Danish pharmaceutical company Lundbeck has announced a definitive agreement to acquire Longboard Pharmaceuticals for $2.6 billion, a move that significantly enhances its pipeline in neuro-rare diseases. The acquisition's centerpiece is bexicaserin, an investigational drug for developmental and epileptic encephalopathies (DEEs), including Dravet syndrome and Lennox-Gastaut syndrome. This strategic move underscores Lundbeck's commitment to addressing unmet needs in severe brain disorders.
Bexicaserin: A Promising Therapy for DEEs
Bexicaserin is an oral, centrally acting 5-hydroxytryptamine 2C (5-HT2C) receptor super-agonist. It is currently in Phase 3 development for the treatment of seizures associated with DEEs. DEEs are a group of severe, early-onset epilepsies characterized by refractory seizures and developmental delays. These conditions often resist treatment, highlighting the urgent need for new therapeutic options.
In a Phase 1b/2a PACIFIC trial, bexicaserin demonstrated a significant reduction in seizure frequency in children with Dravet syndrome and other DEEs compared to placebo. Specifically, the median seizure frequency was reduced by 72.1% in the four Dravet syndrome patients treated with bexicaserin. The treatment was generally well-tolerated, with common side effects including somnolence, decreased appetite, constipation, and diarrhea.
Clinical Development and Regulatory Status
Longboard initiated the global Phase 3 DEEp SEA trial in September 2024 to evaluate bexicaserin's efficacy, safety, and tolerability in approximately 160 participants aged 2 to 65 with Dravet syndrome and other DEEs. Participants will receive either bexicaserin or placebo for about three months, with an option to enroll in a one-year extension study. Bexicaserin has been granted Breakthrough Therapy designation, Orphan Drug designation, and Rare Pediatric Disease designation by the U.S. Food and Drug Administration, which are intended to expedite the development and review of treatments for serious conditions.
Strategic Implications for Lundbeck
Charl van Zyl, President and CEO of Lundbeck, emphasized that this acquisition marks a transformative step in building Lundbeck's neuro-rare franchise. "Bexicaserin addresses a critical unmet need for patients suffering from rare and severe epilepsies, for which there are very few good treatment options available," he stated. Lundbeck estimates bexicaserin's global peak sales potential between $1.5 and $2 billion.
The acquisition aligns with Lundbeck's Focused Innovator strategy, enhancing its capabilities and presence in neuro-rare conditions. The company aims to launch bexicaserin in the fourth quarter of 2028, diversifying its revenue growth and solidifying its position as a leader in neuroscience.
Financial and Closing Details
Under the agreement, Lundbeck will commence a tender offer to acquire all outstanding shares of Longboard for $60 per share in cash. The transaction, valued at approximately $2.6 billion, has been unanimously approved by the boards of directors of both companies and is expected to close in the fourth quarter of 2024, subject to customary closing conditions, including regulatory approvals and the tender of a majority of Longboard's outstanding shares.
