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.
