PIPELINE

LIKMEZ™ (ATI-1501)

Commercial rights to LIKMEZ™ (Trademark of Saptalis Pharmaceuticals, LLC) for the United States, Europe and Latin America markets have been licensed to Saptalis, a R&D-driven pharmaceutical company focused on development and commercialization of complex niche products including oral suspensions. 

Appili will be eligible to receive royalties on the sale of LIKMEZ in these territories for a specified term, in addition to milestone payments and royalties on sales in the United States. Learn more about LIKMEZ below.

U.S. 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.

Metronidazole is a widely used front-line oral treatment with over 10 million prescriptions written in the United States every year. It is used to treat parasitic and anaerobic bacterial infections, which heavily burden elderly patients.

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 presents treatment compliance challenges.

Currently LIKMEZ is the only liquid oral suspension of metronidazole approved in the U.S.

Reduced adherence to the tablet oral form has been linked to increased rates of treatment failure, infection recurrence, and antibiotic resistance. For patients, this can lead to protracted, worsening illnesses and increased potential for infecting others. It can also increase the burden on the caregivers who support these patients.

Along with our partners, LIKMEZ was developped to fill this significant gap in the treatment paradigm with a taste-masked metronidazole liquid suspension.  

“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.” 

 

Appili President and CEO, Don Cilla, PharmD, MBA

If a patient fails on the oral tablet form of metronidazole, physicians often switch to another class of antibiotics. Healthcare practitioners must limit the use of second- and third-line antibiotic options:

  1. These antibiotics are typically more expensive, and limiting their use helps insurers manage healthcare costs.
  2. The more powerful antibiotics are typically held in reserve to minimize resistance development, a paradigm referred to as ‘stewardship.’ If used indiscriminately, many antibiotics that are effective today could quickly be undermined by increasingly resistant disease.

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

LIKMEZ was designed to enable broader use of metronidazole among patients with difficulty swallowing. We are pleased to be able to provide a solution with the same safety and efficacy profile provided by metronidazole for 50 years, that is both easy to swallow and good tasting, thereby helping patients to adhere with their medication and improve their prognoses.

Being able to increase the number of patients who can benefit from this safe, effective, and widely used front-line antibiotic ultimately supports healthcare cost containment and antibiotic stewardship initiatives.

Our goal is to help patients and their healthcare providers address a significant unmet medical need, while ensuring broad market access, and the potential for our investors to realize the value of this asset.

The approval of this product, with the brand name of LIKMEZ, entitles Appili to receive royalties and milestone payments from its partner Saptalis, based on their commercialization plans. 

IQVIATM 2014-2017 NPA, ‘metronidazole’; IQVIATM 2016-2017 CDM, ‘metronidazole’

Hoppe (1996) Pharmacoeconomics:
https://www.ncbi.nlm.nih.gov/pubmed/10164058