60 Degrees Pharmaceuticals announces FDA approval to import KODATEF® as a precautionary measure amidst increasing ARAKODA® demand.
Quiver AI Summary
60 Degrees Pharmaceuticals, Inc. announced that the FDA has approved its plan to import KODATEF® (tafenoquine) from Australia as a precautionary measure to prevent potential supply disruptions of its U.S. product, ARAKODA® (tafenoquine), which is used for malaria prophylaxis in adults. Both products are identical in formulation and dosage and have seen increased demand in the U.S. market. The import will consist of a five-month supply of KODATEF while the company increases its ARAKODA manufacturing capacity. The proactive step reflects 60 Degrees' commitment to ensuring the availability of malaria prevention medication. A notice of this decision will be posted on the FDA's website.
Potential Positives
- 60 Degrees Pharmaceuticals has received FDA clearance to import KODATEF® as a proactive measure to prevent potential supply disruptions of ARAKODA®, ensuring continued availability of this essential medication for malaria prophylaxis.
- The import plan demonstrates the company's commitment to maintaining a reliable supply of tafenoquine, responding to increasing demand for ARAKODA in the U.S.
- The company's initiative to import a five-month supply of KODATEF may strengthen its position in the market and enhance relationships with healthcare providers by ensuring patient access to treatment.
- 60 Degrees Pharmaceuticals is actively increasing manufacturing output of ARAKODA, which could lead to better supply chain stability and potentially greater revenue growth in the future.
Potential Negatives
- The FDA's approval of importing KODATEF as a contingency measure may suggest a potential instability in the supply chain for ARAKODA, raising concerns about the company's ability to meet increasing demand.
- KODATEF is not approved for use in the U.S., which may complicate the company's operations and could impact its market credibility.
- The press release includes a caution about forward-looking statements, indicating significant uncertainties about the company's future performance and ongoing viability, including doubts about going concern status and manufacturing capacity.
FAQ
What is the significance of 60 Degrees Pharmaceuticals importing KODATEF?
The import of KODATEF ensures continued availability of tafenoquine for malaria prophylaxis amidst growing demand for ARAKODA in the U.S.
What are ARAKODA and KODATEF used for?
Both ARAKODA and KODATEF are indicated for the prophylaxis of malaria in adults aged 18 and older.
How does the FDA respond to the import of KODATEF?
The FDA has expressed no objections to 60 Degrees' plan to import KODATEF to address supply concerns for ARAKODA.
What are the dosing regimens for ARAKODA?
ARAKODA is taken as a loading dose of 2 x 100 mg tablets daily for three days, then weekly during travel.
What precautions must be taken when using ARAKODA?
ARAKODA should not be used in patients with G6PD deficiency, psychotic disorders, or hypersensitivity reactions to tafenoquine.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
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
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