Lundbeck planning for four novel drugs in phase 3 in 2026

Denmark's Lundbeck has said that efforts to build its R&D portfolio are on track to deliver four new molecular entities (NMEs) in phase 3 trials in 2026, including an epilepsy drug from its recently announced $2.6 billion takeover of Longboard Pharma.

In a business update delivered to analysts and investors, the central nervous system disease specialist said that the development of its pipeline will be supported by growth in two key brands – Rexulti (brexpiprazole) for agitation in Alzheimer's patients and Vyepti migraine therapy (eptinezumab) - which will drive "mid-single-digit revenue growth " through 2027.

The two drugs will account for nearly two-thirds of Lundbeck's revenues in that year, predicted the company's president and CEO Charl van Zyl, while the late-stage pipeline will "prime us for sustainable long-term growth into the future, and solidify our position as a leader in neuroscience that can deliver impactful treatments benefitting patients, people, and society."

The four phase 3 hopefuls are headed by anti-alpha-synuclein antibody amlenetug, which is scheduled to start a phase 3 programme in multiple system atrophy (MSA) in early 2025.

Following after are an anti-PACAP drug Lu AG09222, which is in phase 2b testing for migraine prevention, and adrenocorticotropic hormone (ACTH) blocker Lu AG13909 for Cushing's disease and congenital adrenal hyperplasia (CAH) in phase 1b/2 trials.

Longboard's 5-HT 2C receptor super-agonist bexicaserin for seizures associated with rare forms of epilepsy, which is due to start phase 3 within the next few months, will round out the quartet – assuming of course the takeover completes as expected.

Lundbeck has said it thinks the drug could achieve peak sales of $1.5 billion to $2 billion if approved for multiple developmental and epileptic encephalopathies (DEEs), a group of disorders that includes Dravet syndrome and Lennox-Gastaut syndrome.

The drugmaker needs its pipeline to deliver as it prepares for the loss of market exclusivity for antidepressant Trintellix/Brintellix (vortioxetine) – for many years its biggest-selling drug – in 2026. It is targeting two to three new product launches before 2030.

It also revealed during the uptake that it will write down part of the book value of its $400 million acquisition of Abide Therapeutics in 2018 after the failure of an early-stage candidate, but said there is "still significant potential value remaining from this acquisition," which included a range of inhibitors of serine hydrolases.

The lead candidate in that deal – an MAGL inhibitor for Tourette's syndrome – was dropped in 2020 after disappointing phase 2a results.