- Eli Lilly on Tuesday announced plans to split into two its division that develops and markets drugs for neurology and inflammatory diseases, a move that appears linked to an anticipated shorter path to market for the company's experimental Alzheimer's treatment donanemab.
- Anne White, a company veteran who is currently president of Lilly Oncology, will head up the neuroscience unit, while the immunology division will be led by Lilly USA president Patrik Jonsson, who will continue in his current role. White won't be directly replaced, as Lilly Oncology will merge with the company's Loxo cancer research unit under the latter division's top executive Jacob Van Naarden.
- The reorganization is a sign of Lilly's diversification and growth beyond its core diabetes business into the fast-moving fields of cancer, immunology and neurology. The pharma has placed some particularly big bets in Alzheimer's disease, with hopes that drug candidates donanemab and zagotenemab could join Biogen's Aduhelm as treatments for the neurological disorder.
After numerous setbacks in Alzheimer's disease, Lilly has high hopes for a breakthrough with donanemab. When the FDA controversially approved Biogen's Aduhelm in June, it set a precedent for other drugs that can effectively remove amyloid lesions in the brain — believed, but not proven, to be the cause of the neurodegeneration that characterizes Alzheimer's.
Donanemab has been shown in testing to similarly clear those amyloid plaques. While the company had expected to need to conduct Phase 3 trials to prove treatment can delay cognitive and functional decline, the FDA decided to grant accelerated approval to Aduhelm on the basis of its ability to remove amyloid from the brain. Following that decision, Lilly changed course and decided to pursue accelerated approval of donanemab. The company expects to file an application with the Food and Drug Administration later this year.
Should the FDA accepts Lilly's application and approve donanemab, Lilly will have a dedicated neuroscience division to back the drug. While the company has a long history in the space, it's only recently began bouncing back from a series of patent expirations with the 2018 approval of the migraine medicine Emgality.
Lilly's immunology division, meanwhile, is growing rapidly due to the psoriasis treatment Taltz. The division could see further boosts, should lebrikizumab and mirikizumab — experimental drugs for eczema and psoriasis, respectively — succeed in the clinic and with regulators. Ronny Gal, an analyst at Bernstein, forecasts Lilly immunology sales could more than double from $2.4 billion in 2020 to $6.1 billion in 2025.
Separating the divisions may therefore allow company leaders to focus on maximizing the sales of new products. "These leadership and organizational changes will allow us to realize the many opportunities we have to improve the lives of people around the world," CEO David Ricks said in a statement.
Combining Lilly's cancer wok into one division reflects the end of a successful experiment that tasked executives of Loxo Oncology, which Lilly acquired for $8 billion in 2019, with revitalizing the pharma's cancer research and development.
Van Naarden took over leadership of the Loxo at Lilly unit earlier this year with the departure of the Loxo's former CEO, Josh Bilenker, to a startup called Treeline Biosciences and will lead the newly merged division.