Sixty Degrees Pharmaceuticals to Ensure Continuity of Tafenoquine Supply in U.S. by Importing Limited Quantity of KODATEF®
60 Degrees Pharmaceuticals (NASDAQ: SXTP) announced FDA's non-objection to import KODATEF® (tafenoquine) from Australia as a one-time measure to prevent potential supply disruptions of ARAKODA® in the U.S. market. Both medications are identical antimalarial drugs for adults 18 and older, with ARAKODA being the U.S. brand name and KODATEF being the Australian version.
The company plans to import a five-month supply of KODATEF while increasing ARAKODA manufacturing capacity, responding to growing product demand and awareness in the U.S. This proactive measure aims to ensure continuous availability of tafenoquine for malaria prophylaxis to healthcare providers.
60 Degrees Pharmaceuticals (NASDAQ: SXTP) ha annunciato che la FDA non si oppone all'importazione di KODATEF® (tafenoquine) dall'Australia come misura straordinaria per prevenire potenziali interruzioni della fornitura di ARAKODA® nel mercato statunitense. Entrambi i farmaci sono identici e sono usati come antimalarici per adulti di 18 anni e oltre, con ARAKODA che è il nome commerciale negli Stati Uniti e KODATEF che è la versione australiana.
La società prevede di importare una scorta di cinque mesi di KODATEF mentre aumenta la capacità di produzione di ARAKODA, rispondendo alla crescente domanda e consapevolezza del prodotto negli Stati Uniti. Questa misura proattiva ha lo scopo di garantire la continua disponibilità del tafenoquine per la profilassi della malaria ai fornitori di assistenza sanitaria.
60 Degrees Pharmaceuticals (NASDAQ: SXTP) anunció la no objeción de la FDA para importar KODATEF® (tafenoquina) desde Australia como una medida única para prevenir posibles interrupciones en el suministro de ARAKODA® en el mercado de EE. UU. Ambos medicamentos son idénticos y están indicados como antipalúdicos para adultos de 18 años o más, siendo ARAKODA el nombre de marca en EE. UU. y KODATEF la versión australiana.
La empresa planea importar un suministro para cinco meses de KODATEF mientras incrementa su capacidad de producción de ARAKODA, respondiendo a la creciente demanda y concienciación del producto en EE. UU. Esta medida proactiva tiene como objetivo asegurar la disponibilidad continua de tafenoquina para la profilaxis de la malaria para los proveedores de atención médica.
60 Degrees Pharmaceuticals (NASDAQ: SXTP)는 FDA가 호주에서 KODATEF® (타페노퀴닌)을 수입하는 데 이의를 제기하지 않았음을 발표했습니다. 이는 미국 시장에서 ARAKODA®의 잠재적 공급 중단을 방지하기 위한 일회성 조치입니다. 두 약물은 모두 18세 이상의 성인에게 사용되는 동일한 항말라리아 약물이지만, ARAKODA는 미국의 상표명이며 KODATEF는 호주 버전입니다.
회사는 KODATEF의 5개월 분량을 수입할 계획이며, 증가하는 ARAKODA 생산 능력에 대응하여 미국 내 제품 수요 및 인지도가 증가하고 있습니다. 이 선제적 조치는 말라리아 예방을 위한 타페노퀴닌의 지속적인 공급을 의료 제공자에게 보장하기 위한 목적입니다.
60 Degrees Pharmaceuticals (NASDAQ: SXTP) a annoncé que la FDA n’a pas d’objection à l’importation de KODATEF® (tafénoquine) d’Australie comme mesure unique pour prévenir d'éventuelles interruptions d'approvisionnement de ARAKODA® sur le marché américain. Les deux médicaments sont identiques et utilisés comme antipaludiques pour les adultes de 18 ans et plus, ARAKODA étant le nom de marque aux États-Unis et KODATEF étant la version australienne.
L'entreprise prévoit d'importer un approvisionnement de cinq mois de KODATEF tout en augmentant la capacité de production d'ARAKODA, en réponse à la demande croissante et à la sensibilisation au produit aux États-Unis. Cette mesure proactive vise à garantir la disponibilité continue de la tafénoquine pour la prophylaxie du paludisme auprès des prestataires de soins de santé.
60 Degrees Pharmaceuticals (NASDAQ: SXTP) gab bekannt, dass die FDA keine Einwände gegen die Einfuhr von KODATEF® (Tafenoquin) aus Australien erhebt, um potenzielle Versorgungsunterbrechungen von ARAKODA® auf dem US-Markt zu verhindern. Beide Medikamente sind identische Antimalariamittel für Erwachsene ab 18 Jahren, wobei ARAKODA der Markenname in den USA und KODATEF die australische Version ist.
Das Unternehmen plant, eine fünfmonatige Versorgung mit KODATEF zu importieren, während es die Produktionskapazität von ARAKODA erhöht, um auf die wachsende Produktnachfrage und das Bewusstsein in den USA zu reagieren. Diese proaktive Maßnahme zielt darauf ab, die kontinuierliche Verfügbarkeit von Tafenoquin für die Malariaprophylaxe für Gesundheitsdienstleister sicherzustellen.
- Growing demand and market awareness for ARAKODA in the U.S.
- FDA approval to import Australian version ensures product availability
- Proactive supply chain management to prevent potential disruptions
- Potential near-term supply chain constraints for ARAKODA in the U.S. market
- Need for temporary import solution indicates manufacturing capacity limitations
Insights
The FDA's non-objection to Sixty Degrees Pharmaceuticals' importation plan represents a significant strategic development that demonstrates both market opportunity and operational foresight. The growing demand for ARAKODA suggests expanding market penetration, while the proactive supply chain management indicates mature business planning.
From a business perspective, this development carries several key implications: First, the ability to import KODATEF provides an immediate solution to potential supply constraints, protecting market share and revenue streams. Second, the five-month import window creates a strategic buffer while the company scales up domestic manufacturing capacity, suggesting confidence in long-term market growth.
The identical clinical profiles between KODATEF and ARAKODA minimize regulatory risks and potential market resistance. This temporary solution allows the company to maintain market momentum without disrupting healthcare provider relationships or patient access. The FDA's support also signals regulatory confidence in the company's quality control and supply chain management capabilities.
While the short-term import strategy may impact margins due to additional logistics costs and potential currency exposure, it represents a calculated trade-off to protect market position and support growth. The decision to increase manufacturing output indicates management's commitment to long-term market expansion and operational efficiency.
WASHINGTON, Feb. 11, 2025 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees” or the “Company”), pharmaceutical company today announced that the United States Food and Drug Administration (FDA) does not object to the Company’s plan to import KODATEF® (tafenoquine) from Australia as a one-time, preemptive measure against any near-term disruption in the U.S. supply of ARAKODA® (tafenoquine).
ARAKODA is an antimalarial indicated for the prophylaxis of malaria in patients aged 18 years and older in the United States (U.S.) It is sold under the brand name KODATEF in Australia, where it is indicated for the prevention of malaria in adults 18 years of age and above. The two products are identical in their dosing regimens, mechanisms of action, safety and efficacy profiles, and other clinical features. KODATEF is not approved for use in the U.S.
Demand for ARAKODA has been steadily growing in recent months as awareness and use of the product has expanded across the U.S. The Company is taking the proactive step of importing KODATEF as a demonstration of its long-standing commitment to ensuring that tafenoquine for malaria prophylaxis remains readily available to healthcare providers at all times.
The Company plans to import a five-month supply of KODATEF while increasing manufacturing output of ARAKODA over the long-term.
A notice about this information is expected to be posted by FDA on its website.
About ARAKODA® (tafenoquine)
Tafenoquine was discovered by Walter Reed Army Institute of Research. Tafenoquine was approved for malaria prophylaxis in 2018 in the United States as ARAKODA® and in Australia as KODATEF®. Both were commercially launched in 2019 and are currently distributed through pharmaceutical wholesaler networks in each respective country. They are available at retail pharmacies as a prescription-only malaria prevention drug. According to the Centers for Disease Control and Prevention, the long terminal half-life of tafenoquine, which is approximately 16 days, offers the advantage of less frequent dosing for the prophylaxis of malaria. ARAKODA® is not suitable for everyone, and patients and prescribers should review the Important Safety Information below. Individuals at risk of contracting malaria are prescribed ARAKODA® 2 x 100 mg tablets once per day for three days (the loading phase) prior to travel to an area of the world where malaria is endemic, 2 x 100 mg tablets weekly for up to six months during travel, then 2 x 100 mg in the week following travel.
ARAKODA® (tafenoquine) Important Safety Information
ARAKODA® is an antimalarial indicated for the prophylaxis of malaria in patients aged 18 years and older.
Contraindications
ARAKODA® should not be administered to:
- Glucose-6-phosphate dehydrogenase (“G6PD”) deficiency or unknown G6PD status;
- Breastfeeding by a lactating woman when the infant is found to be G6PD deficient or if
- G6PD status is unknown;
- Patients with a history of psychotic disorders or current psychotic symptoms; or
- Known hypersensitivity reactions to tafenoquine, other 8-aminoquinolines, or any component of ARAKODA®.
Warnings and Precautions
Hemolytic Anemia: G6PD testing must be performed before prescribing ARAKODA® due to the risk of hemolytic anemia. Monitor patients for signs or symptoms of hemolysis.
G6PD Deficiency in Pregnancy or Lactation: ARAKODA® may cause fetal harm when administered to a pregnant woman with a G6PD-deficient fetus. ARAKODA® is not recommended during pregnancy. A G6PD-deficient infant may be at risk for hemolytic anemia from exposure to ARAKODA® through breast milk. Check infant’s G6PD status before breastfeeding begins.
Methemoglobinemia: Asymptomatic elevations in blood methemoglobin have been observed. Initiate appropriate therapy if signs or symptoms of methemoglobinemia occur.
Psychiatric Effects: Serious psychotic adverse reactions have been observed in patients with a history of psychosis or schizophrenia, at doses different from the approved dose. If psychotic symptoms (hallucinations, delusions, or grossly disorganized thinking or behavior) occur, consider discontinuation of ARAKODA® therapy and evaluation by a mental health professional as soon as possible.
Hypersensitivity Reactions: Serious hypersensitivity reactions have been observed with administration of ARAKODA®. If hypersensitivity reactions occur, institute appropriate therapy.
Delayed Adverse Reactions: Due to the long half-life of ARAKODA® (approximately 16 days), psychiatric effects, hemolytic anemia, methemoglobinemia, and hypersensitivity reactions may be delayed in onset and/or duration.
Adverse Reactions: The most common adverse reactions (incidence greater than or equal to 1 percent) were: headache, dizziness, back pain, diarrhea, nausea, vomiting, increased alanine aminotransferase (ALT), motion sickness, insomnia, depression, abnormal dreams, and anxiety.
Drug Interactions
Avoid co-administration with drugs that are substrates of organic cation transporter-2 or multidrug and toxin extrusion transporters.
Use in Specific Populations
Lactation: Advise women not to breastfeed a G6PD-deficient infant or infant with unknown G6PD status during treatment and for 3 months after the last dose of ARAKODA®.
To report SUSPECTED ADVERSE REACTIONS, contact 60 Degrees Pharmaceuticals, Inc. at 1- 888-834-0225 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The full prescribing information of ARAKODA® is located here.
About 60 Degrees Pharmaceuticals, Inc.
60 Degrees Pharmaceuticals, Inc., founded in 2010, specializes in developing and marketing new medicines for the treatment and prevention of infectious diseases that affect the lives of millions of people. 60 Degrees Pharmaceuticals, Inc. achieved FDA approval of its lead product, ARAKODA® (tafenoquine), for malaria prevention, in 2018. 60 Degrees Pharmaceuticals, Inc. also collaborates with prominent research organizations in the U.S., Australia, and Singapore. The 60 Degrees Pharmaceuticals, Inc. mission has been supported through in-kind funding from the U.S. Department of Defense and private institutional investors including Knight Therapeutics Inc., a Canadian-based pan-American specialty pharmaceutical company. 60 Degrees Pharmaceuticals, Inc. is headquartered in Washington D.C., with a majority-owned subsidiary in Australia. Learn more at www.60degreespharma.com. The statements contained herein may include prospects, statements of future expectations and other forward-looking statements that are based on management’s current views and assumptions and involve known and unknown risks and uncertainties. Actual results, performance or events may differ materially from those expressed or implied in such forward-looking statements.
Cautionary Note Regarding Forward-Looking Statements
This press release may contain “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward‐looking statements reflect the current view about future events. When used in this press release, the words “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan,” or the negative of these terms and similar expressions, as they relate to us or our management, identify forward‐looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy, activities of regulators and future regulations and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: there is substantial doubt as to our ability to continue on a going-concern basis; we might not be eligible for Australian government research and development tax rebates; if we are not able to successfully develop, obtain FDA approval for, and provide for the commercialization of non-malaria prevention indications for tafenoquine (ARAKODA® or other regimen) or Celgosivir in a timely manner, we may not be able to expand our business operations; we may not be able to successfully conduct planned clinical trials or patient recruitment in our trials might be slow or negligible; and we have no manufacturing capacity which puts us at risk of lengthy and costly delays of bringing our products to market. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (“SEC”), including the information contained in our Annual Report on Form 10-K filed with the SEC on April 1, 2024, and our subsequent SEC filings. Investors and security holders are urged to read these documents free of charge on the SEC’s website at www.sec.gov. As a result of these matters, changes in facts, assumptions not being realized or other circumstances, the Company’s actual results may differ materially from the expected results discussed in the forward-looking statements contained in this press release. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Media Contact:
Sheila A. Burke
SheilaBurke-consultant@60degreespharma.com
(484) 667-6330
Investor Contact:
Patrick Gaynes
patrickgaynes@60degreespharma.com
FAQ
What is the difference between KODATEF and ARAKODA (SXTP)?
Why is SXTP importing KODATEF from Australia in 2025?
How much KODATEF supply is SXTP planning to import?
Is KODATEF FDA-approved for use in the United States?
What is driving SXTP's decision to import KODATEF in 2025?
