Azetukalner

Jazz Pharmaceuticals will pay milestones as SAN2355 advances, starting with a $7.5 million fee tied to a phase 1 trial.\n Jazz Pharmaceuticals has struck a deal to bolster its epilepsy ambitions, paying Saniona $42.5 million upfront for a preclinical asset designed to address problems faced by GSK’s withdrawn drug Potiga.Dublin-based Jazz is on course to turn its existing epilepsy drug Epidiolex into a blockbuster this year. The Saniona deal gives the company global rights to the next-generation epilepsy drug candidate SAN2355. Saniona began (PDF) GMP manufacturing and toxicology studies for the asset in March, putting it on track to finalize a clinical trial application data package by the end of the year. Jazz will pay milestones as SAN2355 advances, starting with a $7.5 million fee tied to the initiation of the first phase 1 trial. The fee is part of $192.5 million in development and regulatory milestones included in the deal. Jazz is also on the hook for up to $800 million in commercial milestones based on product sales.SAN2355 is a selective small molecule activator of Kv7.2/Kv7.3 potassium channels. GSK’s Potiga showed that potassium channel openers can improve outcomes in patients with partial-onset seizures more than a decade ago, only for regulators to restrict use after reports of discoloration of the skin and retina. The company withdrew the product in 2017, citing (PDF) “very limited uptake” of the drug. Xenon Pharmaceuticals has advanced another potassium channel opener, azetukalner, into phase 3 trials in the belief that the structure of its molecule has fixed the problems that sank Potiga. But Saniona saw a need to go further, specifically by avoiding the Kv7.4/Kv7.5 activation it has identified as the likely driver of urinary retention seen in some recipients of azetukalner and Potiga.SAN2355 selectively activates Kv7.2/Kv7.3 while blocking Kv7.5, a design that Saniona has predicted will reduce urinary retention and adverse effects on the central nervous system. Equally, because SAN2355 is from a different chemical series than Potiga, the biotech sees little risk of skin and retinal discoloration. Convincing Jazz of the merits of SAN2355 gives Saniona its second deal in nine months. The biotech put cash into SAN2355 after licensing essential tremor candidate SAN711 to Acadia Pharmaceuticals for $28 million upfront last year.

The best things come in threes. Over the past two weeks, Jazz Pharmaceuticals welcomed a new CEO , received approval for its brain tumor treatment, and has now inked a deal for the future of its epilepsy pipeline. The Dublin-based drugmaker is partnering with Saniona on its preclinical epilepsy program. It’s paying $42.5 million upfront to the Copenhagen-based biotech for the exclusive global license to a preclinical drug candidate called SAN2355. Saniona could also receive another $192.5 million in development and regulatory biobucks and up to $800 million if certain commercial achievements are reached. Royalties range from mid-single to low-double digits. With its new partner, Jazz hopes to go up against Biohaven and other biotechs working in the Kv7.2/Kv7.3 space. Saniona’s stock price rose 34% on Wednesday morning on the Stockholm stock exchange . Jazz has been known for its sleep disorder and seizure medicines, including Epidiolex, but is now leaning toward a burgeoning oncology portfolio. Epidiolex is expected to reach blockbuster status this year. Saniona’s epilepsy candidate is a subtype-selective activator of Kv7.2/Kv7.3. The potassium channel, found in the brain, plays a role in regulating neuron excitability. The Kv7 space is heating up. Though Biohaven’s BHV-7000 recently failed a Phase 2/3 study in bipolar mania, the experimental medicine is also in mid- and late-stage trials for major depressive disorder as well as focal and generalized epilepsy. Xenon’s azetukalner, also called XEN1101 , is in Phase 3 for epilepsy. Then there’s QurAlis, which plans to begin a proof-of-concept study of its Kv7 asset QRL-101 in rare epilepsy in the first half of 2026, “pending Series C funding,” according to the Cambridge, MA-based biotech’s website. It’s also exploring the potassium channel in pain and ALS . Saniona is much further behind in development. In May, the biotech said it anticipated applying for clinical testing of SAN2355 by the end of this year. A Jazz spokesperson told Endpoints via email that the company “will continue to assess timelines” for IND submission. In a statement, Saniona CEO Thomas Feldthus said Jazz has a “strong track record of rapidly advancing clinical development programs and effectively commercializing novel therapies in neuroscience.” Feldthus said SAN2355 might apply in other neurological conditions as well. “We concluded that we really need a strong partner to take this forward because there’s also competition in this Kv7 space,” Feldthus said Wednesday in an interview. “In order to harvest the full potential — because we think it can be best-in-class — then we need a strong partner now.” Saniona has forged multiple collaborations over the years. The company did an essential tremor deal with Acadia Pharmaceuticals for $28 million upfront last November. It’s also involved in an AbbVie-backed migraine joint venture called Cephagenix, a schizophrenia collaboration with Boehringer Ingelheim, an Alzheimer’s tie-up with AstronauTx, and an obesity pact in Mexico with Medix. Saniona continues to work on other epilepsy and depression programs that it may partner out, according to Feldthus. “We have quite a broad pipeline. We have nearly more programs than people,” he said. Jazz is a repeat dealmaker. It acquired Chimerix earlier this year for $935 million, and the lead drug from that buyout was greenlit by the FDA two weeks ago. Its deals over the years have also included the $7.2 billion purchase of GW Pharma in 2021, which brought it Epidiolex, and a HER2 collaboration with Zymeworks that led to an FDA approval last year.