Company: SXTPW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003343
Chunk: 17

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 17
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ropa.eu/en/dengue-monthly#:~:text=This%20is%20an%20increase%20of%2032%20653%20cases% 20and%2032,853%20deaths%20have%20been%20reported.

    20
    https://www.cdc.gov/rsv/php/surveillance/index.html#cdc_survey_profile_surveys_used-rsv-burden-estimates.

7

More
information about our products is provided in the next section, and the status of various development efforts for the above-mentioned
diseases is outlined in Figure A, below.

Figure
A

Products

Arakoda
(Tafenoquine) for malaria prevention

We
entered into a cooperative research and development agreement with the United States Army in 2014 to complete development of Arakoda
for prevention of malaria.21 With the U.S. Army, and other private sector entities as partners, we coordinated the execution
of two clinical trials, development of a full manufacturing package, gap-filling non-clinical studies, compilation of a full regulatory
dossier, successful defense of our program at an FDA advisory committee meeting and submitted a new drug application (“NDA”)
to the FDA in 2018. The history of that collaboration has been publicly communicated by the U.S. Army.22

    21
    In 2014, we signed a cooperative
    research and development agreement with the United States Army Medical and Materiel Development Activity (Agreement W81XWH-14-0313).
    Under this agreement, we agreed to submit an NDA for Tafenoquine to the FDA (as Arakoda), while the US Army agreed to finance the
    bulk of the necessary development activities in support of that goal.
  
    22
    Zottig et al Military Medicine
    2020; 185 (S1): 687.

8

The
FDA and Australia’s medicinal regulatory agency, the Therapeutic Goods Administration, subsequently approved Arakoda (brand name
in the U.S.) and Kodatef (brand name in Australia), respectively, for prevention of malaria in travelers in 2018. Prescribing information
and guidance for patients can be found at www.arakoda.com. The features and benefits of Tafenoquine for malaria prophylaxis, some
of which have been noted by third-party experts, include: convenient once weekly dosing following a three