Lilly’s pipeline fires another blank

The writing has been on the wall for Lilly’s basal insulin peglispro for a while, but now it is official: the company has discontinued development of the diabetes drug, a pegylated version of its existing insulin analogue Humalog.

Although the product was not forecast to be a big seller, it is another blow for Lilly’s pipeline after it halted its evacetrapib programme in October. And it will do nothing to assuage calls for the company to strike a deal – especially as its other big hope, the Alzheimer’s candidate solanezumab, remains a high-risk proposition (see table below).

Liver link

What could have been a neat example of lifecycle management has gone awry for Lilly. Although basal insulin peglispro has proven superior to Sanofi’s long-acting insulin Lantus – no mean feat – there was also a worrying increase in liver enzymes (Safety concerns mean Lilly's novel Lantus competitor has much to prove, May 13, 2014). 

This side-effect seems to have done for the drug. Lilly says the decision to discontinue was not caused by any new safety signals, but rather conversations with regulatory authorities about the liver fat data.

And it was not exactly a surprise. EvaluatePharma consensus had once pegged 2020 sales as high as $726m, but this plunged to $116m in August on the heels of full results from the phase III Imagine trials, presented at the American Diabetes Association meeting.

It seems that erstwhile partner Boehringer Ingelheim saw the signs a long time ago – the German company pulled out of development in 2013 (Lilly diabetes risk-sharing starts to unwind as Boehringer pulls back, January 08, 2013). 

At least Lilly can take heart from Jardiance, the Boehringer drug that it co-promotes, the first and so far only diabetes therapy to show a cardiovascular benefit. And in spite of patent expiries, the insulin franchise of Humalog and Humulin is looking surprisingly durable, with the former still set to be Lilly’s top drug in 2020.

Lilly’s top five products in 2020 (based on EvaluatePharma consensus forecasts)
Drug Disease area Class 2014 sales ($m) 2020e sales ($m)
Humalog Diabetes Insulin analogue 2,785 2,900
Alimta Oncology Chemotherapy 2,792 1,974
Cyramza Oncology Anti-VEGF-2 MAb 76 1,655
Humulin R Diabetes Insulin 1,400 1,404
Trulicity Diabetes GLP-1 agonist 10 1,228

Less than fresh

Notably, all of Lilly’s 2020 top-five drugs are already approved, a damning indictment on its pipeline. A previous analysis carried out by EP Vantage found that the company was a poor performer on several measures of innovation, including product freshness, with just 9% of its 2015 sales coming from drugs approved in the last decade (Another fail for Lilly’s labs – time to make a deal? October 13, 2015). 

Things are not set to get much better, especially if solanezumab does not live up to lofty expectations. The beta amyloid-blocking project is a high-risk bet at best – it has already failed once in phase III and data released in July did little to placate the doubters. Lilly is now waiting on results of the Expedition 3 trial, set to read out at the end of 2016.

Other prospects include the Jak inhibitor baricitinib, which if approved will have to fight to carve out a niche in the increasingly competitive rheumatoid arthritis space – on its side is oral dosing and the fact it has beaten Humira in a head-to-head trial (Therapy focus – Baricitinib revives Jak attack on Humira, November 13, 2015). 

Meanwhile, ixekizumab is due an FDA decision in psoriasis early next year, and while lung cancer agent necitumumab – now branded Portrazza – was recently approved in combination with gemcitabine and cisplatin in metastatic squamous NSCLC, it has some stiff competition in the form of the PD-1 inhibitors.

So Lilly’s best hopes rest on sola’s shoulders. If this also falls by the wayside, a pipeline-bolstering deal will be even more necessary.

Lilly’s top-five pipeline prospects (based on consensus forecasts)
Drug Disease area Class Development phase 2020e sales ($m)
Solanezumab Alzheimer’s Anti-beta-amyloid MAb Phase III 1,068
Baricitinib Rheumatoid arthritis JAK-1/2 inhibitor Phase III 867
Ixekizumab Psoriasis Anti-IL-17A MAb Filed 782
Abemaciclib Oncology CDK 4 & 6 inhibitor Phase III 548
Necitumumab Oncology Anti-EGFr MAb Approved November 2015 497

To contact the writer of this story email Madeleine Armstrong in London at [email protected] or follow  @medtech_ma on Twitter

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