Hetero Drugs Ltd.

- 非排他性自愿许可协议促成了lenacapavir的生产和销售，用于预防HIV以及治疗那些经历多种治疗方案且产生多种药物耐药性的HIV患者 印度海得拉巴 2024年10月11日 /美通社/ -- 作为印度领先且在全球业务覆盖最广泛的制药公司，Hetero今日宣布与Gilead Sciences Ireland UC（简称Gilead Sciences，纳斯达克股票代码：GILD）达成新的合作伙伴关系。双方签订了一份非排他性、免版税的自愿许可协议，在120个主要为低收入和中低收入国家/地区（LMIC）生产和分销lenacapavir。 该协议将扩大对lenacapavir的获取渠道，这是一种与其他抗逆转录病毒药物联合使用的创新性HIV治疗药物，并将支持通过暴露前预防（PrEP）来预防HIV。 通过这项合作，我们朝着为经历多种治疗方案且产生多种药物耐药性的HIV患者提供救生治疗方案的目标迈出了重要的一步，同时也为那些医疗资源有限的地区带来了预防HIV的新希望。 Lenacapavir作为一种突破性的HIV-1衣壳抑制剂，可与其他抗逆转录病毒药物联合使用，治疗多重耐药的HIV-1感染。 它独特的作用机制能够针对HIV病毒生命周期的多个阶段，为治疗选择有限的患者提供高效的治疗方案。 提高可负担HIV治疗的普及率 Hetero集团公司董事总经理Vamsi Krishna Bandi博士强调：“与Gilead Sciences的合作增强了我们突破HIV预防和治疗界限的决心。 三十多年以来，Hetero始终站在全球抗击HIV/AIDS的前线，为最需要的地区开创了经济实惠且能挽救生命的治疗方案。 我们提供超过30种组合方案，解决了全球近40%*的HIV/AIDS患者的问题，对于我们迄今为止努力所取得的积极成效，我们感到无比自豪。 我们将在非洲、印度以及其他中低收入国家加快引入lenacapavir，这些地区一直是我们提供HIV/AIDS治疗的核心区域。” 凭借我们在研究领域的强大专注力、无可匹敌的生产规模以及分销方面的专业知识，我们已完全准备好在120个高发病率且资源有限的国家/地区快速扩大lenacapavir的获取渠道。 他补充道，凭借我们的lenacapavir仿制药，我们将把服务扩展至传统覆盖范围之外的社区，确保即便是在最缺乏资源和最偏远的地区，人们同样能够获得他们应享有的高效且经济的HIV预防和治疗。 突破性临床成果 本月早些时候，Gilead公布了一项关键的三期临床试验取得了令人欣喜的结果。 中期分析显示，与背景HIV感染率相比，lenacapavir使HIV感染率降低了96%。 这突显了lenacapavir作为一种长效治疗和预防选择的变革性潜力。 1 此外，在正在进行的临床试验中，对lenacapavir作为长效HIV预防药物的可能性进行研究。 该药物的长效版本，在初次口服负荷剂量后，每六个月可通过皮下注射进行一次给药。 继2022年8月获得欧盟批准后，lenacapavir在同年12月也获得了美国FDA的批准，用于治疗具有多重耐药性的HIV阳性成人患者。 该药物预防HIV的用途还处于研究阶段，尚未在全球任何地方获得批准。 关于Hetero Hetero是一家全球知名的垂直整合制药公司，专注于高品质化学和生物药品的研发、生产和营销，涵盖广泛的治疗领域。 凭借在制药行业30余年的专业知识，Hetero的战略业务遍及活性药物成分（API）、全球仿制药、生物仿制药以及定制制药服务。 该公司是全球最大的活性药物成分 (API) 生产商之一。 如需了解关于Hetero的更多信息，请访问 www.hetero.com。

Gilead will provide the drug at a non-profit margin until generics enter the market. Credit: Tada Images via Shutterstock. Gilead Sciences has announced the signing of voluntary licencing agreements with six generic pharmaceutical manufacturers to facilitate access to lenacapavir, a potential human immunodeficiency virus (HIV) prevention drug, in 120 resource-limited and high-incidence nations. The company signed agreements with Dr. Reddy’s Laboratories, Eva Pharma, Emcure, Ferozsons Laboratories, Mylan, a subsidiary of Viatris , and Hetero. These agreements, which are royalty-free and nonexclusive, will allow the production and sale of generic lenacapavir, pending regulatory approvals. The initiative is part of Gilead’s strategy to ensure broad, sustainable access to lenacapavir globally for preexposure prophylaxis (PrEP), aligning with its goal to end the HIV epidemic. Initially, the drug will be supplied at no profit until generic versions are available, and the agreements also encompasses lenacapavir for HIV treatment in adults with multi-drug resistant HIV. See Also: FDA lifts clinical hold on Avidity’s lead antibody conjugate therapy trial The companies are expected to build manufacturing capacity for lenacapavir. Gilead is prioritising registration in 18 countries, which carry about 70% of the HIV burden within the licensed territories. Gilead chair and CEO Daniel O’Day said: “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. “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.” Two Phase III trials, PURPOSE 1 and PURPOSE 2, evaluated lenacapavir for PrEP, leading to their early unblinding. These trials included diverse populations across several countries. Gilead said it is committed to providing post-trial access to lenacapavir for participants and plans to begin global regulatory filings by the end of 2024. Gilead is also exploring expedited regulatory frameworks, such as the European Medicines Agency’s EU Medicines for All, to hasten the approval process in high-incidence, resource-limited countries. The company will update on the progress of regulatory discussions for lenacapavir as a PrEP method. Lenacapavir is still investigational for HIV prevention and has not yet received approval in any country. In May this year, Cartography Biosciences entered into a strategic partnership with Gilead Sciences, focusing on the discovery and development of new oncology therapies.

iStock, Sundry Photography Gilead Sciences is granting licenses to six companies to produce lenacapavir for pre-exposure prophylaxis, as well as for treating human immunodeficiency virus in heavily pre-treated adults with multidrug-resistant infections. Gilead Sciences on Wednesday announced that it has entered into non-exclusive, royalty free and voluntary licensing deals with developers to manufacture and sell a generic version of its HIV drug lenacapavir in more than 100 resource-limited countries. Under the terms of the agreements, Gilead is granting licenses to six generics developers to produce lenacapavir for pre-exposure prophylaxis (PrEP), as well as for treating HIV in heavily pre-treated adults with multidrug-resistant infections. The six selected partners are Dr. Reddy’s Laboratories, Emcure, Eva Pharma, Ferozsons Laboratories, Hetero and Viatris’ Mylan. Gilead will also provide its products at no profit until its generics partners can fully support demand. The licensing deals will cover 120 low- and middle-income countries where the incidence of HIV is high. The agreements were signed before filing global regulatory applications for lenacapavir “to enable these countries to quickly introduce generic versions” of the drug, according to the company. The deals underscore Gilead’s commitment to make lenacapavir “available as quickly and broadly as possible where the need is greatest,” CEO Daniel O’Day said in a statement, noting that the company has 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.” Lenacapavir is an HIV-1 capsid inhibitor that works by inhibiting various steps of the virus’ life cycle, including the final viral assembly and release into the extracellular space. Unlike other antiviral HIV therapies, lenacapavir targets multiple steps of viral replication. Lenacapavir currently has no documented cross-resistances to other drug classes. Approved under the brand name Sunlenca, lenacapavir won the FDA’s nod in December 2022 as a twice-yearly option treatment for patients with multi-drug-resistant HIV, though its use as PrEP has not yet been cleared. Gilead ran the Phase III PURPOSE program to assess the potential of lenacapavir for HIV prophylaxis. In June 2024, the pharma released data from PURPOSE 1, touting a 100% prevention efficacy in cisgender women . Last month, Gilead followed this up with an interim readout from PURPOSE II, which demonstrated a 96% HIV risk reduction in a broader population including cisgender men, transgender men, transgender women and gender non-binary individuals who have sex with partners assigned male at birth. Gilead is set to start regulatory filings for lenacapavir as PrEP by the end of the year. Wednesday’s licensing deals come as the pharma has faced increasing pressure from various organizations to improve access to its HIV medicine. In July 2024, UNAIDS Executive Director Winnie Byanyima urged Gilead to “move quickly to license lenacapavir to generics producers,” which can “bring the price down and sere all countries where the majority of people who are at risk live.” Byanyima in a statement on Wednesday applauded Gilead, while noting that “much more work is urgently needed to ensure … that Gilead’s commitment to rapid, affordable access is fulfilled.”