Babesiosis

WASHINGTON, March 14, 2024 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc., (NASDAQ: SXTP, SXTPW) (“60 Degrees Pharmaceuticals” or the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has communicated its intention to send any comments regarding the Company’s babesiosis trial within the month of April, 2024, rather than March, 2024 as anticipated by the Company. The protocol submission mechanism as directed by the FDA, i.e., under the Company’s existing (rather than a new) Investigational New Drug application, technically does not require a response from the FDA within a specified time frame. The Company is continuing preparations for a June 1, 2024 start date as previously communicated. Tafenoquine is the active ingredient in an anti-malarial approved by the FDA in 2018 and is indicated for the prophylaxis of malaria in patients aged 18 years of age and older. 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, may offer potential advantages in less frequent dosing for prophylaxis for malaria. ARAKODA® is not suitable for everyone, and patients and prescribers should review the Important Safety Information below. ARAKODA® (tafenoquine) Important Safety Information ARAKODA® is an antimalarial indicated for the prophylaxis of malaria in patients aged 18 years of age and older. Contraindications ARAKODA® should not be administered to: Patients with Glucose-6-phosphate dehydrogenase (G6PD) deficiency or unknown G6PD status. Lactating women who are breastfeeding 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. Patients with 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%) were: headache, dizziness, back pain, diarrhea, nausea, vomiting, increased alanine aminotransferase, 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 at 1- 888-834-0225 or FDA at 1-800-FDA-1088 or . ARAKODA® full prescribing information is 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 achieved FDA approval of its lead product, ARAKODA® (tafenoquine) for malaria prevention, in 2018. 60 Degrees Pharmaceuticals also collaborates with prominent research organizations in the U.S., Australia and Singapore. The 60 Degrees Pharmaceuticals mission has been supported through in-kind funding from the United States Department of Defense and private institutional investors including Knight Therapeutics Inc., a Canadian-based pan-American specialty pharmaceutical company. 60 Degrees Pharmaceuticals is headquartered in Washington D.C., with a majority-owned subsidiary in Australia. Learn more at . 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 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; 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 our Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at 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 Contacts: Sheila A. Burke SheilaBurke-consultant@60degreespharma.com (484) 667-6330 Investor Contact: Patrick Gaynes patrickgaynes@60degreespharma.com (310) 989-5666

BATON ROUGE, La., Feb. 22, 2024 /PRNewswire/ -- With the annual vector season coming up, University Products recently underscored the critical importance of early vaccination against bovine anaplasmosis to reduce herd losses. Offering a sensible and budget-friendly solution for cattle farmers nationwide, the University Products Anaplasmosis Vaccine has been field-tested for over 20 years and provides superior protection against this devastating endemic disease. Continue Reading University Products LLC University Products LLC "Anaplasmosis remains a longstanding challenge for the cattle industry," said Gene Luther, Director of University Products. "It significantly impacts the health and productivity of herds every single year and it hits hard in the spring, summer and fall especially, when insects like ticks and biting flies begin to flourish, spreading disease. So you don't want to wait until your herd is already infected before you start thinking about preventive measures. Start now. Especially since the FDA has imposed stricter rules for antibiotic use." University Products' vaccine stands out for its affordability, with per-dose costs nearly half that of diagnostic lab testing, and also for its effectiveness in reducing clinical symptoms associated with anaplasmosis. Getting Ahead of Vector Season: Navigating Regulatory Changes The importance of timely and effective disease management strategies is highlighted by recent draft guidance from the Food and Drug Administration concerning antimicrobial drugs given to food -producing animals. Those drugs, previously much easier to get, now require veterinarian approval and administration. The National Cattlemen's Beef Association (NCBA) also weighed in on the potential challenges of implementing new FDA guidelines, which now also require duration labeling for products treating anaplasmosis. NCBA Chief Veterinarian Dr. Kathy Simmons warned that such labeling was problematic at best, stating: "Some of these diseases that are vector borne see variations in the vector season based on the climate that you're raising cattle. They may not be able to give a specific duration. They may have to publish a maximum duration and that won't be easy either." Of this specific concern, Gene Luther from University Products said, "This just underscores the many challenges our industry faces when dealing with bovine disease. But fortunately, our vaccine is already a straightforward, reliable solution. Our vaccine can be used in any climate, during any season." Some General Spring Calving Vector Recommendations: Vaccinate herds for anaplasmosis, if not previously done. Continue other vector measures for the herd like fly and tick control programs. Check spraying equipment, dust bags, and oilers, and obtain needed chemicals or tags for fly and tick control. Consider professional controlled-burns and/or chemical sprays to keep excessive weeds and brush in check. Always contact professionals for these mitigation measures. The Bottom Line: Economic Benefits of Vaccines "Our vaccine's affordability enables more small and mid-sized cattle farmers to protect their herds too," said Gene Luther. "While minimizing financial strain. That's who we try to reach first – who we try to help the most: farmers who do not have enormous corporate budgets to work with. These folks need help that is immediate and cost effective." The University Products vaccine does not prevent infection, but when properly used, significantly reduces clinical signs in at-risk animals. The vaccine requires only two doses in the first year, with one annual booster each year thereafter, and is safe to use in any stage of bovine pregnancy. A detailed description of the vaccine and its method of administration is publicly available for PDF download. For more information on vaccine availability for ranchers and veterinarians, please contact University Products directly. About University Products LLC Based in Louisiana, University Products specializes in USDA approved (for experimental use) bovine vaccines. Their anaplasmosis vaccine minimizes clinical signs in at-risk animals, is safe during pregnancy, and requires two initial doses plus annual boosters. The company is also researching vaccines for bovine babesiosis and theileriosis. Veterinarians can inquire about availability by emailing directly at [email protected]. Certain facts, quotes, and guidelines sourced from: Oklahoma State University: Media Contact: Gene Luther, Director 1-225-334-0851 [email protected] SOURCE University Products LLC

To lead U.S. commercial relaunch of ARAKODA® (tafenoquine) for malaria preventionWill support Company plan to expand clinical research strategy in tick-borne diseases beyond acute babesiosis WASHINGTON, Feb. 08, 2024 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60P” or the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, announced today it has appointed Kristen Landon to the newly created role of Chief Commercial Officer, effective immediately. Ms. Landon is an accomplished commercial leader with over 26 years’ experience launching, building, and transforming commercial teams and brands in the pharmaceutical industry. “We screened hundreds of applicants during the second half of 2023 and Kristen’s vision and directly relevant experience made her the ideal match for the position,” said Geoff Dow, PhD., 60 Degrees Pharma Chief Executive Officer. “With this hire and last month’s financing, management and the Board are excited about the milestones we aim to achieve in the coming quarters.” “I am impressed by the vision and track record that the 60 Degrees team has demonstrated by the achievement of FDA approval for ARAKODA, a successful IPO and recent FDA support of a clinical babesiosis program,” said Ms. Landon. “We have had extensive discussions about our commercial path and I’m confident in this team’s ability to grow the business based on smart planning and focused execution.” Most recently, Ms Landon served as Senior Vice President of Marketing and Communications at TherapeuticsMD. Previous commercial leadership roles include Vice President of Marketing at Radius Health, Vice President of Marketing at Sprout, and Executive Director of Women’s Health Global Brands at Actavis. Earlier in her career, Ms. Landon held roles of increasing responsibility in sales and marketing leadership at Abbott Labs and Novartis. Ms. Landon holds an MBA from Silberman College of Business at Fairleigh Dickinson University, and a Bachelor’s degree from Kean University. Tafenoquine is approved for malaria prophylaxis in patients aged 18 years and older in the United States under the product name ARAKODA®. The safety of the approved regimen of tafenoquine for malaria prophylaxis has been assessed in five separate randomized, double-blind, active comparator or placebo-controlled trials for durations of up to six months. Tafenoquine has not been proven to be effective for treatment or prevention of babesiosis and is not approved by the FDA for such an indication. About ARAKODA® (tafenoquine) Tafenoquine was discovered by Walter Reed Army Institute of Research and the current study was funded by the United States Army Medical & Materiel Development Activity. 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. 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 of age 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; orKnown 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 17 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 (OCT2) or multidrug and toxin extrusion (MATE) 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 achieved FDA approval of its lead product, ARAKODA® (tafenoquine), for malaria prevention in 2018. 60 Degrees Pharmaceuticals also collaborates with prominent research organizations in the U.S., Australia and Singapore. The 60 Degrees Pharmaceutical mission has been supported through in-kind funding from the DOD and private institutional investors including Knight Therapeutics Inc., a Canadian-based pan-American specialty pharmaceutical company. 60 Degrees Pharmaceuticals is headquartered in Washington D.C., with a majority-owned subsidiary in Australia. Learn more at www.60degreespharma.com. Disclaimer & Cautionary Note Regarding Forward-Looking Statements The statements made about our tafenoquine-babesiosis clinical trial in this press release are based on both written correspondence from the FDA ahead of the Company’s Type C meeting on January 17, 2024, and the Company’s minutes from the meeting. The Company has not received the FDA’s formal minutes from the meeting and will not do so until 30 days following January 17, 2024. Any information released by us about the protocol on clinicaltrials.gov, our website or elsewhere should be considered out of date as of the date of this press release. The Company has not yet rewritten its clinical protocol in light of FDA comments and there is no guarantee it will receive Institutional Review Board or FDA approval when resubmitted. The protocol will be resubmitted under our malaria Investigational New Drug Application, and is not subject to the minimum 30-day holding period required for a new Investigational New Drug Application. However, the FDA can at its discretion require changes to protocols at any time. 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 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; 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 the final prospectus to our Registration Statement on Form S-1 (File No.: 333-269483), as amended, initially filed with the SEC on January 31, 2023 relating to our initial public offering, and our subsequent Quarterly Report on Form 10-Q for the period ended June 30, 2023 and subsequent SEC filings. Investors and security holders are urged to read these documents free of charge on the SEC’s web site 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. BurkeSheilaBurke-consultant@60degreespharma.com(484) 667-6330 Investor Contact:Patrick Gaynespatrickgaynes@60degreespharma.com(310) 989-5666