Lipella Pharmaceuticals Secures Extended Market Exclusivity with Issuance of U.S. Patent for Liposomal Delivery Platform
Lipella Pharmaceuticals (Nasdaq: LIPO) announced the issuance of U.S. Patent No. 12,138,345 for its proprietary liposomal drug delivery platform. The patent, titled 'Delivery of Agents Using Metastable Liposomes,' extends market exclusivity for the company's lead clinical assets, LP-10 and LP-310, currently in Phase 2 trials. LP-10 is a liposomal formulation of tacrolimus for hemorrhagic cystitis, while LP-310 is an oral rinse for oral lichen planus. The company holds additional patents in the United States, Australia, and Canada, providing exclusivity until 2035.
Lipella Pharmaceuticals (Nasdaq: LIPO) ha annunciato il rilascio del brevetto statunitense n. 12.138.345 per la sua piattaforma proprietaria di somministrazione di farmaci liposomali. Il brevetto, intitolato 'Somministrazione di agenti utilizzando liposomi metastabili', estende l'esclusività di mercato per i principali asset clinici dell'azienda, LP-10 e LP-310, attualmente in fase di sperimentazione di Fase 2. LP-10 è una formulazione liposomiale di tacrolimus per la cistite emorragica, mentre LP-310 è un collutorio per il lichen planus orale. L'azienda detiene ulteriori brevetti negli Stati Uniti, in Australia e in Canada, fornendo esclusività fino al 2035.
Lipella Pharmaceuticals (Nasdaq: LIPO) anunció la emisión de la patente estadounidense No. 12,138,345 para su plataforma propietaria de liberación de fármacos liposomales. La patente, titulada 'Entrega de agentes usando liposomas metastables', extiende la exclusividad de mercado para los principales activos clínicos de la compañía, LP-10 y LP-310, actualmente en ensayos de Fase 2. LP-10 es una formulación liposomal de tacrolimus para la cistitis hemorrágica, mientras que LP-310 es un enjuague bucal para el liquen plano oral. La compañía posee patentes adicionales en Estados Unidos, Australia y Canadá, proporcionando exclusividad hasta 2035.
리펠라 제약 (Nasdaq: LIPO)는 독자적인 리포좀 약물 전달 플랫폼에 대한 미국 특허 번호 12,138,345 발급을 발표했습니다. '메타스테이블 리포좀이용 약제의 전달'이라는 제목의 이 특허는 회사의 주요 임상 자산인 LP-10과 LP-310에 대한 시장 독점권을 연장합니다. LP-10은 출혈성 방광염에 대한 타크롤리무스의 리포좀 제형이며, LP-310은 구강 편평 태선에 대한 구강 세척제입니다. 이 회사는 미국, 호주 및 캐나다에서 추가 특허를 보유하고 있으며, 이는 2035년까지 독점권을 제공합니다.
Lipella Pharmaceuticals (Nasdaq: LIPO) a annoncé l'octroi du brevet américain n° 12,138,345 pour sa plateforme propriétaire de distribution de médicaments liposomaux. Le brevet, intitulé 'Distribution d'agents à l'aide de liposomes métastables', prolonge l'exclusivité sur le marché des principaux actifs cliniques de l'entreprise, LP-10 et LP-310, actuellement en essais de phase 2. LP-10 est une formulation liposomale de tacrolimus pour la cystite hémorragique, tandis que LP-310 est un rinçage buccal pour le lichen plan oral. L'entreprise détient d'autres brevets aux États-Unis, en Australie et au Canada, offrant une exclusivité jusqu'en 2035.
Lipella Pharmaceuticals (Nasdaq: LIPO) gab die Erteilung des US-Patents Nr. 12,138,345 für seine proprietäre liposomale Arzneimittelabgabetechnologie bekannt. Das Patent mit dem Titel 'Abgabe von Wirkstoffen unter Verwendung von metastabilen Liposomen' verlängert die Marktexklusivität für die Hauptprodukte des Unternehmens, LP-10 und LP-310, die sich derzeit in einer Phase-2-Studie befinden. LP-10 ist eine liposomale Formulierung von Tacrolimus zur Behandlung der hämorrhagischen Zystitis, während LP-310 ein Mundspülmittel für orale Lichen planus ist. Das Unternehmen hält weitere Patente in den Vereinigten Staaten, Australien und Kanada, die bis 2035 Exklusivität bieten.
- Patent issuance extends market exclusivity for lead products LP-10 and LP-310
- International patent protection secured until 2035 in US, Australia, and Canada
- Two products currently advancing in Phase 2 clinical trials
- None.
Insights
The newly issued patent significantly strengthens Lipella's competitive position in the liposomal drug delivery space. The technology's broad protection for metastable liposomes creates a robust barrier to entry for competitors until 2035. The platform's application in both LP-10 and LP-310 programs demonstrates versatility across different therapeutic areas.
The patent's timing aligns well with the ongoing Phase 2 trials of both lead candidates. LP-10's focus on hemorrhagic cystitis and LP-310's targeting of oral lichen planus addresses substantial unmet medical needs. The enhanced drug delivery system could potentially improve the therapeutic index of tacrolimus, reducing systemic exposure while maintaining local efficacy.
The extended market exclusivity and multi-country patent protection create a solid foundation for potential partnerships or licensing opportunities, particularly valuable for a company with a
PITTSBURGH, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO), a clinical-stage biotechnology company focused on developing innovative therapies for serious diseases with unmet medical needs, today announced that U.S. Patent No. 12,138,345 for its proprietary liposomal drug delivery platform will be officially issued by the U.S. Patent and Trademark Office (USPTO) on November 12, 2024. This patent, titled "Delivery of Agents Using Metastable Liposomes," covers key technological innovations that enable the targeted delivery of therapeutic agents using liposome-based vehicles.
The patent’s claims cover Lipella’s method of using metastable liposomes to deliver therapeutic agents, providing broad intellectual property protection for the company’s drug delivery platform. This protection extends market exclusivity for Lipella’s two lead clinical assets, LP-10 and LP-310, which are currently in Phase 2 clinical trials. LP-10, a liposomal formulation of tacrolimus for treating hemorrhagic cystitis, and LP-310, an oral rinse for managing oral lichen planus, represent promising new approaches to addressing diseases with limited treatment options.
“We believe our proprietary liposomal drug delivery platform holds significant potential to enhance efficacy and tolerability across various therapeutic areas, including oncology, cancer survivorship and immunotherapy. This platform offers a safer, more effective way to administer therapeutics like tacrolimus, providing patients with targeted treatment options that minimize side effects,” said Dr. Michael Chancellor, Chief Medical Officer of Lipella Pharmaceuticals. “The official issuance of this strategically important patent marks a pivotal advancement for Lipella, strengthening our intellectual property portfolio and supporting our commitment to advancing treatments for critical conditions such as hemorrhagic cystitis and oral lichen planus.”
With additional patents in the United States, Australia and Canada extending exclusivity until 2035, Lipella Pharmaceuticals is committed to providing value as it advances its clinical pipeline and explores new therapeutic applications.
About Lipella’s Lead Clinical Assets: LP-10 and LP-310
- LP-10 is a liposomal formulation of tacrolimus designed for intravesical administration to treat hemorrhagic cystitis (HC), a rare but severe condition characterized by bleeding from the bladder. LP-10 has shown promising safety and efficacy results in a multicenter Phase 2a trial, where it improved urinary symptoms in patients. The FDA has granted Orphan Drug Designation to LP-10 for the treatment of moderate to severe HC, further underscoring its potential to address this critical unmet need. A Phase 2b multicenter placebo-controlled trial is ready to begin.
- LP-310 is an innovative oral rinse formulation of LP-10, designed to treat oral lichen planus (OLP), a chronic autoimmune disease affecting the mucous membranes of the mouth. LP-310 offers a promising new approach to treating OLP, which affects millions of Americans and currently lacks an approved pharmacotherapy. A Phase 2a multicenter trial is underway with anticipated top-line data by year-end and trial completion by mid-2025. To find out more about our clinical trial visit: https://lipella.com/oral-lichen-planus-treatment/
About Lipella Pharmaceuticals Inc.
Lipella Pharmaceuticals is a clinical-stage biotechnology company focused on developing new drugs by reformulating active agents in existing generic drugs and optimizing these reformulations for new applications. Lipella targets diseases with significant unmet needs, where no approved drug therapies currently exist. The company completed its initial public offering in December 2022. Learn more at lipella.com and follow us on X and LinkedIn.
CONTACT
Jeff Ramson
PCG Advisory
jramson@pcgadvisory.com
646-863-6893
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