Appili Therapeutics Secures New Patents for LIKMEZ®

Appili Therapeutics Inc., a company focusing on infectious disease treatments and medical countermeasures, has announced the acquisition of new patents from the United States Patent and Trademark Office and the Mexican Patent Office. These patents pertain to the company's oral formulation of metronidazole, known as LIKMEZ®. This development bolsters the intellectual property protection around LIKMEZ by covering its distinctive taste-masked composition and its therapeutic applications.

The newly granted U.S. patent, numbered 20230086660A1, along with the Mexican patent number 2020007494, secures these provisions until 2039. LIKMEZ, specifically designed to improve drug adherence through enhanced stability and palatability, provides a significant advantage in treating infections. These advancements are crucial for patients, particularly those facing challenges with medication compliance.

In collaboration with its partner, Saptalis Pharmaceuticals, LLC, the U.S. patent has been successfully listed in the FDA's Orange Book. This listing offers additional security for the product's unique taste-masking technology and aids Saptalis in its commercialization efforts. As Saptalis plans to re-launch LIKMEZ in May under its own label, the timing is favorable for their renewed marketing strategy.

Dr. Don Cilla, President and CEO of Appili Therapeutics, expressed satisfaction with this achievement, highlighting the innovative efforts of their research and development team. He emphasized that securing these patents shortly after LIKMEZ's U.S. introduction underscores the company's commitment to developing products that benefit both patients and stakeholders.

Polireddy Dondeti, President and CEO of Saptalis, also remarked on the strategic importance of the newly issued patent for LIKMEZ. The Orange Book listing will not only offer additional protection but will also facilitate Saptalis' product commercialization activities.

LIKMEZ is noteworthy for being the first FDA-approved ready-made suspension of metronidazole. It addresses the unmet needs of patients with swallowing difficulties and mitigates risks associated with drug compounding and antimicrobial resistance. This formulation is a significant advancement in the treatment of resistant infections, benefiting those who require an easily administered medication form.

Saptalis Pharmaceuticals, a rapidly expanding company, specializes in the development and commercialization of both generic and innovative liquid and semi-solid dosage forms. Their facilities, located in the Hauppauge Industrial Park, New York, are equipped to meet the FDA's current Good Manufacturing Practice (cGMP) requirements.

Appili Therapeutics, meanwhile, remains dedicated to addressing life-threatening infections with a portfolio-driven approach. By focusing on urgent and unmet medical needs, Appili aims to develop a pipeline of novel therapies to improve patient outcomes worldwide. The company is advancing various anti-infective treatments, including a vaccine candidate to counter biological threats and a topical antiparasitic for treating disfiguring diseases.

In summary, the new patents granted to Appili Therapeutics for their LIKMEZ formulation signify a vital step in strengthening the drug's market position and ensuring its continued availability for patients in need. The collaboration with Saptalis Pharmaceuticals further enhances the potential success of LIKMEZ in the pharmaceutical market.