LP-659

iStock, Wasan Tita Under the deal, the Danish pharma will gain access to Longboard’s 5-HT2C receptor superagonist that is currently in late-stage development for seizures in various developmental and epileptic encephalopathies, including Dravet syndrome. Lundbeck is acquiring neurology and rare diseases specialist Longboard Pharmaceuticals for an equity value of $2.6 billion, the companies announced on Monday. Under the terms of the acquisition, Lundbeck will buy all outstanding shares of the California biopharma’s common stock for $60 per share in cash. On a net cash and fully diluted basis, the transaction has an estimated value of $2.5 billon. The boards of directors of both companies have unanimously approved the deal. The acquisition is expected to close in the fourth quarter of this year, given that at least a majority of Longboard’s total outstanding voting shares are tendered, according to Monday’s announcement. The completion of the transaction is also contingent on regulatory clearances and other customary conditions. Lundbeck CEO Charl van Zyl in a statement called the acquisition “transformative,” noting that it will “become a cornerstone in Lundbeck’s neuro-rare franchise, with a potential to drive growth into the next decade.” The centerpiece of the acquisition is Longboard’s lead asset bexicaserin, an orally available and centrally acting superagonist of the 5-HT2C receptor. According to Longboard’s website , bexicaserin is designed to suppress the hyperexcitability that underpins seizures. It has high specificity and selectivity for the 5-HT2C receptor subtype—while having no detected activity against the 5-HT2B and 5-HT2A receptors—which could potentially limit the known safety signals of other 5-HT2-targeting drugs. Truist Securities analyst Joon Lee in a note to investors said that the deal came earlier than expected and undervalues bexicaserin. “We think the outcome is a good one for shareholders, although we feel that some value may have been left on the table,” Lee wrote, noting that “Lundbeck believes bexi can generate $1.5-2BN in peak sales.” Lundbeck expects to launch bexicaserin in the fourth quarter of 2028. The pharma anticipates that the drug will become a “cornerstone” of its neuro-rare disease portfolio. Bexicaserin is being developed for seizures associated with developmental and epileptic encephalopathies (DEE), such as Dravet syndrome and tuberculosis sclerosis complex. Last month, the biotech kicked off the Phase III DEEp SEA study in Dravet syndrome, which will evaluate the safety and efficacy of bexicaserin in approximately 160 patients aged two to 65 years. The candidate previously received the FDA’S Breakthrough Therapy designation for DEE seizures. Lee said that the Longboard acquisition underscores the industry’s growing interest in DEEs and rare epilepsies, in general, and will have “positive derivative read-throughs” for companies such as Jazz, Marinus and Praxis—all of which have drugs approved or in development for DEE. “Bexicaserin addresses a critical unmet need for patients suffering from rare and severe epilepsies, for which there are very few good treatment options available,” van Zyl said. In addition to bexicaserin, the acquisition will give Lundbeck access to an early-stage asset, dubbed LP659, which is being assessed for multiple neurological diseases. The candidate is a centrally acting modulator of the S1P receptor subtypes 1 and 5, which could give it therapeutic potential for Parkinson’s disease, Alzheimer’s disease, multiple sclerosis and lupus.

Neuroscience drug developer Lundbeck is expanding its scope to epilepsy via the $2.6 billion acquisition of Longboard Pharmaceuticals, a company whose lead asset is in late-stage clinical development for a rare, inherited seizure disorder that has few approved treatments. According to deal terms announced Monday, Lundbeck will pay $60 in cash for each Longboard share, representing a 54.2% premium to the biotech’s closing stock price on Friday and a 77% premium to the stock’s average price for the month of September. When La Jolla, California-based Longboard went public in 2021, it priced shares at $16 apiece. Longboard’s lead drug candidate, bexicaserin, is in development for developmental and epileptic encephalopathies (DEEs), a group of disorders that include the rare epilepsies Dravet syndrome and Lennox-Gastaut syndrome. The oral small molecule is an agonist of the 5-HT2C receptor, whose roles include regulating seizure severity. This receptor is already targeted by Fintepla, a UCB drug approved to treat seizures associated with Dravet and Lennox-Gastaut. But Fintepla’s label carries a black box warning for cardiovascular complications. Bexicaserin is designed to selectively target 5-HT2C without also hitting other receptors that can cause adverse effects. presented by Health IT Accelerating Claim Processing: Strategies to Shorten the Life of a Claim These strategies and practices can significantly shorten the life cycle of claims, leading to quicker resolutions and improved financial outcomes. By Greenway Health Jazz Pharmaceuticals’ cannabis-derived Epidiolex, approved for Dravet, Lennox-Gastaut, and tuberous sclerosis complex, has no black box warning. Some high-profile efforts in DEEs have encountered setbacks. In June, Takeda Pharmaceutical reported its drug candidate soticlestat failed separate placebo-controlled Phase 3 tests in Dravet and Lennox-Gastaut. Longboard had been making the case that bexicaserin can stand apart from other approaches to treat epilepsies. In January, the biotech reported Phase 1b/2a data showing a median 53.3% reduction in seizure frequency in patients with DEEs during the 75-day treatment period, results that had the company making claims of best-in-class potential. Shares of the biotech soared more than 300% after that data report. Bexicaserin’s efficacy results are holding up so far. According to a Lundbeck investor presentation, nine-month open-label data show a 57.7% reduction in countable motor seizures. In September, Longboard began a global Phase 3 test enrolling Dravet patients age 2 and older. This clinical trial is part of a broader program planned to evaluate the drug in about 480 patients who have a range of DEEs. The Longboard pipeline also includes LP659, a modulator of the S1P receptor that has potential applications in neuroinflammatory disorders. A Phase 1 single-ascending dose study has been completed but plans for a Phase 1 multiple-ascending dose study are subject to resolution of a partial clinical hold. Both bexicaserin and LP659 were licensed from Arena Pharmaceuticals. presented by Sponsored Post The Promise of Value-Based Care and MedTech Innovation Monica Vajani, Executive Director for mHUB’s MedTech Accelerator, discusses how mHUB is helping innovators transition healthcare towards value-based care. By Monica Vajani - mHUB Lundbeck focuses on neuroscience drugs. The Copenhagen-based company’s top-selling product is Rexulti, a schizophrenia and depression drug that last year expanded its approved uses to include agitation caused by Alzheimer’s disease. The product accounted for 4.5 billion Danish krone (about $661 million) in revenue last year, a 16% increase compared to the prior year, according to the company’s annual report. Within neuroscience, Lundbeck executives have identified rare neurological diseases as an opportunity for pipeline expansion. Lundbeck projects a fourth quarter 2028 launch for bexicaserin. The company estimates the drug could achieve peak sales of $1.5 billion to $2 billion. “This transformative transaction will become a cornerstone in Lundbeck’s neuro-rare franchise, with a potential to drive growth into the next decade,” Lundbeck President and CEO Charl van Zyl said in a prepared statement. “Bexicaserin addresses a critical unmet need for patients suffering from rare and severe epilepsies, for which there are very few good treatment options available.” The boards of directors of both Lundbeck and Longboard have approved the acquisition, which still needs the majority of Longboard’s outstanding voting shares to be tendered. The deal also must pass regulatory muster. The transaction is expected to close by the end of this year. Image: Getty Images, Iaremenko