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Relief Therapeutics Receives Notice of Allowance for European Patent Covering RLF-TD011 for Epidermolysis Bullosa Wound Treatment

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Relief Therapeutics has received a Notice of Allowance from the European Patent Office for its patent application covering RLF-TD011, a treatment for wounds caused by epidermolysis bullosa (EB). The patent, set to protect RLF-TD011 in key European countries until 2040, covers Relief's proprietary hypochlorous acid solutions. Corresponding applications are under review in other major markets, including the U.S. and China.

RLF-TD011 has previously received orphan drug designation from the U.S. FDA for EB, potentially providing incentives such as market exclusivity upon approval. Giorgio Reiner, Relief's chief scientific officer, stated that this patent grant validates their efforts to develop novel treatments for rare diseases and strengthens the protection of their innovation as they advance RLF-TD011's development.

Relief Therapeutics ha ricevuto un Avviso di Concessione dall'Ufficio Europeo dei Brevetti per la sua domanda di brevetto che riguarda RLF-TD011, un trattamento per le ferite causate da epidermolisi bollosa (EB). Il brevetto, che proteggerà RLF-TD011 in importanti paesi europei fino al 2040, copre le soluzioni proprietarie a base di acido ipocloroso di Relief. Domande corrispondenti sono attualmente in fase di revisione in altri mercati principali, tra cui gli Stati Uniti e la Cina.

RLF-TD011 ha già ricevuto la designazione di farmaco orfano dalla FDA statunitense per l'EB, il che può fornire incentivi come l'esclusività di mercato una volta approvato. Giorgio Reiner, il direttore scientifico di Relief, ha dichiarato che questo concessione di brevetto convalida i loro sforzi nello sviluppo di nuovi trattamenti per malattie rare e rafforza la protezione della loro innovazione mentre proseguono nello sviluppo di RLF-TD011.

Relief Therapeutics ha recibido un Aviso de Concesión de la Oficina Europea de Patentes para su solicitud de patente que cubre RLF-TD011, un tratamiento para heridas causadas por epidermólisis bullosa (EB). La patente, que protegerá RLF-TD011 en países europeos clave hasta 2040, cubre las soluciones proprietarias de ácido hipocloroso de Relief. Las solicitudes correspondientes están siendo revisadas en otros mercados importantes, incluidos los EE. UU. y China.

RLF-TD011 ha recibido anteriormente la designación de medicamento huérfano de la FDA de EE. UU. para la EB, lo que podría proporcionar incentivos como la exclusividad en el mercado tras su aprobación. Giorgio Reiner, director científico de Relief, declaró que esta concesión de patente valida sus esfuerzos para desarrollar tratamientos novedosos para enfermedades raras y refuerza la protección de su innovación mientras avanzan en el desarrollo de RLF-TD011.

Relief Therapeutics는 RLF-TD011에 대한 특허 출원을 유럽 특허청으로부터 허가 통지를 받았습니다. 이는 수포성 피부박리증(EB)으로 인한 상처 치료제입니다. 이 특허는 2040년까지 주요 유럽 국가에서 RLF-TD011을 보호할 예정이며, Relief의 독점적 희석산(acid)의 솔루션을 포함합니다. 미국 및 중국을 포함한 다른 주요 시장에서도 해당 출원이 검토 중입니다.

RLF-TD011은 이전에 EB에 대해 미국 FDA로부터 오른약 지정을 받아, 승인 시 시장 독점과 같은 인센티브를 제공할 수 있습니다. Relief의 수석 과학 책임자인 Giorgio Reiner는 이번 특허 부여가 희귀질환을 위한 혁신적인 치료법 개발을 위한 그들의 노력을 확인해주며, RLF-TD011의 개발을 진전시키면서 그들의 혁신을 보호하는 데에 도움이 된다고 밝혔습니다.

Relief Therapeutics a reçu un Avis de Concession de l'Office européen des brevets pour sa demande de brevet concernant RLF-TD011, un traitement pour les blessures causées par l'épidermolyse bulleuse (EB). Le brevet, qui doit protéger RLF-TD011 dans des pays européens clés jusqu'en 2040, couvre les solutions d'acide hypochloreux propriétaires de Relief. Des demandes correspondantes sont en cours d'examen dans d'autres marchés majeurs, y compris les États-Unis et la Chine.

RLF-TD011 a déjà reçu la désignation de médicament orphan de la FDA américaine pour l'EB, ce qui pourrait offrir des incitations telles que l'exclusivité du marché une fois approuvé. Giorgio Reiner, directeur scientifique de Relief, a déclaré que cette attribution de brevet valide leurs efforts pour développer des traitements novateurs pour les maladies rares et renforce la protection de leur innovation alors qu'ils poursuivent le développement de RLF-TD011.

Relief Therapeutics hat eine Erlaubnisbenachrichtigung vom Europäischen Patentamt für ihren Patentantrag bezüglich RLF-TD011 erhalten, einem Behandlungsmittel für Wunden, die durch Epidermolysis bullosa (EB) verursacht werden. Das Patent wird RLF-TD011 bis 2040 in wichtigen europäischen Ländern schützen und umfasst die proprietären hypochlorigen Säurelösungen von Relief. Entsprechende Anträge werden auch in anderen wichtigen Märkten, einschließlich der USA und China, geprüft.

RLF-TD011 erhielt zuvor die Orphan Drug Designation von der US FDA für EB, was potenziell Anreize wie Marktexklusivität nach der Genehmigung bieten kann. Giorgio Reiner, der wissenschaftliche Leiter von Relief, erklärte, dass diese Patenterteilung ihre Bemühungen zur Entwicklung neuartiger Behandlungen für seltene Krankheiten validiert und den Schutz ihrer Innovation stärkt, während sie die Entwicklung von RLF-TD011 vorantreiben.

Positive
  • Notice of Allowance received for European patent covering RLF-TD011
  • Patent protection in key European countries until 2040
  • Orphan drug designation from U.S. FDA for epidermolysis bullosa treatment
  • Potential for market exclusivity upon approval
Negative
  • None.

GENEVA, SWITZERLAND / ACCESSWIRE / October 21, 2024 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF)(OTCQB:RLFTY ) (Relief, or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, today reported that the European Patent Office (EPO) has issued a Notice of Allowance under Rule 71(3) EPC for Relief's patent application No. 20737588.2, titled "Therapeutic Uses of Oxidizing Hypotonic Acid Solutions." This Notice of Allowance signifies the EPO's intention to grant a patent covering Relief's proprietary, highly pure hypochlorous acid solutions, including its investigational drug RLF‑TD011 intended for the treatment of wounds caused by epidermolysis bullosa (EB).

Upon completion of the grant procedure, the patent will protect RLF-TD011 in key European countries until 2040. Corresponding applications in other major markets, including the U.S. and China, are currently under review. RLF-TD011 previously received orphan drug designation (ODD) from the U.S. Food and Drug Administration for EB, providing potential incentives such as market exclusivity upon approval.

Giorgio Reiner, chief scientific officer of Relief, said: "We are very pleased with this news. The anticipated grant of this patent represents an additional validation of our efforts to develop novel treatments for rare and devastating diseases like EB. This patent will strengthen the protection of our innovation as we continue advancing RLF-TD011's development, with the ultimate goal of reaching patients who need it most."

ABOUT RLF-TD011
RLF-TD011 is a highly pure, stabilized hypochlorous acid solution developed using Relief's proprietary TEHCLO™ technology. With strong antimicrobial properties, RLF-TD011 is a sprayable, self-administered solution for targeted wound application while avoiding skin contact and cross-contamination. RLF-TD011 has shown efficacy in accelerating wound closure and reducing infections in certain clinical trials on non-EB wounds. In preliminary cases, EB patients using RLF-TD011 showed improvements in blistering and tissue repair. Currently under clinical development, RLF-TD011 has the potential to offer an innovative solution for EB wound care management. The U.S. Food and Drug Administration granted it orphan drug designation for EB, and Relief plans to seek qualified infectious disease product (QIDP) designation for extended market exclusivity.

ABOUT EPIDERMOLYSIS BULLOSA
Epidermolysis bullosa (EB) is a group of rare, inherited connective tissue disorders characterized by extreme skin fragility, leading to blistering and wounds from minor friction or injury. In severe cases, blisters can develop into chronic wounds or form in internal organs such as the mouth or esophagus. EB affects approximately 1 in 20,000 births in the United States, while the global prevalence of epidermolysis bullosa simplex (EBS) ranges from 1 in 85,000 to 1 in 500,000.

ABOUT RELIEF
Relief is a commercial-stage biopharmaceutical company committed to advancing treatment paradigms and delivering improvements in efficacy, safety, and convenience to benefit the lives of patients living with select specialty and rare diseases. Relief's portfolio offers a balanced mix of marketed, revenue-generating products, proprietary, globally patented TEHCLO™ and Physiomimic™ platform technologies and a targeted clinical development pipeline consisting of risk-mitigated assets focused in three core therapeutic areas: rare skin diseases, rare metabolic disorders, and rare respiratory diseases. In addition, Relief is commercializing several legacy products via licensing and distribution partners. Headquartered in Geneva, Relief is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com .

CONTACT :
RELIEF THERAPEUTICS Holding SA
Jeremy Meinen
Chief Financial Officer
contact@relieftherapeutics.com

DISCLAIMER
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties, including its ability to achieve its corporate, development and commercial goals, and other factors which could cause the actual results, financial condition, performance or achievements of Relief to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. A number of factors, including those described in Relief's filings with the SIX Swiss Exchange and the U.S. Securities and Exchange Commission (SEC), could adversely affect Relief. Copies of Relief's filings with the SEC are available on the SEC EDGAR database at www.sec.gov . Relief does not undertake any obligation to update the information contained herein, which speaks only as of this date.

SOURCE: Relief Therapeutics Holding SA



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FAQ

What is the significance of the European Patent Office's Notice of Allowance for Relief Therapeutics (RLFTY)?

The Notice of Allowance signifies the EPO's intention to grant a patent for Relief's RLF-TD011, protecting the treatment for epidermolysis bullosa wounds in key European countries until 2040. This strengthens Relief's intellectual property position for their innovative treatment.

What is RLF-TD011 developed by Relief Therapeutics (RLFTY) used for?

RLF-TD011 is an investigational drug developed by Relief Therapeutics for the treatment of wounds caused by epidermolysis bullosa (EB), a rare genetic skin disorder.

Has Relief Therapeutics (RLFTY) received any designations from the FDA for RLF-TD011?

Yes, RLF-TD011 has received orphan drug designation (ODD) from the U.S. Food and Drug Administration for epidermolysis bullosa, which may provide incentives such as market exclusivity upon approval.

What is the expiration date of the European patent for Relief Therapeutics' (RLFTY) RLF-TD011?

The European patent for Relief Therapeutics' RLF-TD011 is set to protect the treatment in key European countries until 2040.

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