Epilepsy is already represented in Jazz Prescribed drugs’ portfolio by Epidiolex, a drug that treats seizures brought on by three uncommon sorts of this mind dysfunction. Epilepsies have many drivers, and Jazz is now increasing its scope with a deal brings it to a special epilepsy goal, however in a selective method that would assist it stand other than different corporations already in late-stage medical improvement.
Dublin-based Jazz has licensed SAN2355, a preclinical small molecule that Saniona developed for epilepsy and different potential indications. In keeping with deal phrases introduced Wednesday, Jazz is paying Copenhagen-based Saniona $42 million up entrance for world rights to the asset.
Saniona’s analysis focuses on medicine that modulate ion channels. These channels transfer ions out and in of cells, which is essential to varied physiological processes. One explicit ion channel, Kv7, is related to epilepsy and ache. The problem going through drug builders is molecules that hit this goal may also have off-target results, resulting in adversarial occasions. 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 different Kv7 subtypes, Saniona says its drug can suppress seizures with out additionally sparking off-target results.
Drug researched has already hit Kv7. In 2011, companions GlaxoSmithKline and Valeant Prescribed drugs obtained FDA approval for the antiseizure medication ezobagine (model identify Potiga), a Kv7 channel opener. This drug by no means turned an enormous vendor, and GSK and Valeant withdrew the product from the market in 2017.
Extra selective Kv7-targeting medicine are in improvement within the fingers of Biohaven Prescribed drugs and Xenon Prescribed drugs. Biohaven has superior its Kv7 activator, opakalim (previously BHV-7000), to 2 separate Section 3 assessments in focal epilepsy. Preliminary knowledge from the primary examine are anticipated in within the first half of subsequent yr. Opakalim can be being evaluated in a pivotal main depressive dysfunction examine. This drug got here from Biohaven’s $100 million acquisition of Channel Biosciences in 2022. In keeping with Biohaven, opakalim is designed to focus on subtypes of Kv7 potassium channels with out additionally partaking different receptors that would spark adversarial results.
Xenon has a broad Section 3 improvement program for azetukalner, which it describes as a selective Kv7 potassium channel opener. Two Section 3 epilepsy research are evaluating this drug in focal onset seizures; preliminary knowledge are anticipated within the first half of 2026. Azetukalner is in one other Section 3 take a look at in major generalized tonic-clonic seizures. A fourth Section 3 trial is testing the drug in main depressive dysfunction.
Jazz’s portfolio and pipeline focuses on neuroscience and most cancers. The blockbuster narcolepsy drug Xywav is Jazz’s prime neuro product and prime vendor total, accounting for greater than $1.4 billion in income final yr, in keeping with the corporate’s annual report. The anticonvulsant Epidiolex, which got here from Jazz’s 2021 acquisition of GW Prescribed drugs, is approaching blockbuster standing with $972.4 million in gross sales final yr. This drug, whose important ingredient is derived from Hashish sativa L., is accepted for treating seizures brought on by Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis advanced.
Jazz is now liable for medical improvement and regulatory submissions of SAN2355 in addition to commercialization of an accepted product or merchandise. Saniona is eligible to obtain a $7.5 million milestone cost when Jazz begins the primary Section 1 examine. As much as $192.5 million extra is tied to the achievement of extra improvement and regulatory milestones; Saniona is eligible for as much as $800 million if SAN2355 meets gross sales targets in addition to royalties from Jazz’s gross sales of commercialized merchandise stemming from the deal.
“This transaction additional expands our early-stage neuroscience pipeline constructing on our present experience within the remedy of epilepsy and our R&D staff stays dedicated to growing novel approaches to bettering remedy choices for folks dwelling with epilepsy and different neurologic circumstances,” Robert Iannone, Jazz’s govt vp, world head of analysis and improvement, and chief medical officer, stated in a ready assertion.
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