TEPOXX (tecovirimat) Approved in Japan for the Treatment of Orthopoxviruses
SIGA Technologies announced that TEPOXX (tecovirimat) has received regulatory approval in Japan for treating orthopoxviruses, including smallpox, mpox, and cowpox, as well as complications from smallpox vaccination in adults and pediatric patients weighing at least 13 kg. This marks the first approval of an antiviral for orthopoxviruses in Japan.
SIGA has partnered with Japan Biotechno Pharma as its exclusive distributor and has already delivered TEPOXX to Japan's strategic national stockpile. The approval is based on data from 15 clinical trials involving over 800 healthy volunteers, including a pivotal study in Japan with 20 participants. The trials demonstrated no drug-related serious adverse events.
TEPOXX works by inhibiting the VP37 protein found on orthopoxviruses, preventing virus spread from infected cells. The drug is already approved in the U.S. and Canada for smallpox treatment, and in the EU and UK for smallpox, mpox, cowpox, and vaccination complications.
SIGA Technologies ha annunciato che TEPOXX (tecovirimat) ha ricevuto l'approvazione normativa in Giappone per il trattamento degli orthopoxvirus, inclusi il vaiolo, l'mpox e il vaiolo bovino, oltre alle complicazioni dalla vaccinazione contro il vaiolo in adulti e pazienti pediatrici che pesano almeno 13 kg. Questo segna la prima approvazione di un antivirale per gli orthopoxvirus in Giappone.
SIGA ha collaborato con Japan Biotechno Pharma come distributore esclusivo e ha già consegnato TEPOXX al magazzino nazionale strategico del Giappone. L'approvazione si basa su dati provenienti da 15 trial clinici che coinvolgono oltre 800 volontari sani, inclusa uno studio cruciale in Giappone con 20 partecipanti. I trial non hanno mostrato eventi avversi gravi correlati al farmaco.
TEPOXX agisce inibendo la proteina VP37 presente negli orthopoxvirus, impedendo la diffusione del virus dalle cellule infette. Il farmaco è già approvato negli Stati Uniti e in Canada per il trattamento del vaiolo, e nell'UE e nel Regno Unito per il vaiolo, l'mpox, il vaiolo bovino e le complicazioni dalla vaccinazione.
SIGA Technologies anunció que TEPOXX (tecovirimat) ha recibido aprobación regulatoria en Japón para tratar orthopoxvirus, incluyendo la viruela, mpox y viruela bovina, así como complicaciones de la vacunación contra la viruela en adultos y pacientes pediátricos que pesen al menos 13 kg. Esta es la primera aprobación de un antiviral para orthopoxvirus en Japón.
SIGA ha formado una asociación con Japan Biotechno Pharma como su distribuidor exclusivo y ya ha entregado TEPOXX a la reserva nacional estratégica de Japón. La aprobación se basa en datos de 15 ensayos clínicos que involucraron a más de 800 voluntarios sanos, incluyendo un estudio clave en Japón con 20 participantes. Los ensayos demostraron que no hubo eventos adversos graves relacionados con el medicamento.
TEPOXX actúa inhibiendo la proteína VP37 que se encuentra en los orthopoxvirus, evitando la propagación del virus desde células infectadas. El medicamento ya está aprobado en EE. UU. y Canadá para el tratamiento de la viruela, y en la UE y el Reino Unido para la viruela, mpox, viruela bovina y complicaciones de vacunación.
SIGA Technologies는 TEPOXX (tecovirimat)가 일본에서 천연두, mpox 및 소천두를 포함한 정형포바이러스 치료를 위한 규제 승인을 받았다고 발표했습니다. 이는 일본에서 정형포바이저스에 대한 항바이러스제가 최초로 승인된 사례입니다. 성인 및 최소 13kg의 체중을 가진 소아 환자의 천연두 예방접종에 따른 합병증 또한 포함됩니다.
SIGA는 Japan Biotechno Pharma와 독점 배급 계약을 체결하였으며, TEPOXX를 일본의 전략적 국가 비축에 이미 공급하였습니다. 이 승인은 15개의 임상 시험에서 얻은 데이터에 기반하며, 800명 이상의 건강한 자원자가 참여하였고, 그 중 일본에서의 주요 연구는 20명의 참가자를 포함합니다. 시험 결과 약물과 관련된 심각한 부작용은 없었습니다.
TEPOXX는 정형포바이러스에서 발견되는 VP37 단백질을 억제하여 감염된 세포에서 바이러스의 확산을 방지합니다. 이 약물은 이미 미국 및 캐나다에서 천연두 치료를 위해 승인되었으며, EU 및 영국에서는 천연두, mpox, 소천두 및 예방접종 합병증에 대해 승인되었습니다.
SIGA Technologies a annoncé que TEPOXX (tecovirimat) a reçu l'approbation réglementaire au Japon pour le traitement des orthopoxvirus, y compris la variole, l'mpox et la variole bovine, ainsi que des complications liées à la vaccination contre la variole chez les adultes et les patients pédiatriques pesant au moins 13 kg. Cela marque la première approbation d'un antiviral pour les orthopoxvirus au Japon.
SIGA a établi un partenariat avec Japan Biotechno Pharma en tant que distributeur exclusif et a déjà livré TEPOXX au stock stratégique national du Japon. L'approbation repose sur des données provenant de 15 essais cliniques impliquant plus de 800 volontaires en bonne santé, y compris une étude clé au Japon avec 20 participants. Les essais n'ont montré aucun événement indésirable grave lié au médicament.
TEPOXX agit en inhibant la protéine VP37 présente sur les orthopoxvirus, empêchant la propagation du virus à partir des cellules infectées. Le médicament est déjà approuvé aux États-Unis et au Canada pour le traitement de la variole, ainsi que dans l'UE et au Royaume-Uni pour la variole, l'mpox, la variole bovine et les complications de la vaccination.
SIGA Technologies gab bekannt, dass TEPOXX (tecovirimat) in Japan die Zulassung zur Behandlung von Orthopoxviren, einschließlich Pocken, Mpox und Rinderpocken, sowie Komplikationen nach der Pockenimpfung bei Erwachsenen und pädiatrischen Patienten mit einem Gewicht von mindestens 13 kg, erhalten hat. Dies ist die erste Zulassung eines Antivirals für Orthopoxviren in Japan.
SIGA hat mit Japan Biotechno Pharma einen Vertrag als exklusiven Distributor geschlossen und bereits TEPOXX an die strategische nationale Reserve Japans geliefert. Die Genehmigung basiert auf Daten aus 15 klinischen Studien mit mehr als 800 gesunden Probanden, darunter eine entscheidende Studie in Japan mit 20 Teilnehmern. In den Studien wurden keine schwerwiegenden unerwünschten Ereignisse festgestellt, die mit dem Medikament in Verbindung stehen.
TEPOXX wirkt, indem es das VP37-Protein hemmt, das bei Orthopoxviren vorkommt, und dadurch die Ausbreitung des Virus aus infizierten Zellen verhindert. Das Medikament ist bereits in den USA und Kanada zur Behandlung von Pocken zugelassen, sowie in der EU und dem Vereinigten Königreich für Pocken, Mpox, Rinderpocken und Impfkomplikationen.
- First approved antiviral treatment for orthopoxviruses in Japan
- Successfully delivered initial order to Japan's national stockpile
- Demonstrated strong safety profile with no serious adverse events in clinical trials
- Expanded geographic reach with approvals now in US, Canada, EU, UK, and Japan
- None.
Insights
The Japanese approval of TEPOXX represents a major regulatory milestone with significant market implications. The drug's unique position as the first approved antiviral treatment for orthopoxviruses in Japan creates a substantial competitive advantage. The comprehensive clinical data package, including 15 trials with over 800 participants and successful animal studies, strongly supports the drug's safety and efficacy profile.
The approval spans multiple indications including smallpox, mpox and cowpox, maximizing the product's commercial potential. The successful delivery to Japan's strategic stockpile suggests immediate revenue generation. The drug's long shelf-life and oral formulation are particularly valuable for stockpiling purposes, potentially leading to recurring orders for stockpile maintenance.
Simply put: This approval opens up a new market, provides immediate sales through stockpiling and positions SIGA strongly for future government contracts in Asia.
This regulatory victory unlocks significant revenue potential through two key channels: immediate stockpile orders and future commercial sales in Japan, the world's third-largest pharmaceutical market. The partnership with Japan Biotechno Pharma provides an established distribution network, important for market penetration.
The stockpiling aspect is particularly noteworthy as government contracts typically involve large-volume purchases with favorable margins. The long shelf-life of TEPOXX supports a sustainable business model with predictable replacement cycles. With approvals now spanning the US, EU, UK, Canada and Japan, SIGA has established a strong global presence that could attract additional international stockpiling contracts.
For non-experts: Think of this as securing a major government contract in one of the world's largest markets, with the potential for regular repeat orders due to stockpile maintenance requirements.
The PMDA approval carries strategic significance beyond Japan. This regulatory success, building on existing approvals in major markets (US, EU, UK, Canada), demonstrates TEPOXX's robust development program and could accelerate approvals in other Asian markets. The broader indication range compared to the US approval (where it's only approved for smallpox) is particularly valuable.
The pediatric indication for patients weighing ≥13 kg and the inclusion of vaccination complications in the label significantly expand the potential user base. The approval timing aligns with increased global focus on pandemic preparedness, potentially influencing other nations' stockpiling decisions.
In simple terms: This approval strengthens SIGA's global regulatory position and could lead to a domino effect of approvals and stockpiling contracts across Asia.
- Regulatory decision marks first approval in Japan of an antiviral for the treatment of orthopoxviruses including smallpox, mpox and cowpox
- Japan Biotechno Pharma Co., Ltd. engaged as exclusive distributor to supply TEPOXX to Japan’s national stockpile
- Comprehensive data package demonstrates strong safety profile and robust preclinical efficacy
NEW YORK, Jan. 02, 2025 (GLOBE NEWSWIRE) -- SIGA Technologies, a commercial stage pharmaceutical company, announced today that its antiviral treatment TEPOXX (tecovirimat 200 mg capsules), marketed as TPOXX in the United States, has received regulatory approval in Japan for the treatment of smallpox, mpox, cowpox, as well as complications following smallpox vaccination in adults and pediatric patients weighing at least 13 kg. TEPOXX is the first antiviral therapy approved by the Pharmaceuticals and Medical Devices Agency (PMDA), in collaboration with the Japan Ministry of Health, Labour and Welfare, for the treatment of orthopoxviruses.
In partnership with Japan Biotechno Pharma, SIGA’s exclusive distributor in Japan, SIGA has delivered an order of TEPOXX to help build Japan’s strategic national stockpile.
“The approval of TEPOXX in Japan marks another significant milestone in our mission to expand access to this critical antiviral treatment worldwide to support an effective response to an orthopoxvirus outbreak. As a capsule with a long shelf life, TEPOXX can easily be deployed in time sensitive emergencies,” said Diem Nguyen, Chief Executive Officer. “We are grateful for the close collaboration with the Japanese regulatory authorities and strong partnership with Japan Biotechno Pharma that made this accomplishment possible. This approval highlights the importance of stockpiling effective antiviral therapies as a cornerstone of innovative solutions to safeguard public health against serious and potentially devastating infectious diseases, such as smallpox.”
The Japanese approval is based on data from 15 clinical trials of oral TEPOXX in over 800 healthy volunteers, including a pivotal repeat-dose phase 1 pharmacokinetics (PK) trial involving 20 healthy volunteers conducted in Japan. These studies showed no drug-related serious adverse events and quantifiable PK within efficacious dose ranges. Four pivotal studies in non-human primates (NHPs) and two pivotal studies in rabbits demonstrated that TEPOXX significantly reduced both mortality and viral load. The results of the animal efficacy studies were published in the July 5, 2018 issue of the New England Journal of Medicine. TEPOXX has also been studied in NHPs infected with variola virus, the virus which causes smallpox, where TEPOXX demonstrated improved survival and reduction in lesions.
“This milestone reflects years of dedication and scientific innovation,” said Dennis Hruby, Ph.D., Chief Scientific Officer. “TEPOXX was designed with a deep understanding of orthopoxviruses and has the potential to deliver an effective treatment option for managing these potentially devastating diseases. We are proud to see our work contribute to enhanced preparedness and public health resilience in Japan.”
TEPOXX is a highly targeted small-molecule antiviral that inhibits the VP37 protein found on the surface of all orthopoxviruses. By preventing the virus from exiting infected cells, TEPOXX slows the spread of the infection, enabling the immune system to clear the virus.
TPOXX is approved in the U.S. and Canada for the treatment of smallpox. In the European Union and United Kingdom, marketed as Tecovirimat-SIGA, it is approved for the treatment of smallpox, mpox, cowpox, and to treat complications following smallpox vaccination.
ABOUT SIGA
SIGA is a commercial-stage pharmaceutical company and leader in global health focused on the development of innovative medicines to treat and prevent infectious diseases. With a primary focus on orthopoxviruses, we are dedicated to protecting humanity against the world’s most severe infectious diseases, including those that occur naturally, accidentally, or intentionally. Through partnerships with governments and public health agencies, we work to build a healthier and safer world by providing essential countermeasures against these global health threats. Our flagship product, TPOXX® (tecovirimat), is an antiviral medicine approved in the U.S. and Canada for the treatment of smallpox and authorized in Europe, the UK, and Japan for the treatment of smallpox, mpox (monkeypox), cowpox, and vaccinia complications. For more information about SIGA, visit www.siga.com.
FORWARD-LOOKING STATEMENTS
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements relating to SIGA’s future business development and plans including with respect to future sales of TEPOXX in Japan. Forward-looking statements include statements regarding our future financial position, business strategy, budgets, projected costs, plans and objectives of management for future operations. The words “may,” “continue,” “estimate,” “intend,” “plan,” “will,” “believe,” “project,” “expect,” “seek,” “anticipate,” “could,” “should,” “target,” “goal,” “potential” and similar expressions may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. Such forward-looking statements are subject to various known and unknown risks and uncertainties, and SIGA cautions you that any forward-looking information provided by or on behalf of SIGA is not a guarantee of future performance. SIGA’s actual results could differ materially from those anticipated by such forward-looking statements due to a number of factors, some of which are beyond SIGA’s control, including, but not limited to, (i) the risk that BARDA elects, in its sole discretion as permitted under the 75A50118C00019 BARDA Contract (the “BARDA Contract”), not to exercise the remaining unexercised option under the BARDA Contract, (ii) the risk that SIGA may not complete performance under the BARDA Contract on schedule or in accordance with contractual terms, (iii) the risk that the BARDA Contract or U.S. Department of Defense contracts are modified or canceled at the request or requirement of, or SIGA is not able to enter into new contracts to supply TPOXX to, the U.S. Government, (iv) the risk that the nascent international biodefense market does not develop to a degree that allows SIGA to continue to successfully market TPOXX internationally, (v) the risk that potential products, including potential alternative uses or formulations of TPOXX that appear promising to SIGA or its collaborators, cannot be shown to be efficacious or safe in subsequent pre-clinical or clinical trials, (vi) the risk that target timing for deliveries of product to customers, and the recognition of related revenues, are delayed or adversely impacted by the actions, or inaction, of contract manufacturing organizations, or other vendors, within the supply chain, or due to coordination activities between the customer and supply chain vendors, (vii) the risk that SIGA or its collaborators will not obtain appropriate or necessary governmental approvals to market these or other potential products or uses, (viii) the risk that SIGA may not be able to secure or enforce sufficient legal rights in its products, including intellectual property protection, (ix) the risk that any challenge to SIGA’s patent and other property rights, if adversely determined, could affect SIGA’s business and, even if determined favorably, could be costly, (x) the risk that regulatory requirements applicable to SIGA’s products may result in the need for further or additional testing or documentation that will delay or prevent SIGA from seeking or obtaining needed approvals to market these products, (xi) the risk that the volatile and competitive nature of the biotechnology industry may hamper SIGA’s efforts to develop or market its products, (xii) the risk that changes in domestic or foreign economic and market conditions may affect SIGA’s ability to advance its research or may affect its products adversely, (xiii) the effect of federal, state, and foreign regulation, including drug regulation and international trade regulation, on SIGA’s businesses, (xiv) the risk of disruptions to SIGA’s supply chain for the manufacture of TPOXX®, causing delays in SIGA’s research and development activities, causing delays or the re-allocation of funding in connection with SIGA’s government contracts, or diverting the attention of government staff overseeing SIGA’s government contracts, (xv) risks associated with actions or uncertainties surrounding the debt ceiling, (xvi) the risk that the U.S. or foreign governments' responses (including inaction) to national or global economic conditions or infectious diseases, are ineffective and may adversely affect SIGA’s business, and (xvii) risks associated with responding to an mpox outbreak, as well as the risks and uncertainties included in Item 1A “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2023 and SIGA's subsequent filings with the Securities and Exchange Commission. SIGA urges investors and security holders to read those documents free of charge at the SEC's website at http://www.sec.gov. All such forward-looking statements are current only as of the date on which such statements were made. SIGA does not undertake any obligation to update publicly any forward-looking statement to reflect events or circumstances after the date on which any such statement is made or to reflect the occurrence of unanticipated events.
Contacts:
Suzanne Harnett
sharnett@siga.com
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FAQ
What conditions has TEPOXX been approved to treat in Japan?
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