Delay is bad news for Lilly’s insulin contender

Lilly says its new long-acting insulin will be delayed by more than a year because of doubts about liver side effects.

The company had planned to file its new basal insulin peglispro (BIL) with the FDA and EMA in the first quarter of 2015, but announced yesterday that it will now carry out further clinical studies to generate more data on the drug.

Its phase III studies have shown changes in liver fat, a potentially serious side effect which could scupper the drug's chances of being approved. Peglispro is a once-a-day alternative to the current biggest-selling long-acting insulin, Sanofi's Lantus, but must prove both efficacy and safety to challenge the tried-and-tested market leader.

Some analysts say the delay could prove fatal for the diabetes treatment, however. Bernstein analyst Tim Anderson said in a note to investors that there was "a high likelihood that the programme is dead from a regulatory standpoint and/or a commercial standpoint".

These views, and Lilly's cautiousness, have undoubtedly been influenced by the FDA decision to reject Novo Nordisk's long-acting Tresiba in 2013 because of concerns about toxicity. Tresiba was approved in late 2014 in Europe in children and adolescents, and Novo is expected to gain US approval by 2017.

Setbacks to competitors is good news for Sanofi, which is expected to gain FDA approval for its next generation Lantus successor, Toujeo, within a few months.

Another factor in the insulin market is the emergence of biosimilar versions of Lantus, with Lilly and Boehringer Ingelheim (BI) collaborating on a product.

The companies gained approval for their product, known as Abasia in Europe in September last year, but it is being blocked in the US by legal action from Sanofi.

Analysts say that if Lilly fails to bring Peglispro to market, it and BI could aim to seize market share from Lantus with an aggressive, low price for its biosimilar, once it is approved in the US.