litigation but this is one time we see Sanofi fighting until the bitter end. Take this to the bank, no matter what decisions are rendered that favor Lilly, Sanofi will fight back and fight hard. Sadly this is the only real option Sanofi has as they could never find a suitable replacement for Lantus. They could never execute on their very ambitious and now very dead diabetes strategy. Things have gotten so bad the company pulled the trigger on one of the worst deals in diabetes history.

Honestly we can’t wait for the next earnings call. We can only imagine the creative language the company will use to explain how in the world this approval and the deal with MannKind (NASDAQ:MNKD) are actually good news. It’s been a week since the MannKind deal became public and by all accounts investors aren’t overly thrilled as up until today shares in MannKind were sinking. (Even a dead cat bounces when thrown out of a window.)

Perhaps for the first time the investment community will actually start noticing that when it comes to diabetes Sanofi has screwed things up pretty good. That the company really has nothing of substance in the pipeline and that the MannKind deal will end up costing the company a billion bucks while yielding nothing in return.  We’ve said before but it bears repeating other than Lantus, it’s been a series of failures – Apidra, iBGstar and Lixisenatide.  It’s only a matter of time before we add Afrezza to the list.

The clock is ticking and Sanofi has run out of options, hear that …. That’s the Fat Lady warming up and she’s getting ready to sing the Sanofi diabetes swan song. Se le ve Sanofi ……