Hetero Signs Voluntary Licensing Agreement with Gilead to Transform Global HIV response, Expanding Access to Groundbreaking Lenacapavir to 120 high-incidence countries

Rhea-AI Summary

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.

Positive

• 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

Negative

• Lenacapavir is not yet approved globally for HIV prevention use

Insights

Pharmaceutical Industry Analyst

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.

Global Health Policy Expert

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

HYDERABAD, India, Oct. 2, 2024 /PRNewswire/ -- Hetero, India's leading pharmaceutical company with the widest global reach, today announced a new partnership with Gilead Sciences Ireland UC (Gilead Sciences, (Nasdaq: GILD)), a non-exclusive, royalty-free voluntary licensing agreement to manufacture and distribute lenacapavir in 120 primarily low- and lower- middle income countries (LMICs). This agreement will broaden access to lenacapavir, the innovative HIV treatment used in combination with other antiretrovirals and will support efforts to prevent HIV through pre-exposure prophylaxis (PrEP).

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 40%* of the global HIV/AIDS population, we take immense pride in the positive impact our efforts have made so far. We will further bring quick access to lenacapavir in Africa, India and other LMICs, where we've been a cornerstone of HIV/AIDS care."

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 96% compared to the background HIV incidence. This highlights the transformative potential of lenacapavir as a long-acting treatment and prevention option.¹

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 U.S. FDA approval in December 2022. The use of lenacapavir for the prevention of HIV is investigational and is not approved anywhere globally.

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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SOURCE Hetero

FAQ

What is the purpose of the licensing agreement between Hetero and Gilead (GILD)?

The agreement allows Hetero to manufacture and distribute lenacapavir, an innovative HIV treatment and prevention drug, in 120 primarily low- and lower-middle income countries, expanding access to this groundbreaking medication.

How effective is lenacapavir in preventing HIV infections?

According to recent clinical trials, lenacapavir reduced HIV infections by 96% compared to the background HIV incidence, demonstrating its high efficacy as a prevention option.

How often does lenacapavir need to be administered for HIV treatment?

Lenacapavir can be administered every six months via a subcutaneous injection, following an initial oral loading dose, making it a long-acting treatment option.

Is lenacapavir approved for HIV prevention globally?

No, the use of lenacapavir for HIV prevention is still investigational and not approved globally. It is currently approved for treatment of multi-drug resistant HIV in the EU and US.