In 2018, Eli Lilly will be a very different looking company. Gone will be the mental health franchise that has helped define the Indiana group since the launch of Prozac in the 1980s and which at its peak earned more than $8bn a year, and in its place the bread-and-butter franchise of human insulin and analogues will be the big cash generator.
Thus some excitement has been generated by the news that Lilly’s late entry to the basal insulin space, LY2605541, yielded unexpected weight-loss data in phase II whilst holding its own against Sanofi’s Lantus on other clinical endpoints. If confirmed in phase III trials the Lilly candidate could gain a competitive edge against Novo Nordisk’s degludec, which is awaiting regulatory approval in the US and Europe, and anticipated Lantus biosimilars in a population in which weight-control is important.
Data to be presented at the American Diabetes Association Scientific Sessions in Philadephia June 11 shows that once-daily doses of the Lilly insulin analogue were associated with a statistically significant weight loss of 0.58 kilograms at 12 weeks in type 2 diabetics, compared with slight weight gain for patients taking Lantus.
A competitive hypoglycaemia profile was revealed, with variations – for example, reduced nocturnal hypoglycaemic events for type 2 patients taking the Lilly analogue in a 12 week trial, but also a greater total number of hypoglycaemic events in an eight-week trial covering type 1 diabetics.
Data from a phase III programme initiated late last year will shed further light on its competitive profile, of course, and there is reason to hold off the excitement until that programme is completed in 2014. Analysts from Bernstein noted that the trial could have been designed to show the best characteristics of LY2605541, a charge that Sanofi made against Novo when degludec demonstrated a better hypoglycaemia profile.
Still, it was the most revealing sign so far of how Lilly’s novel basal insulin analogue will stack up against the competition, and served as confirmation that its wide ranging diabetes risk-sharing collaboration with Boehringer Ingelheim could indeed bear fruit at the advanced end of disease progression (Lilly-Boehringer diabetes deal seeks safety in numbers, January 12, 2011).
With a Lantus biosimilar also part of that development agreement, it will certainly give Lilly’s German partner, as well as physicians, patients and payers, some indication that the new long-acting drug offers some enhancement on currently available therapies.
Combined with positive blood pressure safety data last week from GLP-1 agonist dulaglutide, it was also a signal that Lilly may be able to execute an effective defence of its diabetes franchise. ISI Group analyst Mark Schoenebaum notes that Lilly has stopped losing share in the human insulin category with rebates, marketing to academic medical centres where doctors are trained, and co-branding with big retailer Wal-Mart.
Humulog and Humilin R are projected to be the company's first and second biggest sellers in 2018 at $2.51bn and $1.51bn respectively, consensus data from EvaluatePharma reveal. The combined net present value of Lilly or partnered Boerhinger anti-diabetic products either marketed or in phase III development is $20.2bn, about 42% of Lilly’s market value.
Given Lilly’s history of late-stage failures and the high-risk nature of its most immediate pipeline hope, Alzheimer’s disease antibody solanezumab, cultivating the core business is essential. It is far from certain that LY2605541 will compete, but the most recent data is an encouraging signal.