Hetero Signs Voluntary Licensing Agreement with Gilead to Transform Global HIV response, Expanding Access to Groundbreaking Lenacapavir to 120 high-incidence countries
Hetero, a leading Indian pharmaceutical company, has signed a non-exclusive, royalty-free voluntary licensing agreement with Gilead Sciences to manufacture and distribute lenacapavir in 120 primarily low- and lower-middle income countries. This partnership aims to expand access to this innovative HIV treatment and prevention drug in high-incidence, resource- areas.
Lenacapavir is a breakthrough HIV-1 capsid inhibitor that works with other antiretrovirals to treat multi-drug-resistant HIV-1 infections. Recent clinical trials showed it reduced HIV infections by 96% compared to background incidence. The drug can be administered every six months via subcutaneous injection, making it a promising long-acting option for both treatment and prevention.
Hetero, with its extensive experience in HIV/AIDS care, plans to leverage its research, manufacturing, and distribution capabilities to rapidly expand access to affordable lenacapavir in underserved regions.
Hetero, una delle principali compagnie farmaceutiche indiane, ha firmato un accordo di licenza volontaria non esclusiva e senza royalty con Gilead Sciences per produrre e distribuire lenacapavir in 120 paesi principalmente a basso e medio-basso reddito. Questa collaborazione mira a espandere l'accesso a questo farmaco innovativo per il trattamento e la prevenzione dell'HIV in aree ad alta incidenza e con risorse limitate.
Lenacapavir è un inibitore innovativo della capsula dell'HIV-1 che agisce in sinergia con altri antiretrovirali per trattare infezioni da HIV-1 multi-resistenti. Recenti studi clinici hanno dimostrato che riduce le infezioni da HIV del 96% rispetto all'incidenza di base. Il farmaco può essere somministrato ogni sei mesi tramite iniezione sottocutanea, rendendolo un'opzione promettente a lunga durata sia per il trattamento che per la prevenzione.
Hetero, con la sua vasta esperienza nella cura dell'HIV/AIDS, prevede di sfruttare le proprie capacità di ricerca, produzione e distribuzione per espandere rapidamente l'accesso a lenacapavir a prezzi accessibili nelle regioni sottoservite.
Hetero, una de las principales compañías farmacéuticas indias, ha firmado un acuerdo de licencia voluntaria no exclusiva y sin regalías con Gilead Sciences para fabricar y distribuir lenacapavir en 120 países, principalmente de ingresos bajos y medianos bajos. Esta asociación tiene como objetivo ampliar el acceso a este medicamento innovador para el tratamiento y prevención del VIH en áreas de alta incidencia y con recursos limitados.
Lenacapavir es un inhibidor innovador de la cápside del VIH-1 que trabaja con otros antirretrovirales para tratar infecciones por VIH-1 multirresistentes. Los ensayos clínicos recientes mostraron que redujo las infecciones por VIH en un 96% en comparación con la incidencia de fondo. El medicamento puede ser administrado cada seis meses mediante inyección subcutánea, lo que lo convierte en una opción prometedora de acción prolongada tanto para el tratamiento como para la prevención.
Hetero, con su vasta experiencia en el cuidado del VIH/SIDA, planea aprovechar sus capacidades de investigación, fabricación y distribución para expandir rápidamente el acceso a lenacapavir a precios asequibles en las regiones desatendidas.
Hetero는 인도의 선두 제약회사로, Gilead Sciences와 비독점적이며 로열티 없는 자발적 라이센스 계약을 체결하여 lenacapavir를 주로 저소득 및 중간 저소득 국가 120곳에서 제조 및 유통하는 역할을 하게 됩니다. 이 파트너십의 목적은 높은 유행률과 자원이 제한된 지역에서 이 혁신적인 HIV 치료 및 예방 약물에 대한 접근을 확대하는 것입니다.
Lenacapavir는 HIV-1 캡시드 억제제로, 다른 항retrovirals와 함께 작용하여 다제내성과 HIV-1 감염을 치료합니다. 최근의 임상 시험에서는 배경 발생률과 비교하여 HIV 감염을 96% 감소시켰다고 보여졌습니다. 이 약물은 피하 주사를 통해 6개월마다 투여할 수 있어, 치료와 예방 모두를 위한 유망한 장기 작용 옵션입니다.
Hetero는 HIV/AIDS 관리에 대한 넓은 경험을 바탕으로 연구, 제조 및 유통 능력을 활용하여 소외된 지역에서 저렴한 lenacapavir에 대한 접근을 신속하게 확대할 계획입니다.
Hetero, une entreprise pharmaceutique indienne de premier plan, a signé un accord de licence volontaire non exclusif et sans redevances avec Gilead Sciences pour fabriquer et distribuer lenacapavir dans 120 pays principalement à revenus faibles et intermédiaires. Ce partenariat vise à élargir l'accès à ce médicament innovant pour le traitement et la prévention du VIH dans des zones à forte incidence et à ressources limitées.
Lenacapavir est un inhibiteur révolutionnaire de la capside du VIH-1 qui agit avec d'autres antirétroviraux pour traiter les infections VIH-1 multirésistantes. Les essais cliniques récents ont montré qu'il réduisait les infections à VIH de 96% par rapport à l'incidence de base. Le médicament peut être administré tous les six mois par injection sous-cutanée, ce qui en fait une option prometteuse à action prolongée tant pour le traitement que pour la prévention.
Hetero, forte de sa grande expérience dans les soins du VIH/SIDA, prévoit de tirer parti de ses capacités de recherche, de fabrication et de distribution pour élargir rapidement l'accès à lenacapavir à des prix abordables dans les régions défavorisées.
Hetero, ein führendes indisches Pharmaunternehmen, hat eine nicht-exklusive, royaltyfreie freiwillige Lizenzvereinbarung mit Gilead Sciences unterzeichnet, um lenacapavir in 120 primär niedrig- und niedrig-mittleren Einkommensländern herzustellen und zu vertreiben. Diese Partnerschaft zielt darauf ab, den Zugang zu diesem innovativen Medikament zur Behandlung und Prävention von HIV in Gebieten mit hoher Inzidenz und begrenzten Ressourcen zu erweitern.
Lenacapavir ist ein bahnbrechender Inhibitor des HIV-1-Kapsids, der in Kombination mit anderen Antiretroviralia zur Behandlung von multi-resistenten HIV-1-Infektionen eingesetzt wird. Neueste klinische Studien zeigten, dass es die HIV-Infektionen um 96% im Vergleich zur Hintergrundinzidenz reduzierte. Das Medikament kann alle sechs Monate durch subkutane Injektion verabreicht werden und stellt somit eine vielversprechende langfristige Option für die Behandlung und Prävention dar.
Hetero plant, seine umfangreiche Erfahrung in der HIV/AIDS-Versorgung zu nutzen, um mit seinen Forschungs-, Produktions- und Verteilungskapazitäten den Zugang zu erschwinglichem Lenacapavir in unterversorgten Regionen schnell zu erweitern.
- Non-exclusive, royalty-free licensing agreement expands access to innovative HIV treatment in 120 countries
- Lenacapavir showed 96% reduction in HIV infections in clinical trials
- Long-acting formulation allows administration every six months, improving treatment adherence
- Partnership leverages Hetero's extensive experience and capabilities in HIV/AIDS care
- Lenacapavir is not yet approved globally for HIV prevention use
Insights
This licensing agreement between Hetero and Gilead is a significant development in the global fight against HIV/AIDS. Lenacapavir, as a breakthrough HIV-1 capsid inhibitor, offers a new mechanism of action for treating multi-drug resistant HIV infections. The expansion to 120 low- and lower-middle income countries could dramatically increase access to this innovative treatment.
Key points to consider:
- Potential for substantial market expansion in developing countries
- Long-acting formulation (every six months) could improve patient adherence
- 96% reduction in HIV infections in clinical trials is extremely promising
- Dual use for both treatment and prevention could drive adoption
While this agreement may impact Gilead's revenue potential in these markets, it aligns with global health initiatives and could enhance the company's reputation. The long-term benefits of expanded access and potential market growth in emerging economies may outweigh short-term revenue considerations.
This agreement represents a major step forward in global HIV prevention and treatment efforts. By partnering with Hetero, a company with extensive reach in low- and middle-income countries, Gilead is significantly expanding access to cutting-edge HIV medication.
The impact of this deal extends beyond immediate treatment options:
- Potential to reduce HIV transmission rates in high-incidence areas
- May alleviate strain on healthcare systems in resource- settings
- Could serve as a model for future pharmaceutical collaborations in global health
The long-acting nature of lenacapavir (administered every six months) is particularly valuable in regions with healthcare infrastructure. This could lead to improved adherence and better overall outcomes in HIV management across these 120 countries.
- Non-exclusive voluntary license agreement enables the manufacture and distribution of lenacapavir for HIV prevention and treatment of heavily treatment-experienced patients with multi drug-resistant HIV
This collaboration marks a significant step in expanding access to life-saving treatments for heavily treatment-experienced patients with multi-drug-resistant HIV and offers a promising option for HIV prevention in underserved regions. Lenacapavir is a breakthrough HIV-1 capsid inhibitor that works with other antiretroviral drugs to treat multi-drug-resistant HIV-1 infections. It has a unique ability to target multiple stages of the HIV lifecycle, making it highly effective for patients with limited treatment options.
Expanding Access to Affordable HIV Treatment
Dr. Vamsi Krishna Bandi, Managing Director of Hetero Group of Companies, emphasized: "This partnership with Gilead Sciences strengthens our resolve to push the boundaries of HIV prevention and treatment. For over three decades, Hetero has been at the forefront of the global fight against HIV/AIDS, pioneering affordable, life-saving treatments where the need is greatest. With over 30 combinations addressing nearly
By leveraging our strong research focus, unparalleled manufacturing scale and distribution expertise, we are primed to rapidly expand access to lenacapavir in all 120 high-incidence, resource-limited countries. With our generic lenacapavir, we will reach communities beyond the usual access points, ensuring that even in the most underserved and remote areas, people receive the effective and affordable HIV prevention and treatment they deserve, he added.
Groundbreaking Clinical Results
Earlier this month, Gilead announced promising results from a pivotal Phase 3 clinical trial. The interim analysis demonstrated that lenacapavir reduced HIV infections by
Lenacapavir is also being studied as a long-acting HIV prevention drug in ongoing clinical trials. This drug's long-acting version can be administered every six months via a subcutaneous injection, following an initial oral loading dose. Lenacapavir was approved for use in HIV-positive adults with multi-drug resistance by the European Union in August 2022 and received
About Hetero
Hetero is a globally renowned vertically integrated pharmaceutical organization engaged in research and development, manufacturing, and marketing of high-quality chemical and biologic medicines across diverse therapeutic areas. Backed by 30+ years of expertise in the pharmaceutical industry, Hetero's strategic business areas spread across APIs, Global Generics, Biosimilars and Custom Pharmaceutical Services. The company is among the largest producers of Active Pharmaceutical Ingredients (APIs) in the world. For more information on Hetero, please visit www.hetero.com.
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FAQ
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