Gilead Signs Royalty-Free Voluntary Licensing Agreements With Six Generic Manufacturers to Increase Access to Lenacapavir for HIV Prevention in High-Incidence, Resource-Limited Countries
Gilead Sciences (GILD) has signed royalty-free voluntary licensing agreements with six generic manufacturers to increase access to lenacapavir for HIV prevention in 120 high-incidence, resource- countries. The agreements cover lenacapavir for HIV prevention and treatment in heavily treatment-experienced adults with multi-drug resistant HIV.
Gilead plans to price the product at no profit and supply lenacapavir until generic manufacturers fully support demand. The company will prioritize registration in 18 countries representing about 70% of the HIV burden in the licensed territories. Gilead aims to begin regulatory filings for lenacapavir for PrEP by the end of 2024, based on positive results from two pivotal Phase 3 trials.
This strategy aligns with Gilead's vision of ending the HIV epidemic globally and reflects input from over 100 global health stakeholders.
Gilead Sciences (GILD) ha firmato accordi di licenza volontaria senza royalty con sei produttori generici per aumentare l'accesso a lenacapavir per la prevenzione dell'HIV in 120 paesi ad alta incidenza e risorse limitate. Gli accordi riguardano lenacapavir per la prevenzione dell'HIV e il trattamento in adulti con esperienza di trattamento avanzata e HIV multi-resistente.
Gilead prevede di prezzare il prodotto senza profitto e fornire lenacapavir fino a quando i produttori generici non supporteranno completamente la domanda. L'azienda darà priorità alla registrazione in 18 paesi che rappresentano circa il 70% dell'onere dell'HIV nei territori con licenza. Gilead punta a iniziare le pratiche normative per lenacapavir per PrEP entro la fine del 2024, basandosi su risultati positivi di due studi clinici di fase 3 fondamentali.
Questa strategia è in linea con la visione di Gilead di porre fine all'epidemia di HIV a livello globale e riflette i contributi di oltre 100 attori della salute globale.
Gilead Sciences (GILD) ha firmado acuerdos de licencia voluntaria sin regalías con seis fabricantes genéricos para aumentar el acceso a lenacapavir para la prevención del VIH en 120 países de alta incidencia y recursos limitados. Los acuerdos cubren lenacapavir para la prevención del VIH y el tratamiento en adultos con una gran experiencia en tratamientos y VIH resistente a múltiples fármacos.
Gilead planea fijar el precio del producto sin ganancias y suministrar lenacapavir hasta que los fabricantes genéricos puedan satisfacer plenamente la demanda. La empresa priorizará la inscripción en 18 países que representan aproximadamente el 70% de la carga del VIH en los territorios con licencia. Gilead tiene como objetivo comenzar a presentar los documentos regulatorios para lenacapavir para PrEP antes de finales de 2024, basándose en resultados positivos de dos ensayos clínicos de fase 3 decisivos.
Esta estrategia se alinea con la visión de Gilead de poner fin a la epidemia de VIH a nivel global y refleja las aportaciones de más de 100 partes interesadas en salud global.
길리어드 사이언스(GILD)는 120개의 고발생 자원 부족 국가에서 HIV 예방을 위한 레나카파비르에 대한 접근성을 높이기 위해 6개의 제네릭 제조업체와 로열티 없는 자발적 라이센스 계약을 체결했습니다. 이 계약은 다제내성 HIV와 관련된 치료 경험이 풍부한 성인을 위한 HIV 예방 및 치료의 레나카파비르를 포함합니다.
길리어드는 제품 가격을 이윤 없이 설정하고 제네릭 제조업체가 수요를 완전히 지원할 때까지 레나카파비르를 공급할 계획입니다. 이 회사는 라이센스 지역의 HIV 부담의 약 70%를 차지하는 18개 국가에서 등록을 우선시할 것입니다. 길리어드는 두 건의 주요 3상 임상 시험의 긍정적 결과를 기반으로 2024년 말까지 PrEP용 레나카파비르의 규제 제출을 시작할 계획입니다.
이 전략은 전 세계 HIV 유행종식이라는 길리어드의 비전과 일치하며, 100명 이상의 글로벌 건강 이해관계자들의 의견을 반영합니다.
Gilead Sciences (GILD) a signé des accords de licence volontaires sans redevance avec six fabricants génériques pour accroître l'accès à lenacapavir pour la prévention du VIH dans 120 pays à forte incidence et à ressources limitées. Les accords portent sur lenacapavir pour la prévention du VIH et le traitement chez les adultes fortement expérimentés en traitement et porteurs d'un VIH multirésistant.
Gilead prévoit de fixer le prix du produit sans bénéfice et de fournir lenacapavir jusqu'à ce que les fabricants génériques puissent entièrement satisfaire la demande. L'entreprise donnera la priorité à l'enregistrement dans 18 pays représentant environ 70 % de la charge VIH dans les territoires sous licence. Gilead vise à commencer les dépôts réglementaires pour lenacapavir pour PrEP d'ici la fin de 2024, en s'appuyant sur des résultats positifs de deux essais cliniques de phase 3 déterminants.
Cette stratégie est en accord avec la vision de Gilead de mettre fin à l'épidémie de VIH à l'échelle mondiale et reflète l'avis de plus de 100 intervenants en matière de santé mondiale.
Gilead Sciences (GILD) hat lizenzfreie freiwillige Lizenzverträge mit sechs Generikaherstellern unterzeichnet, um den Zugang zu Lenacapavir zur HIV-Prävention in 120 Ländern mit hoher Inzidenz und begrenzten Ressourcen zu erhöhen. Die Vereinbarungen decken Lenacapavir für HIV-Prävention und Behandlungen bei stark behandelten Erwachsenen mit multiresistentem HIV ab.
Gilead plant, das Produkt zum Selbstkostenpreis anzubieten und Lenacapavir zu liefern, bis die Generikahersteller die Nachfrage vollständig decken können. Das Unternehmen wird die Registrierung in 18 Ländern priorisieren, die etwa 70 % der HIV-Belastung in den lizenzierten Gebieten ausmachen. Gilead beabsichtigt, bis Ende 2024 mit die Zulassungsanträge für Lenacapavir zur PrEP zu beginnen, basierend auf positiven Ergebnissen aus zwei wegweisenden Phase-3-Studien.
Diese Strategie steht im Einklang mit Gileads Vision, die globale HIV-Epidemie zu beenden, und spiegelt die Perspektiven von über 100 globalen Gesundheitsakteuren wider.
- Royalty-free licensing agreements with six generic manufacturers for lenacapavir
- Expanding access to HIV prevention in 120 high-incidence, resource- countries
- Pricing product at no profit to ensure affordability
- Positive results from two pivotal Phase 3 trials for lenacapavir in PrEP
- Prioritizing registration in 18 countries representing 70% of HIV burden in licensed territories
- None.
Insights
This agreement represents a significant step in expanding access to HIV prevention in high-risk, resource- areas. By partnering with six generic manufacturers, Gilead is facilitating the production of low-cost versions of lenacapavir for 120 primarily low- and lower-middle income countries. This approach could dramatically increase the availability of this potentially game-changing HIV prevention medication.
The strategy involves:
- Royalty-free licensing agreements
- Gilead supplying the product at no profit until generic manufacturers can meet demand
- Prioritizing registration in 18 high-incidence countries
This multi-faceted approach demonstrates Gilead's commitment to global health equity. By addressing both manufacturing and regulatory hurdles proactively, they're setting the stage for rapid deployment if lenacapavir receives approval for PrEP. The inclusion of treatment provisions for heavily treatment-experienced patients further broadens the potential impact.
While the full impact remains to be seen, this move aligns with best practices in global health policy and could significantly advance HIV prevention efforts in areas of high need.
Gilead's strategy with lenacapavir demonstrates a forward-thinking approach to both market expansion and corporate social responsibility. Key points for investors:
- Market Expansion: By facilitating early generic entry in 120 countries, Gilead is laying groundwork for rapid market penetration in emerging economies.
- Regulatory Strategy: Prioritizing registration in 18 high-burden countries representing
70% of the HIV burden in licensed territories shows a targeted approach to market entry. - Pipeline Value: Positive early results from PURPOSE 1 and 2 trials suggest strong potential for lenacapavir in PrEP, enhancing Gilead's HIV portfolio.
- Long-term Growth: While initial supply will be at no profit, this move positions Gilead as a leader in next-generation HIV prevention, potentially driving long-term revenue growth and market share.
This approach may impact short-term profitability but could yield significant long-term benefits in market position and reputation. It also mitigates risks associated with generic competition by proactively managing the process. Investors should view this as a strategic investment in Gilead's future market leadership in HIV prevention and treatment.
– License for Companies to Manufacture and Supply High-Quality, Low-Cost Versions of Lenacapavir for 120 Primarily Low- and Lower-Middle Income Countries –
– Gilead Plans to Price Product at No Profit to the Company and Supply Lenacapavir Until Generic Manufacturers Fully Support Demand –
– Agreements Also Cover Lenacapavir for HIV Treatment in Heavily Treatment-Experienced Adults with Multi-Drug Resistant HIV –
The agreements advance Gilead’s strategy to enable broad, sustainable access to lenacapavir for pre-exposure prophylaxis (PrEP) globally if it is approved, and align with Gilead’s vision of ending the HIV epidemic for everyone, everywhere. Gilead will support low-cost access to the drug in high-incidence, resource-limited countries through a two-part strategy: establishing a robust voluntary licensing program, and planning to provide Gilead-supplied product at no profit to Gilead until generic manufacturers are able to fully support demand. Additionally, the agreements cover not only lenacapavir for HIV prevention (pending approval), but also lenacapavir for HIV treatment in heavily treatment-experienced (HTE) adults with multi-drug resistant HIV.
“Given the transformative potential of lenacapavir for prevention, our focus is on making it available as quickly and broadly as possible where the need is greatest,” said Daniel O’Day, Chairman and Chief Executive Officer of Gilead. “Gilead teams have been working with urgency to bring on high-volume generic manufacturers now, so that we can ensure a rapid transition to these voluntary license partners after lenacapavir for PrEP is approved.”
The generic companies that will manufacture and supply lenacapavir to the 120 countries are Dr. Reddy’s Laboratories Limited, Emcure, Eva Pharma, Ferozsons Laboratories Limited, Hetero and Mylan, a subsidiary of Viatris.
Gilead selected its partners based on rigorous criteria, given the challenges of manufacturing a complex medicine like lenacapavir. All six partners have successfully collaborated with Gilead to produce high-quality generic versions of medicines for HIV or other infectious diseases and are well equipped to produce sterile injectable medicines. In selecting the licensees, Gilead listened to global health advocates and organizations that advised partnering with manufacturers from multiple countries and continents.
Gilead Prioritizing Registration in 18 Countries with High Incidence to Provide Lenacapavir Until Generic Versions are Available
The licensees announced today will build manufacturing capacity for lenacapavir as quickly as possible, but this process will take time. To provide Gilead-supplied lenacapavir until generic versions are available, Gilead is prioritizing registration in 18 countries that represent about
Gilead to Begin Regulatory Filings for Lenacapavir for PrEP by the End of 2024
Earlier this year, two pivotal Phase 3 trials of lenacapavir for PrEP, PURPOSE 1 and PURPOSE 2, were both unblinded early because they met their key efficacy endpoints of superiority of twice-yearly lenacapavir to once-daily oral Truvada® and background HIV incidence. PURPOSE 1 enrolled cisgender women in
Based on data from these trials, Gilead will begin a series of global regulatory filings by the end of 2024. For high-incidence, resource-limited countries, Gilead is exploring frameworks such as the European Medicines Agency’s EU Medicines for All with the aim of expediting both national regulatory procedures and the attainment of WHO prequalification. Updates on regulatory filings for lenacapavir for PrEP will be shared as discussions with regulatory bodies progress.
Extensive Consultations with HIV Community
Gilead’s strategy to enable broad access to lenacapavir for PrEP reflects input from more than 100 global health stakeholders. Through these discussions, four essential priorities have consistently emerged: delivering long-acting PrEP with speed, at sufficient volume to meet demand, at prices that enable widespread availability and in coordination with partners on the ground. These priorities are guiding every step of Gilead's strategy.
The agreements also build upon Gilead’s two decades of innovation and leadership in global access to medicines. Gilead's partnerships with generic drug manufacturers have helped enable millions of people to benefit from high-quality, low-cost therapies for HIV, viral hepatitis and COVID-19. More than 30 million treatments for HIV, HBV, HCV and COVID-19 have been made available in low- and middle-income countries as a result of partnerships with generic licensees, governments and NGOs.
The use of lenacapavir for the prevention of HIV is investigational, is not approved anywhere globally, and the safety and efficacy for this use have not been established.
There is currently no cure for HIV or AIDS.
About the PURPOSE Program
Gilead’s landmark PURPOSE program is the most comprehensive and diverse HIV prevention trial program ever conducted. The program comprises five HIV prevention trials around the world that are focused on innovation in science, trial design, community engagement and health equity.
The PURPOSE trials are evaluating the safety and efficacy of an investigational, twice-yearly injectable medicine, lenacapavir, to reduce the chance of getting HIV. The Phase 2 and 3 program, consisting of PURPOSE 1-5, is assessing the potential of lenacapavir to help a diverse range of people around the world who could benefit from PrEP.
More information about the PURPOSE program, including individual trial descriptions, populations and locations, can be found at www.purposestudies.com.
About Lenacapavir
Lenacapavir is approved in multiple countries for the treatment of adults with multi-drug resistant HIV in combination with other antiretrovirals. The use of lenacapavir for HIV prevention is investigational and the safety and efficacy of lenacapavir for this use have not been established.
The multi-stage mechanism of action of lenacapavir is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance exhibited in vitro to other existing drug classes.
Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead's HIV prevention and treatment research program. Lenacapavir is being developed as a foundation for potential future HIV therapies with the goal of offering both long-acting oral and injectable options with several dosing frequencies, in combination or as a mono agent, that help address individual needs and preferences of people and communities affected by HIV.
About Gilead HIV
For more than 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 12 HIV medications, including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV treatment medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people.
Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships , collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere. Gilead was recognized as one of the leading philanthropic funders of HIV-related programs in a report released by Funders Concerned About AIDS.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress and complete clinical trials in the anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials, including those involving lenacapavir (such as the PURPOSE 1 trials); uncertainties relating to regulatory applications and related filing and approval timelines, including regulatory applications for lenacapavir for PrEP, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of lenacapavir for indications currently under evaluation and, as a result, lenacapavir may never be successfully commercialized for such indications; Gilead’s ability to effectively manage the supply and distribution of lenacapavir, including through direct supply as well as indirect supply through the voluntary licensing agreements, and the ability of the parties to meet potential demand for lenacapavir, in each case, subject to necessary regulatory approvals; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, as filed with the
Gilead and the Gilead logo, Truvada, and Truvada for PrEP are registered trademarks of Gilead Sciences, Inc., or its related companies.
For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).
View source version on businesswire.com: https://www.businesswire.com/news/home/20241001289353/en/
Ashleigh Koss, Media
public_affairs@gilead.com
Jacquie Ross, Investors
investor_relations@gilead.com
Source: Gilead Sciences, Inc.
FAQ
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