Sixty Degrees Pharmaceuticals and Tufts Medical Center Announce Patent License Agreement to Advance Development of Tafenoquine for Babesiosis Treatment and Prevention
60 Degrees Pharmaceuticals (NASDAQ: SXTP) and Tufts Medical Center have signed a Patent License Agreement to develop and commercialize tafenoquine for babesiosis treatment and prevention. The agreement establishes joint patent ownership, with 60 Degrees leading global commercialization efforts and holding exclusive rights. Tufts MC will receive royalties on net sales while retaining research rights. The collaboration aims to address an unmet medical need, as tafenoquine could potentially become the first prophylaxis available for babesiosis, a tick-borne disease affecting red blood cells. The agreement follows initial research collaboration between both organizations, resulting in U.S. Provisional Patent Application No. 63/461,060.
60 Degrees Pharmaceuticals (NASDAQ: SXTP) e Tufts Medical Center hanno firmato un Accordo di Licenza per Brevetti per sviluppare e commercializzare tafenoquine per il trattamento e la prevenzione della babesiosi. L'accordo stabilisce una proprietà congiunta del brevetto, con 60 Degrees che guida gli sforzi di commercializzazione globale e detiene i diritti esclusivi. Tufts MC riceverà royalties sulle vendite nette mantenendo i diritti di ricerca. La collaborazione mira a soddisfare un'esigenza medica non soddisfatta, poiché la tafenoquina potrebbe diventare la prima profilassi disponibile per la babesiosi, una malattia trasmessa dalle zecche che colpisce i globuli rossi. L'accordo segue una collaborazione di ricerca iniziale tra le due organizzazioni, risultante nella domanda di brevetto provvisoria statunitense n. 63/461,060.
60 Degrees Pharmaceuticals (NASDAQ: SXTP) y Tufts Medical Center han firmado un Acuerdo de Licencia de Patente para desarrollar y comercializar tafenoquina para el tratamiento y prevención de la babesiosis. El acuerdo establece la propiedad conjunta de la patente, con 60 Degrees liderando los esfuerzos de comercialización global y manteniendo los derechos exclusivos. Tufts MC recibirá regalías sobre las ventas netas mientras retiene los derechos de investigación. La colaboración tiene como objetivo abordar una necesidad médica no satisfecha, ya que la tafenoquina podría convertirse en la primera profilaxis disponible para la babesiosis, una enfermedad transmitida por garrapatas que afecta a los glóbulos rojos. El acuerdo sigue a una colaboración de investigación inicial entre ambas organizaciones, resultando en la Solicitud de Patente Provisional de EE. UU. No. 63/461,060.
60 Degrees Pharmaceuticals (NASDAQ: SXTP)와 Tufts Medical Center는 tafenoquine을 babesiosis 치료 및 예방을 위해 개발 및 상용화하는 특허 라이선스 계약을 체결했습니다. 이 계약은 공동 특허 소유권을 설정하며, 60 Degrees가 글로벌 상용화 노력을 주도하고 독점권을 보유합니다. Tufts MC는 순매출에 대한 로열티를 받을 것이며 연구 권리를 유지합니다. 이 협력은 unmet medical need를 해결하는 것을 목표로 하며, tafenoquine은 적혈구에 영향을 미치는 진드기 매개 질병인 babesiosis의 첫 번째 예방 수단이 될 가능성이 있습니다. 이 계약은 두 기관 간의 초기 연구 협력의 결과로, 미국 잠정 특허 출원 번호 63/461,060이 포함됩니다.
60 Degrees Pharmaceuticals (NASDAQ: SXTP) et Tufts Medical Center ont signé un Accord de Licence de Brevet pour développer et commercialiser tafénocline pour le traitement et la prévention de la babesiose. L'accord établit une propriété conjointe du brevet, avec 60 Degrees qui dirige les efforts de commercialisation mondiale et détient les droits exclusifs. Tufts MC recevra des redevances sur les ventes nettes tout en conservant les droits de recherche. Cette collaboration vise à répondre à un besoin médical non satisfait, car la tafénocline pourrait potentiellement devenir la première prophylaxie disponible pour la babesiose, une maladie transmise par les tiques qui affecte les globules rouges. L'accord fait suite à une collaboration de recherche initiale entre les deux organisations, aboutissant à la demande de brevet provisoire américaine n° 63/461,060.
60 Degrees Pharmaceuticals (NASDAQ: SXTP) und Tufts Medical Center haben eine Patentlizenzvereinbarung unterzeichnet, um tafenoquine zur Behandlung und Prävention von Babesiose zu entwickeln und zu vermarkten. Die Vereinbarung legt ein gemeinsames Patentrecht fest, wobei 60 Degrees die globalen Vermarktungsanstrengungen leitet und exklusive Rechte hält. Tufts MC erhält Lizenzgebühren auf den Nettoumsatz und behält die Forschungsrechte. Die Zusammenarbeit zielt darauf ab, einen nicht erfüllten medizinischen Bedarf zu decken, da Tafenoquin möglicherweise das erste verfügbare Prophylaktikum gegen Babesiose werden könnte, eine von Zecken übertragene Krankheit, die die roten Blutkörperchen betrifft. Die Vereinbarung folgt einer ersten Forschungskooperation zwischen beiden Organisationen, die zur US-Provisional-Patentanmeldung Nr. 63/461,060 geführt hat.
- Exclusive global commercialization rights secured for tafenoquine in babesiosis
- Potential first-mover advantage in babesiosis prophylaxis market
- Joint patent ownership strengthens intellectual property position
- Tafenoquine not yet FDA-approved for babesiosis treatment
- Future royalty payments to Tufts MC will impact profit margins
- Significant development and regulatory hurdles ahead before commercialization
Insights
This patent licensing agreement marks a strategic advancement in addressing an underserved market for babesiosis treatment. Tafenoquine, already known for malaria prevention, could potentially create a new revenue stream through this indication expansion. The deal structure is particularly favorable, with 60 Degrees securing exclusive global commercialization rights while sharing IP ownership.
The most compelling aspect is the potential first-mover advantage in babesiosis prophylaxis - an entirely untapped market. For a small-cap company (
The development pathway likely benefits from tafenoquine's existing safety profile from its malaria indication (ARAKODA), potentially streamlining the regulatory process. However, investors should note that FDA approval remains a significant hurdle and the timeline to commercialization could be extensive.
The therapeutic potential of tafenoquine for babesiosis is scientifically compelling. Babesiosis, like malaria, involves parasitic infection of red blood cells, suggesting a mechanistic rationale for tafenoquine's application. Current treatment options are , particularly for severe cases, making this development significant from a clinical perspective.
The prophylactic potential is particularly noteworthy given the increasing prevalence of tick-borne diseases in endemic regions. Having a preventive option could dramatically impact disease management strategies, especially for high-risk populations in endemic areas. The collaboration with Tufts MC, a respected academic medical center, adds credibility to the research foundation.
WASHINGTON, Dec. 23, 2024 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees” or the “Company”), pharmaceutical company, and Tufts Medical Center (“Tufts MC”), a leading academic medical center, today announced the signing of a Patent License Agreement to jointly advance the development and commercialization of tafenoquine for the treatment and prevention of babesiosis.
Tafenoquine is not currently approved by the U.S. Food and Drug Administration (“FDA”) for the treatment and prevention of babesiosis.
The agreement follows initiation of collaboration between researchers from both organizations to study the activity of tafenoquine against babesiosis, a serious tick-borne disease caused by microscopic parasites that infect red blood cells. The study formed the basis of U.S. Provisional Patent Application No. 63/461,060, and related U.S. utility and PCT applications, granting the parties shared intellectual property rights to tafenoquine’s potential future use for babesiosis.
Key Highlights of the Agreement:
- Joint Patent Ownership: 60 Degrees and Tufts MC will co-own patent applications related to tafenoquine for babesiosis, with the Company leading prosecution and maintenance activities worldwide.
- Commercialization Rights: 60 Degrees holds exclusive global rights to commercialize tafenoquine for babesiosis, including sublicensing to third parties for product development and sales.
- Research Collaboration: Tufts MC retains a royalty-free, global license for research purposes, further advancing innovation in this area.
- Royalties and Revenue Sharing: Tufts MC will receive royalties on net sales of tafenoquine-based products labeled for babesiosis treatment or prevention.
- Commitment to Development: 60 Degrees has committed to using commercially reasonable efforts to bring tafenoquine products to market (beyond ARAKODA) and to expanding access to innovative therapies for babesiosis.
“This agreement demonstrates the growing confidence Tufts Medical Center and 60 Degrees Pharmaceuticals have in tafenoquine’s potential as a next-generation therapeutic for babesiosis,” said Chief Executive Officer of 60 Degrees Pharmaceuticals, Inc., Geoff Dow, PhD. “Today, those whose disease has progressed past the initial stages of mild symptoms may have limited treatment options. We believe tafenoquine, if approved, has the potential to meet this growing unmet need. Tafenoquine also has the potential to become the first prophylaxis available for babesiosis.”
About Babesiosis and the Study of Tafenoquine for Patients Hospitalized with Babesiosis
Babesiosis is a steadily emerging, infectious disease that is caused by a microscopic parasite, Babesia, and is transmitted through the bite of the black-legged (deer) tick, the vector that also spreads Lyme disease. Babesiosis, an orphan disease, may be life-threatening in elderly and immunosuppressed patients. Up to 10 percent of Lyme disease patients may be coinfected with Babesia. Therefore, up to 47,600 of the estimated 476,000 patients with new Lyme infections each year may be coinfected with Babesia. Cases reported in the medical literature suggest that tafenoquine is a promising therapeutic for patients with relapsing babesiosis. The efficacy and safety of 8-aminoquinolines, a class of drugs that includes tafenoquine and primaquine, are well documented.
60 Degrees Pharmaceuticals is the sponsor of a clinical trial evaluating the efficacy and safety of tafenoquine in treating severe babesiosis in humans. The trial is now enrolling and is being conducted at multiple sites in the U.S., including at Tufts Medical Center, Rhode Island Hospital, Yale University and Brigham and Women’s Hospital. The study is a randomized, double-blind, placebo-controlled trial that compares the safety and efficacy of tafenoquine versus placebo in patients hospitalized for babesiosis and treated with standard-of-care. The two main study endpoints will be the time to sustained clinical resolution of symptoms and the time to molecular cure as determined by an FDA-approved nucleic acid test. At least 24, and as many as 33 patients, will be recruited before an interim analysis is conducted. The interim analysis will include both a test of significance, as well as size re-estimation to allow additional recruitment if required.
Tafenoquine is approved for malaria prophylaxis 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 U.S. Food and Drug Administration for such an indication.
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.
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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
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FAQ
What are the key terms of SXTP's patent license agreement with Tufts Medical Center?
What is the current FDA approval status of SXTP's tafenoquine for babesiosis?
What market opportunity is SXTP targeting with tafenoquine for babesiosis?
How will the Tufts Medical Center partnership affect SXTP's revenue structure?
