Company: SXTPW
Filing Date: 2025-02-06
Form Type: 424B5
Source: 0001213900-25-010772
Chunk: 57

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-02-06
Form: 424B5
Chunk 57
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| 20 | https://www.ecdc.europa.eu/en/dengue-monthly#:~:text=This%20is%20an%20increase%20of%2032%20653%20cases% 
 20and%2032,853%20deaths%20have%20been%20reported.                                                       |

| 21 | https://www.cdc.gov/rsv/php/surveillance/index.html#cdc_survey_profile_surveys_used-rsv-burden-estimates.                            |
| 22 | 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.                                                                |

| 23 | Zottig et al Military Medicine 
 2020; 185 (S1): 687.           |

<div align='center'>4</div>

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 day load; the absence of reports of drug resistance during malaria prophylaxis; activity against liver and blood stages of malaria as well as both the major malaria species ( Plasmodium vivaxand Plasmodium falciparum); absence of any black-box safety warnings; good tolerability, including in women and individuals with prior psychiatric medical history; and a comparable adverse event rate to placebo with up to 12 months continuous dosing. 24Tafenoquine entered the commercial supply chains in the U.S. and Australia in the third quarter of 2019. The only limitation of Arakoda is the requirement for a G6PD test prior to administration. 25The G6PD test must be administered to a prospective patient prior to administration of Arakoda in order to prevent the potential occurrence of hemolytic an