Appili Therapeutics Announces New Patents Granted for Commercial Stage Asset LIKMEZ®™
Appili Therapeutics (TSX: APLI; OTCPink: APLIF) has secured new patents in the United States and Mexico for LIKMEZ, its oral formulation of metronidazole. The patents, expiring in 2039, protect the drug's unique taste-masked composition and therapeutic applications.
The U.S. patent (20230086660A1) and Mexican patent (2020007494) have been granted for 'Oral Formulations of Metronidazole and Methods of Treating an Infection Using Same.' Notably, Saptalis Pharmaceuticals, Appili's partner, has successfully listed the U.S. patent in the FDA's Orange Book.
Saptalis plans to re-launch LIKMEZ under its own label in May 2025. The drug's proprietary formulation offers improved stability and palatability, which are important factors for patient medication adherence and better treatment outcomes.
Appili Therapeutics (TSX: APLI; OTCPink: APLIF) ha ottenuto nuovi brevetti negli Stati Uniti e in Messico per LIKMEZ, la sua formulazione orale di metronidazolo. I brevetti, con scadenza nel 2039, proteggono la composizione unica con mascheramento del gusto e le applicazioni terapeutiche del farmaco.
Il brevetto statunitense (20230086660A1) e quello messicano (2020007494) sono stati concessi per le 'Formulazioni Orali di Metronidazolo e Metodi per Trattare un’Infezione Utilizzandole.' Da notare che Saptalis Pharmaceuticals, partner di Appili, ha inserito con successo il brevetto USA nell’Orange Book della FDA.
Saptalis prevede di rilanciare LIKMEZ con il proprio marchio a maggio 2025. La formulazione proprietaria del farmaco offre una maggiore stabilità e gradevolezza al palato, fattori chiave per migliorare l’aderenza alla terapia e i risultati del trattamento.
Appili Therapeutics (TSX: APLI; OTCPink: APLIF) ha asegurado nuevas patentes en Estados Unidos y México para LIKMEZ, su formulación oral de metronidazol. Las patentes, que expiran en 2039, protegen la composición única con enmascaramiento del sabor y las aplicaciones terapéuticas del medicamento.
La patente estadounidense (20230086660A1) y la mexicana (2020007494) han sido otorgadas por 'Formulaciones Orales de Metronidazol y Métodos para Tratar una Infección Usándolas.' Cabe destacar que Saptalis Pharmaceuticals, socio de Appili, ha logrado listar la patente estadounidense en el Orange Book de la FDA.
Saptalis planea relanzar LIKMEZ bajo su propia marca en mayo de 2025. La formulación exclusiva del medicamento ofrece mayor estabilidad y palatabilidad, factores importantes para la adherencia del paciente al tratamiento y mejores resultados terapéuticos.
Appili Therapeutics (TSX: APLI; OTCPink: APLIF)는 경구용 메트로니다졸 제제인 LIKMEZ에 대해 미국과 멕시코에서 새로운 특허를 획득했습니다. 2039년까지 유효한 이 특허들은 약물의 독특한 맛 차단 조성물과 치료적 용도를 보호합니다.
미국 특허(20230086660A1)와 멕시코 특허(2020007494)는 '메트로니다졸 경구 제제 및 이를 이용한 감염 치료 방법'에 대해 승인되었습니다. 특히, Appili의 파트너인 Saptalis Pharmaceuticals가 미국 특허를 FDA의 오렌지 북에 성공적으로 등재했습니다.
Saptalis는 2025년 5월 자체 브랜드로 LIKMEZ를 재출시할 계획입니다. 이 약물의 독점 제형은 안정성과 맛 개선을 제공하여 환자의 복약 순응도와 치료 효과 향상에 중요한 역할을 합니다.
Appili Therapeutics (TSX : APLI ; OTCPink : APLIF) a obtenu de nouveaux brevets aux États-Unis et au Mexique pour LIKMEZ, sa formulation orale de métronidazole. Ces brevets, expirant en 2039, protègent la composition unique masquant le goût ainsi que les applications thérapeutiques du médicament.
Le brevet américain (20230086660A1) et le brevet mexicain (2020007494) ont été délivrés pour les « Formulations orales de métronidazole et méthodes de traitement d’une infection les utilisant ». Notamment, Saptalis Pharmaceuticals, partenaire d’Appili, a réussi à inscrire le brevet américain dans l’Orange Book de la FDA.
Saptalis prévoit de relancer LIKMEZ sous sa propre marque en mai 2025. La formulation exclusive du médicament offre une meilleure stabilité et une meilleure palatabilité, des facteurs essentiels pour l’adhésion des patients au traitement et de meilleurs résultats thérapeutiques.
Appili Therapeutics (TSX: APLI; OTCPink: APLIF) hat in den USA und Mexiko neue Patente für LIKMEZ, seine orale Metronidazol-Formulierung, gesichert. Die Patente, die bis 2039 gültig sind, schützen die einzigartige geschmacksüberdeckende Zusammensetzung und die therapeutischen Anwendungen des Medikaments.
Das US-Patent (20230086660A1) und das mexikanische Patent (2020007494) wurden für 'Orale Formulierungen von Metronidazol und Methoden zur Behandlung einer Infektion mit diesen' erteilt. Bemerkenswert ist, dass Saptalis Pharmaceuticals, Appilis Partner, das US-Patent erfolgreich im Orange Book der FDA eingetragen hat.
Saptalis plant, LIKMEZ im Mai 2025 unter eigener Marke neu auf den Markt zu bringen. Die proprietäre Formulierung des Medikaments bietet verbesserte Stabilität und Geschmack, was wichtige Faktoren für die Therapietreue der Patienten und bessere Behandlungsergebnisse sind.
- New patent protection extended until 2039 for LIKMEZ
- Successfully listed in FDA's Orange Book, strengthening market position
- Planned commercial relaunch in May 2025
- None.
New patents provide additional composition of matter and methods of use claims, strengthening the protection for liquid oral taste-masked reformulation, LIKMEZ
New subject matter listed in the U.S. Food and Drug Administration’s (“FDA”) Orange Book
HALIFAX, Nova Scotia, April 28, 2025 (GLOBE NEWSWIRE) -- Appili Therapeutics Inc. (TSX: APLI; OTCPink: APLIF) (the “Company” or "Appili"), a biopharmaceutical company focused on drug development for infectious diseases and medical countermeasures, today announced the United States Patent and Trademark Office and the Mexican Patent Office have granted new patent claims protecting its oral formulation of metronidazole, LIKMEZ®™.
The newly granted patents include:
- U.S. patent no. 20230086660A1 - Oral Formulations of Metronidazole and Methods of Treating an Infection Using Same
- Mexican patent no. 2020007494 - Oral Formulations of Metronidazole and Methods of Treating an Infection Using Same
The two new patents, set to expire in 2039 provide comprehensive protection for LIKMEZ, covering its unique taste masked composition and accessible therapeutic applications. Our partner, Saptalis Pharmaceuticals, LLC, has successfully undertaken the necessary steps to have the U.S. patent listed in the FDA Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
"Our proprietary formulation of metronidazole offers improved stability and palatability - key factors in helping patients adhere to their medications and improve treatment outcomes," said Dr. Don Cilla, President and Chief Executive Officer at Appili Therapeutics. "Securing additional patents, shortly after launching LIKMEZ in the U.S., is a significant achievement that demonstrates the creativity of Appili’s R&D team, and reinforces our commitment to developing products for the benefit of patients and shareholders."
“We are pleased with the issuance of the new patent for LIKMEZ,” said Polireddy Dondeti, Ph.D., President and Chief Executive Officer at Saptalis. “The listing of the patent in the Orange Book will ensure additional protection of the unique taste masking technology used in LIKMEZ formulation and support Saptalis’ team product commercialization activities. The timing of the listing is especially beneficial, as Saptalis is planning to re-launch LIKMEZ in May of this year under its own label.”
About LIKMEZ ®™
LIKMEZ ®™ is the first and only FDA approved ready made suspension of metronidazole for the treatment of antimicrobial resistant infections that addresses the unmet need in patients with dysphagia and avoids risks associated with drug compounding, and discontinuation related anti-microbial resistance.
About Saptalis Pharmaceuticals, LLC
Saptalis Pharmaceuticals, LLC is a rapidly growing pharmaceutical company specialized in development, manufacturing, and commercialization of generic and innovative products in liquid and semi-solid dosage forms.
Located in the Hauppauge Industrial Park on Long Island, NY, USA, Saptalis has fully equipped Research & Development Laboratories and state of the art commercial scale manufacturing facility designed to meet FDA cGMP requirements. For more information, visit www.Saptalis.com.
About Appili Therapeutics
Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili’s goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. The Company is currently advancing a diverse range of anti-infectives, including an FDA approved ready-made suspension of metronidazole for the treatment of antimicrobial infections, a vaccine candidate to eliminate a serious biological weapon threat, and a topical antiparasitic for the treatment of a disfiguring disease. Led by a proven management team, Appili is at the epicenter of the global fight against infection. For more information, visit www.AppiliTherapeutics.com.
Forward looking statements
This news release contains “forward-looking statements”, including with respect to the commercialization plans for LIKMEZ and the timing of any milestone and/or royalty payments in respect to ATI-1501. Wherever possible, words such as “may,” “would,” “could,” “should,” “will,” “anticipate,” “believe,” “plan,” “expect,” “intend,” “estimate,” “potential for” and similar expressions have been used to identify these forward-looking statements. Forward-looking statements contained in this press release are provided in reliance on certain assumptions, including with respect to the commercialization plans for LIKMEZ. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, the Company cannot give assurance that these expectations will prove to have been correct.
Forward looking statements involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, customary risk relating to the development and commercialization of LIKMEZ which may have an impact on the quantum and timing of any milestone payments to the Company, and the other risk factors listed in the annual information form of the Company dated June 25, 2024 and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedarplus.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law.
Media Contact:
Jenna McNeil, Communications Manager
Appili Therapeutics
E: JMcNeil@AppiliTherapeutics.com
Investor Relations:
Don Cilla, President and CEO
Appili Therapeutics
E: Info@AppiliTherapeutics.com
FAQ
What new patents has Appili Therapeutics (APLIF) received for LIKMEZ in 2025?
When will Saptalis Pharmaceuticals relaunch LIKMEZ under its own label?
What are the key benefits of LIKMEZ's formulation according to Appili Therapeutics?
How does the FDA Orange Book listing benefit LIKMEZ's patent protection?
