Epilepsy is already represented in Jazz Pharmaceuticals’ portfolio by Epidiolex, a drug that treats seizures caused by three rare types of this brain disorder. Epilepsies have many drivers, and Jazz is now expanding its scope with a deal brings it to a different epilepsy target, but in a selective way that could help it stand apart from other companies already in late-stage clinical development.
Dublin-based Jazz has licensed SAN2355, a preclinical small molecule that Saniona developed for epilepsy and other potential indications. According to deal terms announced Wednesday, Jazz is paying Copenhagen-based Saniona $42 million up front for global rights to the asset.
Saniona’s research focuses on drugs that modulate ion channels. These channels move ions in and out of cells, which is important to various physiological processes. One particular ion channel, Kv7, is associated with epilepsy and pain. The challenge facing drug developers is molecules that hit this target can also have off-target effects, leading to adverse events. SAN2355 is a small molecule designed to be a selective activator of Kv7.2 and Kv7.3, two subtypes of Kv7. By selectively activating these channels and avoiding activation of other Kv7 subtypes, Saniona says its drug can suppress seizures without also sparking off-target effects.
Drug researched has already hit Kv7. In 2011, partners GlaxoSmithKline and Valeant Pharmaceuticals received FDA approval for the antiseizure medicine ezobagine (brand name Potiga), a Kv7 channel opener. This drug never became a big seller, and GSK and Valeant withdrew the product from the market in 2017.
More selective Kv7-targeting drugs are in development in the hands of Biohaven Pharmaceuticals and Xenon Pharmaceuticals. Biohaven has advanced its Kv7 activator, opakalim (formerly BHV-7000), to two separate Phase 3 tests in focal epilepsy. Preliminary data from the first study are expected in in the first half of next year. Opakalim is also being evaluated in a pivotal major depressive disorder study. This drug came from Biohaven’s $100 million acquisition of Channel Biosciences in 2022. According to Biohaven, opakalim is designed to target subtypes of Kv7 potassium channels without also engaging other receptors that could spark adverse effects.
Xenon has a broad Phase 3 development program for azetukalner, which it describes as a selective Kv7 potassium channel opener. Two Phase 3 epilepsy studies are evaluating this drug in focal onset seizures; preliminary data are expected in the first half of 2026. Azetukalner is in another Phase 3 test in primary generalized tonic-clonic seizures. A fourth Phase 3 trial is testing the drug in major depressive disorder.
Jazz’s portfolio and pipeline focuses on neuroscience and cancer. The blockbuster narcolepsy drug Xywav is Jazz’s top neuro product and top seller overall, accounting for more than $1.4 billion in revenue last year, according to the company’s annual report. The anticonvulsant Epidiolex, which came from Jazz’s 2021 acquisition of GW Pharmaceuticals, is approaching blockbuster status with $972.4 million in sales last year. This drug, whose main ingredient is derived from Cannabis sativa L., is approved for treating seizures caused by Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex.
Jazz is now responsible for clinical development and regulatory submissions of SAN2355 as well as commercialization of an approved product or products. Saniona is eligible to receive a $7.5 million milestone payment when Jazz starts the first Phase 1 study. Up to $192.5 million more is tied to the achievement of additional development and regulatory milestones; Saniona is eligible for up to $800 million if SAN2355 meets sales targets as well as royalties from Jazz’s sales of commercialized products stemming from the deal.
“This transaction further expands our early-stage neuroscience pipeline building on our existing expertise in the treatment of epilepsy and our R&D team remains committed to developing novel approaches to improving treatment options for people living with epilepsy and other neurologic conditions,” Robert Iannone, Jazz’s executive vice president, global head of research and development, and chief medical officer, said in a prepared statement.
Picture: mrspopman, Getty Images
