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Jazz Pharmaceuticals Enters Exclusive Licensing Agreement with Saniona to Develop and Commercialize SAN2355

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Jazz Pharmaceuticals (Nasdaq: JAZZ) has entered into a global licensing agreement with Saniona (Nasdaq OMX: SANION) for exclusive worldwide rights to develop and commercialize SAN2355, a preclinical asset for epilepsy treatment. Jazz will pay $42.5 million upfront to Saniona.

The agreement includes potential payments of up to $192.5 million in development and regulatory milestones, including $7.5 million for Phase 1 initiation, up to $800 million in commercial milestones, and tiered royalties from mid-single digits to low-double digits on net sales.

SAN2355 is a subtype-selective Kv7.2/Kv7.3 activator designed to overcome limitations of non-selective Kv7-targeting compounds. Jazz will lead and fund development, regulatory submissions, and global commercialization efforts.

Jazz Pharmaceuticals (Nasdaq: JAZZ) ha stipulato un accordo di licenza globale con Saniona (Nasdaq OMX: SANION) per i diritti esclusivi mondiali di sviluppo e commercializzazione di SAN2355, un candidato preclinico per il trattamento dell'epilessia. Jazz verserà a Saniona un pagamento iniziale di 42,5 milioni di dollari.

L'accordo prevede pagamenti aggiuntivi legati a risultati di sviluppo e regolatori fino a 192,5 milioni di dollari, inclusi 7,5 milioni di dollari per l'avvio della Fase 1, e fino a 800 milioni di dollari in milestone commerciali, oltre a royalty a scaglioni che vanno da una percentuale media bassa fino a una percentuale bassa a due cifre sul fatturato netto.

SAN2355 è un attivatore selettivo per i sottotipi Kv7.2/Kv7.3 progettato per superare i limiti dei composti non selettivi che mirano a Kv7. Jazz guiderà e finanzierà lo sviluppo, le sottomissioni regolatorie e la commercializzazione globale.

Jazz Pharmaceuticals (Nasdaq: JAZZ) ha suscrito un acuerdo de licencia global con Saniona (Nasdaq OMX: SANION) para obtener los derechos exclusivos mundiales de desarrollar y comercializar SAN2355, un activo preclínico para el tratamiento de la epilepsia. Jazz pagará a Saniona un anticipo de 42,5 millones de dólares.

El acuerdo contempla pagos adicionales por hitos de desarrollo y regulatorios por hasta 192,5 millones de dólares, incluido un pago de 7,5 millones por el inicio de la Fase 1, hasta 800 millones de dólares en hitos comerciales, y regalías escalonadas que van desde cifras medias bajas hasta cifras bajas de dos dígitos sobre las ventas netas.

SAN2355 es un activador selectivo de los subtipos Kv7.2/Kv7.3 diseñado para superar las limitaciones de los compuestos no selectivos que actúan sobre Kv7. Jazz liderará y financiará el desarrollo, las presentaciones regulatorias y la comercialización global.

Jazz Pharmaceuticals (Nasdaq: JAZZ)µç� Saniona (Nasdaq OMX: SANION)ê³� ì � 세계 ë…ì ì � 권리ë¥� 부여하µç� 글로벌 ë¼ì´ì„ ìФ 계약ì� 체결하여 간질 치료ìš� ì „ìž„ìƒ� 후보물질 SAN2355ì� 개발 ë°� ìƒì—…í™� 권한ì� 확보했습니다. Jazzµç� Sanionaì—� 초기ê¸� 4,250ë§� 달러ë¥� 지급합니다.

ë³� ê³„ì•½ì—µç” ìž„ìƒ ë°� 규제 마ì¼ìŠ¤í†¤ìœ¼ë¡œ 최대 1ì–� 9,250ë§� 달러ì� 추가 ì§€ê¸� 가능성ì� í¬í•¨ë˜ë©°, ì—¬ê¸°ì—µç” 1ìƒ� 개시ë¥� 위한 750ë§� 달러가 í¬í•¨ë©ë‹ˆë‹�. ë˜í•œ ìƒì—…ì � 마ì¼ìŠ¤í†¤ìœ¼ë¡œ 최대 8ì–� 달러와 ìˆœë§¤ì¶œì— ëŒ€í•� 중저(중간 단ì¼ìžë¦¬)ì—서 ë‚®ì€ ë‘� ìžë¦¿ìˆ˜ê¹Œì§€ì� 계단ì‹� 로열í‹�ê°€ ì ìš©ë©ë‹ˆë‹�.

SAN2355µç� 비선íƒì  Kv7 í‘œì  í™”í•©ë¬¼ì˜ í•œê³„ë¥� 극복하ë„ë¡� 설계ë� Kv7.2/Kv7.3 소아í˜� ì„ íƒì � 활성제입니다. Jazzê°€ 개발, 규제 제출 ë°� ì � 세계 ìƒì—…í™� 작업ì� 주ë„하고 ìžê¸ˆì� ì§€ì›í•©ë‹ˆë‹¤.

Jazz Pharmaceuticals (Nasdaq: JAZZ) a conclu un accord de licence mondial avec Saniona (Nasdaq OMX: SANION) pour obtenir les droits exclusifs mondiaux de développer et commercialiser SAN2355, un candidat préclinique pour le traitement de l'épilepsie. Jazz versera à Saniona un paiement initial de 42,5 millions de dollars.

L'accord prévoit des paiements éventuels liés à des jalons de développement et réglementaires pouvant atteindre 192,5 millions de dollars, y compris 7,5 millions de dollars au démarrage de la phase 1, jusqu'à 800 millions de dollars en jalons commerciaux, ainsi que des redevances échelonnées allant d'un faible chiffre médian à un bas chiffre à deux chiffres sur les ventes nettes.

SAN2355 est un activateur sélectif des sous-types Kv7.2/Kv7.3 conçu pour pallier les limites des composés non sélectifs ciblant Kv7. Jazz prendra en charge et financera le développement, les soumissions réglementaires et la commercialisation mondiale.

Jazz Pharmaceuticals (Nasdaq: JAZZ) hat eine globale Lizenzvereinbarung mit Saniona (Nasdaq OMX: SANION) geschlossen, die Jazz exklusive weltweite Rechte zur Entwicklung und Vermarktung von SAN2355, einem präklinischen Wirkstoffkandidaten zur Behandlung von Epilepsie, einräumt. Jazz zahlt an Saniona eine Vorauszahlung in Höhe von 42,5 Millionen US-Dollar.

Die Vereinbarung sieht weitere leistungsabhängige Zahlungen bis zu 192,5 Millionen US-Dollar für Entwicklungs- und Zulassungserfolge vor, darunter 7,5 Millionen US-Dollar bei Beginn von Phase 1, bis zu 800 Millionen US-Dollar an kommerziellen Meilensteinen sowie gestaffelte Lizenzgebühren von mittleren einstelligen bis zu niedrigen zweistelligen Prozentsätzen auf den Nettoumsatz.

SAN2355 ist ein subtypselektiver Kv7.2/Kv7.3-Aktivator, der entwickelt wurde, um die Einschränkungen nichtselektiver Kv7-wirkender Verbindungen zu überwinden. Jazz wird die Entwicklung, regulatorische Einreichungen und die weltweite Kommerzialisierung führen und finanzieren.

Positive
  • Upfront payment of $42.5 million strengthens Saniona's financial position
  • Potential for substantial milestone payments totaling up to $992.5 million
  • Partnership with Jazz leverages their expertise in epilepsy drug development and commercialization
  • SAN2355's selective mechanism potentially offers best-in-class treatment approach
Negative
  • SAN2355 is still in preclinical stage, indicating long development timeline ahead
  • Significant clinical development and regulatory risks remain as an early-stage asset

Insights

Jazz's $42.5M upfront deal for Saniona's epilepsy drug SAN2355 could deliver significant long-term value with minimal near-term revenue impact.

Jazz Pharmaceuticals has secured exclusive global rights to Saniona's preclinical epilepsy asset SAN2355 through a substantial licensing deal worth $42.5 million upfront, with potential additional payments reaching $992.5 million plus tiered royalties. This strategic acquisition reinforces Jazz's commitment to expanding its neuroscience portfolio, particularly in epilepsy where the company already has established expertise.

The transaction's structure is particularly noteworthy. The $42.5 million upfront payment represents just 4.1% of the deal's total potential value, with the vast majority tied to development milestones ($192.5 million) and commercial performance ($800 million). This risk-adjusted approach minimizes Jazz's immediate financial exposure while maintaining significant upside if SAN2355 proves successful.

SAN2355's mechanism as a selective Kv7.2/Kv7.3 activator represents an important scientific approach. Unlike existing non-selective Kv7 activators which can cause significant side effects, SAN2355's subtype selectivity could potentially deliver improved efficacy with fewer adverse events - a critical differentiator in the competitive epilepsy market. While still in preclinical development, the compound's potential as a "best-in-class" therapy suggests Jazz sees compelling early data supporting its investment.

For Saniona, this deal provides crucial non-dilutive capital to advance other pipeline programs while leveraging Jazz's established development and commercialization capabilities. The $7.5 million milestone tied to Phase 1 initiation offers a relatively near-term catalyst for Saniona, assuming preclinical development proceeds without significant delays.

SAN2355's mechanism as a subtype-selective Kv7.2/Kv7.3 activator represents a potentially significant advancement in epilepsy treatment. Potassium voltage-gated (Kv7) channels play a crucial role in regulating neuronal excitability, making them important targets for anti-seizure medications. However, first-generation Kv7 modulators like ezogabine (retigabine) were hampered by off-target effects due to their non-selective activation across multiple Kv7 subtypes, leading to side effects including urinary retention and blue skin discoloration that ultimately limited clinical utility.

SAN2355's selective targeting of Kv7.2/Kv7.3 heteromeric channels - the specific subtypes most relevant to epilepsy - potentially addresses these limitations. These particular channel subtypes generate the neuronal M-current, which stabilizes resting membrane potential and regulates neuronal firing. By specifically enhancing this current in neurons without affecting other Kv7 subtypes found in cardiac tissue (Kv7.1) or other organ systems, SAN2355 could theoretically deliver anti-seizure efficacy with an improved safety profile.

While still in preclinical development, Jazz's substantial financial commitment suggests the compound has shown promising early results in relevant animal models. The company's experience with oxybate products for neurological conditions positions them well to navigate the complex development pathway for CNS drugs. The immediate research focus will likely involve completing IND-enabling studies including pharmacokinetics, toxicology assessments, and manufacturing scale-up, with first-in-human studies potentially beginning within 12-18 months based on the milestone structure.

Though not discussed in the release, SAN2355's potential may extend beyond epilepsy to other neurological conditions characterized by neuronal hyperexcitability, including neuropathic pain, certain psychiatric disorders, and potentially neurodegenerative diseases - providing multiple paths to maximize the asset's value.

Saniona to receive US $42.5 million upfront; potential for development, regulatory and sales milestone payments in addition to royalties on future net sales

Jazz obtains exclusive worldwide rights to develop and commercialize preclinical asset SAN2355 in epilepsy and other potential indications

For U.S. media and investors only

DUBLIN and COPENHAGEN, Denmark, Aug. 20, 2025 /PRNewswire/ --ÌýJazz Pharmaceuticals plc (Nasdaq: JAZZ) and Saniona (Nasdaq OMX: SANION) today announce that the companies have entered into a global license agreement for Jazz to obtain exclusive worldwide rights to develop SAN2355, a highly differentiated, subtype-selective Kv7.2/Kv7.3 activator in preclinical development for epilepsy and other potential indications, designed to overcome the limitations of non-selective Kv7-targeting compounds. Jazz will lead and fund further development, regulatory submissions, and global commercialization activities.

"Our collaboration with Jazz leverages their leading position in epilepsy and their strong track record of rapidly advancing clinical development programs and effectively commercializing novel therapies in neuroscience, positioning SAN2355 as a promising option for epilepsy and neurological conditions, while enabling us to advance several of our other valuable pipeline programs to key inflection points," said Thomas Feldthus, CEO of Saniona. "Jazz's commitment to develop life-changing medicines for people with serious diseases aligns with our mission to improve outcomes for those affected by neurological and psychiatric disorders, and both companies aim to expand treatment possibilities for patients in need."

"SAN2355 is a unique and highly promising preclinical asset that has the potential to become a best-in-class Kv7 activator for the treatment of epilepsy. We are pleased to enter this exclusive agreement with Saniona to lead the SAN2355 clinical development program," saidÌýRobert Iannone, M.D., M.S.C.E., executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals. "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."

Transaction Terms
Under the terms of the exclusive licensing agreement, Saniona will receive an upfront payment of US $42.5 million. Saniona is eligible to receive: up to US $192.5 million in development and regulatory milestones, including a US $7.5 million milestone payment upon initiation of the first Phase 1 clinical study; up to US $800 million in commercial milestone payments based on the achievement of significant and pre-specified annual net sales thresholds; and tiered royalties ranging from the mid-single digits to low-double digits on net sales of commercial products resulting from the development of SAN2355.

About SAN2355
SAN2355 is a preclinical, selective small molecule activator of Kv7.2/Kv7.3 potassium channels, a mechanism validated for seizure suppression. Prior Kv7-targeting agents have demonstrated clinical efficacy, but dosing appears to be limited by adverse events associated with off-target activation. SAN2355 is uniquely selective for Kv7.2/Kv7.3, the Kv7-subtypes responsible for seizure suppression, and avoids activation of other Kv7-subtypes. This selectivity enables SAN2355 to deliver dosing to optimal efficacy and supports its potential as a best-in-class treatment for epilepsy.

About Jazz PharmaceuticalsÌý
Jazz Pharmaceuticals plcâ€�(Nasdaq: JAZZ) is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing potentially life-changing medicines for people with serious diseases â€� often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visitâ€�www.jazzpharmaceuticals.com for more information.Ìý

About Saniona
Saniona is a clinical-stage biopharmaceutical company focused on discovering, developing, and delivering innovative treatments for neurological and psychiatric disorders. The company's internal pipeline includes SAN2219 for epilepsy and SAN2465 for major depressive disorder. Saniona has established strategic collaborations with leading pharmaceutical companies, including Jazz Pharmaceuticals, which holds global rights to SAN2355 for epilepsy, Acadia Pharmaceuticals, which holds worldwide rights to ACP-711 for essential tremor, and with Medix, which holds rights to tesofensine for obesity in Mexico and Argentina, where a market authorization application is currently under review. In addition, Saniona has two clinical-stage programs available for partnering: Tesometâ„�, ready to advance to Phase 2b trials in rare eating disorders, and SAN903, ready to enter Phase 1 trials in inflammatory bowel disease. Saniona's ion channel discovery platform is further validated through research collaborations with Boehringer Ingelheim, AstronauTx, and Cephagenix. Headquartered in Copenhagen, Saniona is listed on the Nasdaq Stockholm Main Market. For more information, visit .Ìý Ìý

Jazz PharmaceuticalsÌýplc Caution Concerning Forward-Looking StatementsÌý
This press release contains forward-looking statements, including, but not limited to, statements related to SAN2355's potential to be a best-in-class Kv7 activator for the treatment of epilepsy; the potential future development, manufacturing, regulatory and commercialization activities; potential future payments by Jazz Pharmaceuticals to Saniona for development, regulatory and commercial milestones as well as tiered royalties based on future net sales; and other statements that are not historical facts. These forward-looking statements are based on Jazz Pharmaceuticals' current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with: Jazz Pharmaceuticals' ability to achieve the expected benefits (commercial or otherwise) from the license agreement; pharmaceutical product development and clinical success thereof; the regulatory approval process; effectively commercializing any product candidates; and other risks and uncertainties affecting Jazz Pharmaceuticals, including the Company's Annual Report on Form 10-K for the year ended December 31, 2024, the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, and future filings and reports by the Company. Other risks and uncertainties of which Jazz Pharmaceuticals is not currently aware may also affect Jazz Pharmaceuticals' forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof or as of the dates indicated in the forward-looking statements, even if they are subsequently made available by Jazz Pharmaceuticals on its website or otherwise. Jazz Pharmaceuticals undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made.

Jazz Pharmaceuticals Contacts:Ìý

Investors:Ìý Ìý
Jack SpinksÌý
Executive Director, Investor Relations
Pharmaceuticals plc
[email protected] Ìý
Ireland +353 1 634 3211Ìý
U.S. +1 650 496 2717Ìý

Media Contact:
Kristin Bhavnani
Head of Global Corporate Communications
Jazz Pharmaceuticals plc
[email protected]
Ireland +353 1 637 2141
U.S. +1 215 867 4948Ìý

Saniona Contact:
Johnny Stilou
CFO
Saniona ABÌý
[email protected]Ìý
+45 21 227 227

Ìý

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SOURCE Jazz Pharmaceuticals plc

FAQ

What is the value of Jazz Pharmaceuticals' licensing agreement with Saniona for SAN2355?

Jazz will pay $42.5 million upfront, with potential milestone payments of up to $992.5 million plus tiered royalties ranging from mid-single digits to low-double digits on net sales.

What is SAN2355 and how does it work?

SAN2355 is a subtype-selective Kv7.2/Kv7.3 activator in preclinical development for epilepsy, designed to overcome limitations of non-selective Kv7-targeting compounds.

What development stage is JAZZ's new epilepsy drug SAN2355 in?

SAN2355 is currently in preclinical development. Jazz will receive a $7.5 million milestone payment upon initiation of the first Phase 1 clinical study.

Who will be responsible for developing and commercializing SAN2355?

Jazz Pharmaceuticals will lead and fund all further development, regulatory submissions, and global commercialization activities for SAN2355.

What are the milestone payments in the Jazz-Saniona agreement?

The agreement includes up to $192.5 million in development and regulatory milestones and up to $800 million in commercial milestone payments based on net sales thresholds.
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