Agreement expanded to add European and Latin American markets
NDA filing with US FDA for Appili’s ATI-1501 expected later this year
Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases, announced today it has amended its agreement with Saptalis Pharmaceuticals LLC (“Saptalis”), a New York-based specialty pharmaceuticals company, to expand the territories in which Saptalis will commercialize ATI-1501, Appili’s liquid oral reformulation of the antibiotic metronidazole. Under the terms of the amended agreement, Saptalis will assume responsibility for development and commercialization of ATI-1501 in Europe and Latin America (collectively, the “Expanded Territories”). Appili will be eligible to receive royalties on the sale of ATI-1501 in the Expanded Territories for a specified term, in addition to milestone payments and royalties on sales in the United States described in the original agreement.
Metronidazole is a broad-spectrum antibiotic widely used for the treatment of parasitic and anaerobic bacterial infections. Although oral metronidazole is heavily prescribed globally there are no or few liquid oral dose formulations in many countries around the world, in part due to challenges managing metronidazole’s pronounced bitter taste. Saptalis and Appili are developing ATI-1501 to provide a ready-to-use, taste-masked liquid oral dose form of metronidazole for the growing number of patients with difficulty swallowing.
Saptalis is planning to complete all remaining development activities to support a New Drug Application (“NDA”) submission to the United States Food and Drug Administration (“FDA”) later this year. Appili has agreed to fund a portion of the remaining clinical development activities to support such NDA filing.
Appili recently invoiced a milestone payment for the successful manufacture and stability of ATI-1501 registration batches and expects to receive additional development milestone payments in 2022 based on Saptalis’ proposed NDA submission timeline.
“Difficulty swallowing tablets and capsules should not be a barrier to accessing appropriate antibiotic therapy. We are proud to be working with Saptalis to make metronidazole more accessible and easier to take for all patients, in particular elderly patients and children who sometimes have difficulty taking solid oral medicines,” said Dr. Armand Balboni, Chief Executive Officer, Appili Therapeutics. “Saptalis has proven to be the ideal partner for ATI-1501. Their expertise in novel formulations has helped us overcome various manufacturing challenges and puts us on track for a NDA submission in 2022. We also share a global vision for ATI-1501 and are excited to be expanding our commercialization agreement to reach more patients in need.”
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 a broad-spectrum antifungal, a vaccine candidate to eliminate a serious biological weapon threat, and two novel antibiotic programs. 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 expected development plan for ATI-1501, the filing of the NDA and the timing and eligibility of various milestone and royalty payments. 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. These forward-looking statements reflect the current expectations of the Company’s management for future growth, results of operations, performance and business prospects and opportunities and involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, those listed in the annual information form of the Company dated June 23, 2021 and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedar.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.