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Lilly, preparing Alzheimer’s drug plans, forms new neuroscience unit in company restructure

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.