Appili Therapeutics Expands ATI-1501 Commercial Agreement with Partner Saptalis Pharmaceuticals
08 Février 2022 - 01:17PM
Business Wire
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20220208005344/en/
Media Contact: Danielle Raabe/APCO Worldwide T:
1-646-717-9915 E: DRaabe@apcoworldwide.com
Investor Relations Contact: Stéphane Paquette; Vice
President, Corporate Development Appili Therapeutics E:
Info@AppiliTherapeutics.com
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