Lilly’s Drops Peglispro Insulin; Now It Can Focus On Copycat Lantus
This article was originally published in The Pink Sheet Daily
Executive Summary
The company will cease development of the novel long-acting insulin for the treatment of diabetes after previously revealing safety concerns. Lilly will take a $55mn charge in the fourth quarter.
Eli Lilly & Co. will halt development of the novel long-acting basal insulin peglispro (BIL) for the treatment of type 1 and type 2 diabetes, the company announced Dec. 4, roughly nine months after revealing the regulatory filing would be delayed to review a potentially serious safety issue.
The news hardly surprised investors after Lilly announced in February it would delay the regulatory filing indefinitely to further analyze and characterize the effect of the drug on the liver . FDA had said additional clinical study would be required to win approval.
Lilly was positioning peglispro as a rival to Sanofi’s market-leading basal insulin Lantus (insulin glargine), and investors were already cautious about the product’s commercial potential. While peglispro demonstrated superior efficacy to Lantus in Phase III testing, it also increased triglycerides and liver enzymes in some patients, raising questions about how effectively the drug would compete in the market against a well-entrenched rival like Lantus.
After the February announcement, most investors assumed the drug’s future was grim. Lilly said it will take a $55mn charge in the fourth quarter as a result of halting the program.
Lilly noted that despite changes in liver fat observed in patients treated with peglispro versus insulin glargine in the Phase III IMAGINE trials, no drug-induced liver impairment or Hy’s Law cases were observed in the program. The decision to end the program was informed by conversations with regulatory authorities and external experts, Lilly said, not by any new safety issues.
“We know that moving forward would have required a significant amount of time and investment with no assurance that we would find conclusive answers,” Lilly Diabetes President Enrique Conterno said in a statement.
The demise of the program clears up some confusion on the part of investors about how the company would market a novel basal insulin alongside a copycat version of Lantus.
Lilly is one of the frontrunners in the race to bring a rival version of insulin glargine to the market in the US. Lilly and its partner Boehringer Ingelheim GMBH received tentative approval of their insulin glargine formula Basaglar from FDA in August 2014 and just recently cleared the way for a commercial launch in a patent settlement with Sanofi . Under the patent settlement, Lilly/BI can launch Basaglar in the US on Dec. 15, 2016. Lilly will pay Sanofi royalties in exchange.
Lilly already launched the product in Europe as a biosimilar under the name Abasaglar. In the US, Lilly submitted the drug for FDA approval through the 505(b)(2) pathway, which allows drug manufacturers to reference previously approved drugs rather than the new path for biosimilars (Also see "Lilly and Boehringer Ingelheim Launch Biosimilar Lantus In UK, Germany" - Pink Sheet, 9 Sep, 2015.). That regulatory path was taken by Lilly because Lantus is considered a complex drug and was approved through an NDA, not a BLA.