Appili Therapeutics Announces U.S. FDA Approval of LIKMEZ™ (ATI-1501) Metronidazole Oral Suspension

Rhea-AI Summary

FDA approves LIKMEZ as brand name for Metronidazole Oral Suspension, providing market exclusivity through 2039

Positive

• FDA approval of LIKMEZ is an important milestone for Appili, demonstrating their ability to develop and monetize opportunities
• LIKMEZ provides a convenient alternative for patients who have difficulty taking solid oral medicines

Negative

• None.

FDA approves LIKMEZ as the brand name for Metronidazole Oral Suspension (LIKMEZ is a Trademark of Saptalis Pharmaceuticals, LLC)

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

Patent coverage provides drug market exclusivity through at least 2039

HALIFAX, Nova Scotia--(BUSINESS WIRE)-- Appili Therapeutics Inc. (TSX:APLI; OTCQB: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense, today announced that its manufacturing and commercialization partner, Saptalis Pharmaceuticals, LLC (“Saptalis”) received approval from the U.S. Food and Drug Administration ("FDA”) for Metronidazole Oral Suspension 500mg/5mL (ATI-1501). ATI-1501, Appili’s liquid oral reformulation of the antibiotic metronidazole, has been licensed to Saptalis for commercialization in the U.S., 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 Don Cilla, Pharm.D., M.B.A., Appili’s President and CEO. “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 adds “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 for LIKMEZ,” said Polireddy Dondeti, Ph.D., President and CEO 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 frontline 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 presents treatment compliance challenges.

Appili expects to receive milestone payments and royalties from Saptalis based on this FDA approval and Saptalis’ 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 antiparasitic 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 epicenter of the global fight against infection. For more information, visit www.AppiliTherapeutics.com.

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 LIKMEZ^TM

LIKMEZ is the first and only FDA approved ready made suspension of metronidazole for the treatment of antimicrobial infections that addresses the unmet need in patients with dysphagia and avoids risks associated with drug compounding, and discontinuation related anti-microbial resistance.

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 22, 2023 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230925938803/en/

Media Contact:

Jenna McNeil, Corporate Affairs and Communications Manager

Appili Therapeutics

E: JMcNeil@AppiliTherapeutics.com

Investor Relations Contact:

Don Cilla, Pharm.D. M.B.A.

Appili Therapeutics

E: Info@AppiliTherapeutics.com

Source: Appili Therapeutics Inc.