Marinus Pharmaceuticals Further Strengthens Intellectual Property Estate with Method of Treatment Patent for ZTALMY® Titration Regimens
Marinus Pharmaceuticals has strengthened its intellectual property estate with a new U.S. patent for ZTALMY® (ganaxolone) oral titration regimens. The patent covers treatment for various epilepsy disorders, including CDKL5 deficiency disorder, tuberous sclerosis complex (TSC), and Lennox-Gastaut syndrome (LGS). It expires in September 2042.
The new patent (U.S. patent No. 12,115,169) further protects ZTALMY and supports Marinus' development and commercialization plans for ganaxolone in TSC and other areas of high unmet need. The company's patent portfolio reflects decades of research and scientific innovation, backed by robust data on ganaxolone's pharmacology and effective clinical dosing.
Marinus believes that the revised ganaxolone titration schedule has the potential to significantly impact tolerability, compliance, and lead to improved patient outcomes in various epilepsy disorders.
Marinus Pharmaceuticals ha rafforzato il suo patrimonio di proprietà intellettuale con un nuovo brevetto negli Stati Uniti per ZTALMY® (ganaxolone) schemi di titolazione orale. Il brevetto copre il trattamento di vari disturbi epilettici, inclusi il disturbo da carenza di CDKL5, il complesso di sclerosi tuberosa (TSC) e la sindrome di Lennox-Gastaut (LGS). Scade nel settembre 2042.
Il nuovo brevetto (brevetto statunitense n. 12.115.169) protegge ulteriormente ZTALMY e supporta i piani di sviluppo e commercializzazione di Marinus per il ganaxolone in TSC e in altre aree con esigenze insoddisfatte elevate. Il portafoglio brevetti dell'azienda riflette decenni di ricerca e innovazione scientifica, supportata da dati solidi sulla farmacologia del ganaxolone e sulle dosi cliniche efficaci.
Marinus crede che il nuovo programma di titolazione del ganaxolone possa avere un impatto significativo sulla tollerabilità, la compliance e portare a migliori risultati per i pazienti in vari disturbi epilettici.
Marinus Pharmaceuticals ha fortalecido su patrimonio de propiedad intelectual con una nueva patente en EE. UU. para ZTALMY® (ganaxolone) regímenes de titulación oral. La patente cubre el tratamiento de varios trastornos epilépticos, incluyendo el trastorno por deficiencia de CDKL5, el complejo de esclerosis tuberosa (TSC) y el síndrome de Lennox-Gastaut (LGS). Expira en septiembre de 2042.
La nueva patente (patente de EE. UU. No. 12.115.169) protege aún más a ZTALMY y respalda los planes de desarrollo y comercialización de Marinus para ganaxolone en TSC y otras áreas con una alta necesidad insatisfecha. El portafolio de patentes de la compañía refleja décadas de investigación e innovación científica, respaldada por datos sólidos sobre la farmacología de ganaxolone y la dosificación clínica efectiva.
Marinus cree que el nuevo cronograma de titulación de ganaxolone tiene el potencial de impactar significativamente la tolerancia, la adherencia y llevar a mejores resultados para los pacientes en varios trastornos epilépticos.
Marinus Pharmaceuticals는 ZTALMY® (가낙솔론) 경구 조정 요법에 대한 새로운 미국 특허로 지적 재산을 강화했습니다. 이 특허는 CDKL5 결핍 장애, 결절 경화증 복합체 (TSC), 렌녹스-가스타 증후군 (LGS)을 포함한 다양한 간질 장애의 치료를 다룹니다. 2042년 9월에 만료됩니다.
새로운 특허(미국 특허 번호 12,115,169)는 ZTALMY를 추가로 보호하고 TSC 및 높은 미충족 요구가 있는 다른 분야에서 가낙솔론의 개발 및 상용화 계획을 지원합니다. 회사의 특허 포트폴리오는 수십 년간의 연구와 과학적 혁신을 반영하며, 가낙솔론의 약리학 및 효과적인 임상 용법에 대한 강력한 데이터로 뒷받침됩니다.
Marinus는 수정된 가낙솔론 조정 일정이 다양한 간질 장애에서의 내약성, 복약 순응도에 상당한 영향을 미치고 환자의 결과를 향상시킬 수 있는 잠재력을 가지고 있다고 믿습니다.
Marinus Pharmaceuticals a renforcé son patrimoine de propriété intellectuelle avec un nouveau brevet américain pour ZTALMY® (ganaxolone) régimes de titration orale. Le brevet couvre le traitement de divers troubles épileptiques, y compris le trouble de déficience en CDKL5, le complexe de sclérose tubéreuse (TSC) et le syndrome de Lennox-Gastaut (LGS). Il expire en septembre 2042.
Le nouveau brevet (brevet américain n° 12.115.169) protège davantage ZTALMY et soutient les plans de développement et de commercialisation de Marinus pour ganaxolone dans TSC et d'autres domaines à forte demande non satisfaite. Le portefeuille de brevets de l'entreprise reflète des décennies de recherche et d'innovation scientifique, soutenues par des données solides sur la pharmacologie de ganaxolone et des doses cliniques efficaces.
Marinus estime que le nouveau calendrier de titration de ganaxolone a le potentiel d'avoir un impact significatif sur la tolérabilité, la conformité et d'améliorer les résultats des patients dans divers troubles épileptiques.
Marinus Pharmaceuticals hat sein geistiges Eigentum mit einem neuen US-Patent für ZTALMY® (Ganaxolon) orale Titrationsregime gestärkt. Das Patent umfasst die Behandlung verschiedener Epilepsieerkrankungen, einschließlich CDKL5-Mangelstörung, tuberöser Sklerosekomplex (TSC) und Lennox-Gastaut-Syndrom (LGS). Es läuft im September 2042 aus.
Das neue Patent (US-Patent Nr. 12,115,169) schützt ZTALMY weiter und unterstützt die Entwicklungs- und Kommerzialisierungspläne von Marinus für Ganaxolon in TSC und anderen Bereichen mit hohem unerfülltem Bedarf. Das Patentportfolio des Unternehmens spiegelt jahrzehntelange Forschung und wissenschaftliche Innovation wider, untermauert durch robuste Daten zur Pharmakologie von Ganaxolon und effektiven klinischen Dosierungen.
Marinus ist überzeugt, dass der überarbeitete Ganaxolon-Titrationsschema das Potenzial hat, die Verträglichkeit, Compliance und die Patientenoutcomes bei verschiedenen Epilepsieerkrankungen erheblich zu verbessern.
- New U.S. patent strengthens IP protection for ZTALMY® (ganaxolone)
- Patent covers treatment for multiple epilepsy disorders
- Patent extends protection until September 2042
- Supports development and commercialization plans for ganaxolone in TSC and other areas
- None.
Insights
This patent issuance significantly bolsters Marinus Pharmaceuticals' intellectual property portfolio for ZTALMY® (ganaxolone). The new patent, covering oral titration regimens for treating various epilepsy disorders, extends protection until September 2042. This is a substantial extension beyond the typical 20-year patent life, providing long-term market exclusivity.
The expanded coverage to include tuberous sclerosis complex (TSC) and Lennox-Gastaut syndrome (LGS) broadens the potential market for ZTALMY beyond its current approval for CDKL5 deficiency disorder. This strategic IP move aligns with Marinus' development pipeline and could facilitate label expansions.
The USPTO's recognition of the titration regimens as "markedly different" from prior art suggests potential improvements in drug administration, which could translate to better patient outcomes and market differentiation. This strengthened IP position may also enhance Marinus' attractiveness for partnerships or acquisitions in the competitive epilepsy therapeutics space.
This patent issuance is a positive development for Marinus Pharmaceuticals, potentially enhancing its long-term value proposition. The extended patent protection to 2042 for ZTALMY® significantly increases the product's lifecycle, which is important for pharmaceutical companies' revenue streams and valuation models.
With a current market cap of
Investors should note that while this patent bolsters Marinus' competitive position, the company still faces challenges typical of small biotechs, including cash burn and regulatory hurdles for label expansions. The improved IP estate may, however, make Marinus a more attractive partner or acquisition target for larger pharmaceutical companies looking to expand their neurology portfolios.
New
Marinus continues to grow its IP portfolio to protect its scientific innovation
“The new patent granted to Marinus further strengthens the IP protection of ZTALMY and supports our development and commercialization plans for ganaxolone in TSC and other areas of high unmet need, such as LGS,” said Scott Braunstein, M.D., Chairman and Chief Executive Officer of Marinus. “Our patent portfolio is the result of decades of research and scientific innovation, fortified by robust data on the pharmacology and effective clinical dosing of ganaxolone. We are pleased that the USPTO recognized that the claimed titration regimens are markedly different from prior titration regimens. We believe that this revised ganaxolone titration schedule has the potential to have a meaningful impact on tolerability, compliance, and lead to improved patient outcomes in a range of epilepsy disorders.”
About Marinus Pharmaceuticals
Marinus is a commercial-stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders. The Company’s product, ZTALMY® (ganaxolone) oral suspension CV, is an FDA-approved prescription medication introduced in the
Forward-Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding Marinus, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "may", "will", "expect", "anticipate", "estimate", "intend", "believe", and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Examples of forward-looking statements contained in this press release include, among others, our expectation that the new intellectual property for ganaxolone that covers the titration regimen will support development of additional indications for use of ZTALMY and has the potential to have a meaningful impact on tolerability, compliance, and lead to improved patient outcomes in a range of epilepsy disorders, as well as other statements regarding our strategy, development plans and timelines and other future events.
Forward-looking statements in this press release involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the company’s ability to protect its intellectual property; unexpected actions by the FDA or other regulatory agencies with respect to our product candidates or products; competitive conditions and unexpected adverse events or patient outcomes from being treated with ZTALMY, uncertainties and delays relating to the design, enrollment, completion, and results of clinical trials; unanticipated costs and expenses; the company’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated; the timing of regulatory filings for our product candidates; clinical trial results may not support regulatory approval or further development in a specified indication or at all; actions or advice of the FDA or EMA may affect the design, initiation, timing, continuation and/or progress of clinical trials or result in the need for additional clinical trials; the size and growth potential of the markets for the company’s product candidates, and the company’s ability to service those markets; delays, interruptions or failures in the manufacture and supply of our product candidates; and the company’s ability to obtain additional funding to support its clinical development and commercial programs. This list is not exhaustive and these and other risks are described in our periodic reports, including our annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at www.sec.gov. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241015820494/en/
Investors
Sonya Weigle
Chief People and Investor Relations Officer
Marinus Pharmaceuticals, Inc.
sweigle@marinuspharma.com
Media
Molly Cameron
Director, Corporate Communications & Investor Relations
Marinus Pharmaceuticals, Inc.
mcameron@marinuspharma.com
Source: Marinus Pharmaceuticals
FAQ
What new patent did Marinus Pharmaceuticals (MRNS) receive for ZTALMY®?
When does the new ZTALMY® patent for Marinus Pharmaceuticals (MRNS) expire?
What epilepsy disorders does the new ZTALMY® patent for Marinus Pharmaceuticals (MRNS) cover?
How does the new patent benefit Marinus Pharmaceuticals (MRNS)?
