Tharimmune Secures Key Global Patents for TH-104, Laying Foundation for Broader Indications Following Initial Development as a National Security Medical Countermeasure Against Weaponized Fentanyl
Tharimmune (Nasdaq:THAR) has secured significant global patent protection for TH-104, its novel transmucosal film technology, extending coverage until at least 2040. The patents, granted in Japan, Mexico, Australia, and the United States, cover a unique method for administering nalmefene via a single-layer, mucoadhesive film.
The FDA has provided positive feedback on TH-104's NDA pathway, confirming that a 505(b)(2) submission is viable for preventing respiratory and CNS distress, with no additional clinical trials required for military and first responder use against weaponized opioids. The drug features a longer half-life compared to existing alternatives like Narcan庐, potentially providing sustained protection in high-risk environments.
Tharimmune (Nasdaq:THAR) ha ottenuto una significativa protezione brevettuale globale per TH-104, la sua innovativa tecnologia a film transmucoso, estendendo la copertura almeno fino al 2040. I brevetti, concessi in Giappone, Messico, Australia e Stati Uniti, riguardano un metodo esclusivo per somministrare nalmefene tramite un film monostrato mucoadesivo.
La FDA ha fornito riscontri positivi sul percorso NDA di TH-104, confermando che una presentazione 505(b)(2) 猫 percorribile per prevenire compromissioni respiratorie e del sistema nervoso centrale, senza richiedere ulteriori studi clinici per l'uso da parte di militari e soccorritori contro oppioidi impiegati come armi. Il farmaco presenta un'emivita pi霉 lunga rispetto ad alternative esistenti come Narcan庐, offrendo una potenziale protezione prolungata in ambienti ad alto rischio.
Tharimmune (Nasdaq:THAR) ha asegurado una amplia protecci贸n por patente a nivel global para TH-104, su novedosa tecnolog铆a de pel铆cula transmucosal, extendiendo la cobertura al menos hasta 2040. Las patentes, concedidas en Jap贸n, M茅xico, Australia y Estados Unidos, cubren un m茅todo 煤nico para administrar nalmefeno mediante una pel铆cula monocapa mucoadhesiva.
La FDA ha dado una respuesta favorable sobre la v铆a NDA para TH-104, confirmando que una presentaci贸n 505(b)(2) es viable para prevenir el deterioro respiratorio y del sistema nervioso central, sin requerir ensayos cl铆nicos adicionales para el uso por militares y servicios de emergencia frente a opioides empleados como armas. El f谩rmaco presenta una vida media m谩s larga en comparaci贸n con alternativas como Narcan庐, lo que podr铆a ofrecer protecci贸n sostenida en entornos de alto riesgo.
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FDA電� TH-104鞚� NDA 鞝堨皑鞐� 雽�頃� 旮嶌爼鞝侅澑 頂茧摐氚膘潉 鞝滌嫓頄堨溂氅�, 505(b)(2) 鞝滌稖鞚� 順疙潯旮� 氚� 欷戩稊鞁犼步瓿� 靻愳儊鞚� 鞓堧癌頃橂姅 雿� 鞁ろ槃 臧�電ロ晿雼り碃 頇曥澑頄堨姷雼堧嫟. 氍搓赴頇旊悳 鞓ろ敿鞓れ澊霌滌棎 雽�牍勴暅 甑� 氚� 齑堧彊 雽�鞚� 鞚鸽牓鞚� 靷毄鞐� 雽�頃� 於旉皜 鞛勳儊鞁滍棙鞚� 頃勳殧頃橃 鞎婌姷雼堧嫟. 鞚� 鞎诫鞚� Narcan庐 霌� 旮办〈 雽�鞎堧炒雼� 氚橁皭旮瓣皜 旮胳柎 瓿犾渼項� 頇橁步鞐愳劀 歆�靻嶌爜鞚� 氤错樃毳� 鞝滉车頃� 臧�電レ劚鞚� 鞛堨姷雼堧嫟.
Tharimmune (Nasdaq:THAR) a obtenu une protection par brevet mondiale importante pour TH-104, sa nouvelle technologie de film transmucosal, prolongeant la couverture au moins jusqu'en 2040. Les brevets, d茅livr茅s au Japon, au Mexique, en Australie et aux 脡tats-Unis, couvrent une m茅thode unique d'administration du nalmef猫ne via un film mucoadh茅sif monocouche.
La FDA a formul茅 des retours positifs sur la voie NDA pour TH-104, confirmant qu'un d茅p么t 505(b)(2) est viable pour pr茅venir les d茅tresses respiratoires et du syst猫me nerveux central, sans essais cliniques suppl茅mentaires requis pour une utilisation par les militaires et les premiers intervenants contre des opio茂des militaris茅s. Le m茅dicament pr茅sente une demi-vie plus longue que des alternatives existantes comme Narcan庐, ce qui pourrait assurer une protection prolong茅e dans des environnements 脿 haut risque.
Tharimmune (Nasdaq:THAR) hat f眉r TH-104, seine neuartige transmukosale Filmtechnologie, einen umfangreichen weltweiten Patentschutz erlangt, der die Abdeckung mindestens bis 2040 verl盲ngert. Die in Japan, Mexiko, Australien und den Vereinigten Staaten erteilten Patente betreffen ein einzigartiges Verfahren zur Verabreichung von Nalmefen mittels einer einlagigen, schleimhauthaftenden Folie.
Die FDA hat positives Feedback zum NDA-Verfahren f眉r TH-104 gegeben und best盲tigt, dass eine 505(b)(2)-Einreichung praktikabel ist, um Atemwegs- und ZNS-Beeintr盲chtigungen zu verhindern; f眉r den Einsatz durch Milit盲r und Ersthelfer gegen als Waffen eingesetzte Opioide sind keine zus盲tzlichen klinischen Studien erforderlich. Das Medikament hat eine l盲ngere Halbwertszeit im Vergleich zu bestehenden Alternativen wie Narcan庐 und k枚nnte in Hochrisikoumgebungen einen anhaltenden Schutz bieten.
- FDA confirms no additional clinical trials needed for 505(b)(2) NDA submission
- Patent protection secured until 2040 across key global markets (US, Japan, Mexico, Australia)
- TH-104 offers longer half-life compared to existing opioid antagonist options
- Technology platform has potential for multiple high-impact indications beyond initial military use
- None.
Insights
Tharimmune strengthens TH-104's global IP protection through 2040, securing both military applications and future commercial opportunities.
The patent grants and allowances secured by Tharimmune across four major markets (US, Japan, Mexico, and Australia) represent a significant strategic achievement for their TH-104 platform. These patents specifically protect their novel transmucosal film delivery system for nalmefene until at least 2040, creating substantial exclusivity for both their initial national security application and future indications.
What makes these patents particularly valuable is their comprehensive scope - covering both method and device claims for a single-layer, self-supporting mucoadhesive film with distinct domains for optimized drug delivery and pH balance. This broad protection creates multiple barriers to potential competitors attempting to develop similar delivery mechanisms.
The FDA's confirmation of the 505(b)(2) pathway without additional clinical trials significantly de-risks and accelerates TH-104's development timeline for its initial indication. This regulatory efficiency, combined with the extended patent runway, creates an unusual dual advantage - rapid near-term revenue potential from government/security contracts while preserving long-term commercial exclusivity for broader medical applications like pruritus treatment.
From a competitive positioning standpoint, TH-104's extended half-life compared to existing options (like Narcan庐) addresses a critical limitation in current medical countermeasures against high-potency opioids. The buccal film delivery format also offers significant practical advantages for first responders and military personnel operating in high-stress environments where traditional injection methods may be impractical.
Tharimmune's progress with TH-104 addresses a critical national security gap in protection against weaponized fentanyl and related compounds. The current threat landscape has evolved significantly, with high-potency synthetic opioids emerging as potential chemical weapons that can be deployed against military personnel or first responders.
The key advancement here is the development of a sustained-protection countermeasure. Standard naloxone products (like Narcan庐) have limited duration of action - approximately 30-90 minutes - creating a dangerous protection gap when personnel face extended exposure scenarios or delayed medical evacuation. TH-104's nalmefene formulation provides significantly longer protection, potentially preventing fatal respiratory depression during critical operational windows.
The FDA's confirmation that no additional clinical trials are needed for the 505(b)(2) pathway specifically for military/first responder use represents an unusual regulatory accommodation that reflects the national security importance of this technology. This expedited pathway is typically reserved for products addressing urgent public health or security needs.
The appointment of counter-terrorism expert James Liddy further signals Tharimmune's strategic pivot toward positioning TH-104 as a dual-use technology with both military and civilian applications. This approach enhances procurement potential through multiple government channels including DoD, DHS, and various first responder agencies.
The buccal film format offers significant tactical advantages over autoinjectors in field conditions - it can be self-administered without removing protective gear, requires minimal training, and avoids the logistical challenges of sharps disposal in operational environments.
RED BANK, NEW JERSEY / / August 13, 2025 / Tharimmune, Inc. (Nasdaq:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company dedicated to developing innovative therapeutic candidates for inflammation, immunology, and critical unmet medical needs, today announced a significant expansion of its intellectual property portfolio for TH-104, its novel transmucosal film. The new patents, recently granted and allowed across key global markets, will enable the Company's long-term strategy of pursuing broader indications for the technology, beginning with its lead program as a critical medical countermeasure for military and first responders against high-potency opioids.
This announcement follows recent positive feedback from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) pathway for TH-104. The FDA confirmed that a 505(b)(2) NDA submission for the prevention of respiratory and/or central nervous system distress is a viable path, and no additional clinical trials seem to be required for this specific indication for use in military personnel and/or first responders who may be exposed to weaponized high-potency opioids, such as fentanyl or its analogues. This positive feedback, combined with the appointment of counter-terrorism expert James Liddy to the Board of Directors, accelerates the Company's efforts to position TH-104 as a national security solution.
The recent granting and allowance of patents in Japan, Mexico, Australia, and the United States further strengthen the Company's intellectual property position, providing protection for TH-104 out to at least 2040 in key markets. While the initial focus is on military and first responders, these patents are foundational for addressing other significant medical needs to combat pruritus, a debilitating form of itch associated with certain chronic liver and kidney diseases.
TH-104 is a buccal film formulation of nalmefene, an opioid antagonist with a significantly longer half-life compared to existing options of autoinjectors and other formulations containing the active ingredient of products such as Narcan庐. This extended duration may provide sustained protection, which is crucial for personnel operating in high-risk environments where repeated dosing may not be feasible.
"The recent patent grants are important for our TH-104 platform," said Sireesh Appajosyula, CEO of Tharimmune. "This is a dual achievement which validates our innovative drug delivery technology and secures the long-term potential of TH-104 to address multiple high-impact indications. While we are prioritizing its role as a life-saving medical countermeasure for our military and first responders, this patent portfolio provides a runway to develop our lead candidate for other debilitating conditions where there is a significant unmet medical need."
The newly granted and allowed patents specifically cover a novel method and device for transmucosal administration of nalmefene via a single-layer, self-supporting, mucoadhesive film with distinct domains for optimized drug delivery and pH balance.
The granted and allowed patents include:
United States (US) Application No. 17/285,971 (Allowed)
Japan (JP) Patent No. 7603583 (Granted)
Mexico (MX) Patent No. 422769 (Granted)
Australia (AU) Patent Application No. 2019361980 (Allowed)
Tharimmune is dedicated to advancing TH-104 to provide a potentially effective and patient-friendly treatment as an option for those in need, beginning with its critical role in national security.
About Tharimmune, Inc.
Tharimmune is a clinical-stage biotechnology company developing a diverse portfolio of therapeutic candidates in immunology, inflammation and oncology. Its lead clinical asset, TH104, is being developed for a specific indication via a 505(b)2 pathway for respiratory and/or nervous system depression in military personnel and chemical incident responders who may encounter environments contaminated with high-potency opioids. The expanded pipeline includes other indications for TH104, such as chronic pruritus in primary biliary cholangitis and TH023, a new approach to treating autoimmune diseases along with an early-stage multispecific biologic platform targeting unique epitopes against multiple solid tumors through its proprietary EpiClick鈩� Technology. The Company has a license agreement with OmniAb, Inc. to access their antibody discovery technology for targeting specified disease markers. Tharimmune continues to position itself as a leader in patient-centered innovation while working to deliver long-term value for shareholders. For more information, visit: .
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, contained in this press release, including statements regarding the timing and design of Tharimmune's future Phase 2 trial, Tharimmune's strategy, future operations, future financial position, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "continue," "could," "depends," "estimate," "expect," "intend," "may," "ongoing," "plan," "potential," "predict," "project," "target," "should," "will," "would," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements. Factors that may cause such differences, include, but are not limited to, those discussed under Risk Factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2024 and other periodic reports filed by the Company from time to time with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this release. Subsequent events and developments may cause the Company's views to change; however, the Company does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this release.
Contacts:
Tharimmune, Inc.
[email protected]
SOURCE: Tharimmune Inc.
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