Dr. Don Cilla reports
APPILI THERAPEUTICS ANNOUNCES U.S. FDA APPROVAL OF LIKMEZ (ATI-1501) METRONIDAZOLE ORAL SUSPENSION
Appili Therapeutics Inc.'s manufacturing and commercialization partner, Saptalis Pharmaceuticals LLC, has received approval from the U.S. Food and Drug Administration (FDA) for metronidazole oral suspension 500 milligrams/five millilitres (ATI-1501). ATI-1501, Appili's liquid oral reformulation of the antibiotic metronidazole, has been licensed to Saptalis for commercialization in the United States and other selected territories. The FDA also approved Likmez as the brand name for ATI-1501.
"The FDA approval of Likmez, shortly after securing patent coverage through 2039, is an important milestone that demonstrates Appili's ability to identify promising opportunities and develop and monetize them for the benefit of both patients and shareholders," said Dr. Don Cilla, PharmD, MBA, Appili's president and chief executive officer. "Difficulty swallowing tablets and capsules should not be a barrier to accessing appropriate antibiotic therapy. Likmez provides a convenient alternative for patients who have difficulty taking solid oral medicines." Dr. Cilla added: "Appili was formed to develop ATI-1501 and it is exciting to see our first development project make it to market. This is a tremendous team accomplishment. We are all delighted that the product will soon be available to patients and we look forward to bringing additional products to market that tackle serious global challenges in infectious disease."
"We are pleased with the approval of the NDA [new drug application] for Likmez," said Dr. Polireddy Dondeti, PhD, president and chief executive officer at Saptalis. "We are proud of our team, which, using Appili's taste masking technology, has successfully developed a commercial product approved by the FDA. Likmez will address a clear market need in a more convenient dosage form of metronidazole, and we are prepared to initiate marketing and distribution activities in the very near future."
Metronidazole is a widely used front line oral treatment with over 10 million prescriptions written in the United States every year to help treat parasitic and anaerobic bacterial infections. The current tablet form of metronidazole is the only other approved oral form on the U.S. market, but its bitter taste and lack of appropriate dosage forms for patients with difficulty swallowing often present treatment compliance challenges.
Appili expects to receive milestone payments and royalties from Saptalis based on this FDA approval and Saptalis's commercialization plans.
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 a vaccine candidate to eliminate a serious biological weapon threat, a topical anti-parasitic for the treatment of a disfiguring disease, and a novel easy-to-use, liquid oral formulation targeting parasitic and anaerobic infections. Led by a proven management team, Appili is at the epicentre of the global fight against infection.
Likmez is the first and only FDA-approved ready-made suspension of metronidazole for the treatment of anti-microbial infections that addresses the unmet need in patients with dysphagia and avoids risks associated with drug compounding and discontinuation-related anti-microbial resistance.
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