60 Degrees Pharmaceuticals Awarded Contract with U.S. Army for ARAKODA® Supply Chain Upgrade Support
60 Degrees Pharmaceuticals (NASDAQ: SXTP) has been awarded a contract with the U.S. Army Medical Materiel Development Activity to support commercial validation of new packaging for ARAKODA® (tafenoquine), its FDA-approved malaria prevention product. This follows the company's increase in ARAKODA's commercial batch size in Q1 2024, anticipating higher sales volume. Notably, Q1 2024 ARAKODA sales revenue surged 515% year-over-year to $105.7 thousand.
The company aims to ensure a sustainable supply of ARAKODA for civilian and military customers in the U.S. Additionally, 60 Degrees Pharmaceuticals is exploring ARAKODA's potential role in treating babesiosis, an emerging tick-borne disease that can be life-threatening in elderly and immunosuppressed patients.
60 Degrees Pharmaceuticals (NASDAQ: SXTP) ha ricevuto un contratto con l'U.S. Army Medical Materiel Development Activity per supportare la validazione commerciale di nuovi imballaggi per ARAKODA® (tafenoquina), il suo prodotto approvato dalla FDA per la prevenzione della malaria. Questo arriva dopo l'aumento della dimensione del lotto commerciale di ARAKODA nel primo trimestre del 2024, anticipando un volume di vendite più elevato. Vale la pena notare che le entrate delle vendite di ARAKODA nel Q1 2024 sono aumentate del 515% rispetto all'anno precedente, raggiungendo i 105,7 mila dollari.
L'azienda mira a garantire una fornitura sostenibile di ARAKODA per clienti civili e militari negli Stati Uniti. Inoltre, 60 Degrees Pharmaceuticals sta esplorando il potenziale ruolo di ARAKODA nel trattamento della babesiosi, una malattia emergente trasmessa dalle zecche che può essere pericolosa per la vita negli anziani e nei pazienti immunocompromessi.
60 Degrees Pharmaceuticals (NASDAQ: SXTP) ha sido galardonada con un contrato de la U.S. Army Medical Materiel Development Activity para apoyar la validación comercial de nuevos envases para ARAKODA® (tafenoquina), su producto aprobado por la FDA para la prevención de la malaria. Esto sigue al aumento del tamaño de lote comercial de ARAKODA en el primer trimestre de 2024, anticipando un mayor volumen de ventas. Notablemente, los ingresos por ventas de ARAKODA en el Q1 2024 aumentaron un 515% interanual, alcanzando los 105,7 mil dólares.
La compañía tiene como objetivo garantizar un suministro sostenible de ARAKODA para clientes civiles y militares en EE. UU. Además, 60 Degrees Pharmaceuticals está explorando el potencial de ARAKODA en el tratamiento de la babesiosis, una enfermedad emergente transmitida por garrapatas que puede amenazar la vida en ancianos y pacientes inmunocomprometidos.
60 Degrees Pharmaceuticals (NASDAQ: SXTP)는 미국 육군 의료 물자 개발 활동과 계약을 체결하여 ARAKODA® (타페노퀸)의 새로운 포장에 대한 상업적 검증을 지원합니다. 이는 2024년 1분기에 ARAKODA의 상업적 배치 크기를 증가시킨 후이며, 판매량 증가를 예상하고 있습니다. 특히, 2024년 1분기 ARAKODA 매출이 전년 대비 515% 증가하여 105,700달러에 달했습니다.
회사는 미국의 민간 및 군사 고객에게 ARAKODA의 지속 가능한 공급을 보장하는 것을 목표로 하고 있습니다. 또한, 60 Degrees Pharmaceuticals는 ARAKODA가 노인 및 면역 억제 환자에게 생명 위협이 될 수 있는 신종 진드기 매개 질병인 바베시증 치료에 기여할 수 있는 잠재력을 탐색하고 있습니다.
60 Degrees Pharmaceuticals (NASDAQ: SXTP) a reçu un contrat de la U.S. Army Medical Materiel Development Activity pour soutenir la validation commerciale de nouveaux emballages pour ARAKODA® (tafénoquine), son produit approuvé par la FDA pour la prévention de la malaria. Cela fait suite à l'augmentation de la taille des lots commerciaux d'ARAKODA au premier trimestre de 2024, en anticipant un plus grand volume de ventes. Il est à noter que les revenus des ventes d'ARAKODA au premier trimestre 2024 ont augmenté de 515% par rapport à l'année précédente, atteignant 105,7 mille dollars.
L'entreprise vise à garantir un approvisionnement durable d'ARAKODA pour les clients civils et militaires aux États-Unis. De plus, 60 Degrees Pharmaceuticals explore le rôle potentiel d'ARAKODA dans le traitement de la babesiose, une maladie émergente transmise par les tiques qui peut être mortelle chez les personnes âgées et les patients immunodéprimés.
60 Degrees Pharmaceuticals (NASDAQ: SXTP) hat einen Vertrag mit der U.S. Army Medical Materiel Development Activity erhalten, um die kommerzielle Validierung neuer Verpackungen für ARAKODA® (Tafenoquin), sein von der FDA genehmigtes Malariaprophylaxe-Produkt, zu unterstützen. Dies folgt auf die Erhöhung der kommerziellen Batch-Größe von ARAKODA im ersten Quartal 2024, da ein höheres Verkaufsvolumen erwartet wird. Bemerkenswert ist, dass die ARAKODA-Umsätze im Q1 2024 im Vergleich zum Vorjahr um 515% auf 105,7 Tausend Dollar gestiegen sind.
Das Unternehmen zielt darauf ab, eine nachhaltige Versorgung mit ARAKODA für zivile und militärische Kunden in den USA sicherzustellen. Darüber hinaus untersucht 60 Degrees Pharmaceuticals das potenzielle Einsatzgebiet von ARAKODA bei der Behandlung von Babesiose, einer aufkommenden durch Zecken übertragenen Krankheit, die bei älteren und immungeschwächten Patienten lebensbedrohlich sein kann.
- Contract awarded with U.S. Army for ARAKODA supply chain upgrade support
- Q1 2024 ARAKODA sales revenue increased 515% year-over-year to $105.7 thousand
- Increased commercial batch size of ARAKODA in Q1 2024 anticipating higher sales volume
- Potential expansion of ARAKODA use for treatment of babesiosis
- None.
The contract awarded to 60 Degrees Pharmaceuticals by the U.S. Army for ARAKODA® supply chain upgrades is a positive development for the company. This support demonstrates military interest in the product and could potentially lead to increased sales and market penetration. The
The company's proactive approach in increasing commercial batch sizes in anticipation of higher sales volume shows strategic planning. However, investors should be cautious as the revenue base is still small and significant growth will be needed to justify the company's valuation. The potential expansion into babesiosis treatment, while promising, is still speculative and not yet FDA-approved.
From a financial perspective, the military contract and sales growth are encouraging signs, but the company's path to profitability and sustainable revenue growth remains uncertain. Investors should closely monitor future quarters to see if the sales momentum continues and whether the supply chain upgrades translate into improved margins and scalability.
The contract with the U.S. Army for ARAKODA® supply chain upgrades is significant from a medical research perspective. It suggests confidence in the product's efficacy and potential for wider use. The increased batch size and packaging improvements could facilitate larger clinical trials and easier distribution, which is important for a medication targeting travelers and military personnel.
The potential application of tafenoquine for babesiosis treatment is intriguing. Babesiosis, an emerging tick-borne disease, lacks effective treatments, especially for severe cases. If ARAKODA proves effective against babesiosis, it could significantly expand the drug's market potential and medical importance. However, it's important to note that this is still hypothetical and requires rigorous clinical trials and FDA approval.
The
- 60 Degrees Pharmaceuticals has been awarded a contract with the United States Army Medical Materiel Development Activity to facilitate commercial validation of new bottle and replacement blister packaging of ARAKODA® (tafenoquine), the Company’s FDA-approved product indicated for malaria prevention
- Anticipating increasing ARAKODA sales volume in 2024, the Company increased the commercial batch size of ARAKODA in Q1 2024
- Q1 2024 ARAKODA sales revenue increased
515% year-over-year to$105.7 thousand
WASHINGTON, July 25, 2024 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, announced today that it has been awarded a fixed-price contract with the United States Army Medical Materiel Development Activity to support commercial validation of new bottle and replacement blister packaging of ARAKODA® (tafenoquine), the Company’s malaria prevention product.
This follows the implementation of an increased tablet compression batch size in Q1 2024, planned in anticipation of increasing sales volume in 2024. Recently, 60 Degrees Pharmaceuticals announced that Q1 2024 ARAKODA net sales revenues increased
“Supply chain upgrade support from the United States Army Medical Materiel Development Activity is most welcome and important to our primary commercial goal of ensuring a sustainable supply of ARAKODA for our civilian and military customers in the U.S.,” said Chief Executive Officer of 60 Degrees Pharmaceuticals, Geoff Dow. “We are very proud of our uninterrupted supply of ARAKODA to the U.S. market, even in light of the earlier impact of the pandemic on international travel. We anticipate that, increasingly and over time, the U.S. healthcare provider community will recognize the advantages of using ARAKODA for malaria prevention. Also, the potential life-saving role the product may play in the treatment of all forms of babesiosis in the future is certainly very exciting.”
Babesiosis is a steadily emerging, tick-borne disease transmitted through the bite of the black-legged (deer) tick, the vector that spreads Lyme disease. An orphan disease, babesiosis may be life-threatening in elderly and immunosuppressed patients.
ARAKODA is indicated for the prophylaxis of malaria in patients aged 18 years and older. 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 with funding from 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.
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. The statements expressed herein are those of 60 Degrees Pharmaceuticals, Inc. and do not necessarily represent those of the U.S. Department of Defense.
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; 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 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. Burke
SheilaBurke-consultant@60degreespharma.com
(484) 667-6330
Investor Contact:
Patrick Gaynes
patrickgaynes@60degreespharma.com
(310) 989-5666
FAQ
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