EVA Pharma signs agreement with Gilead to expand access to HIV treatment

EGYPT—EVA Pharma has signed a nonexclusive, royalty-free voluntary licensing agreement with Gilead Sciences, marking a significant step in the global fight against HIV.

This agreement grants EVA Pharma the right to manufacture and supply generic versions of lenacapavir, both in the form of the active pharmaceutical ingredient (API) and the finished product.

 Lenacapavir is a long-acting HIV treatment aimed at heavily treatment-experienced (HTE) adults with multi-drug-resistant HIV, as well as HIV prevention, pending regulatory approval.

The agreement also includes a crucial technology transfer from Gilead, providing EVA Pharma with the necessary know-how to produce lenacapavir.

This knowledge transfer will enable EVA Pharma to ensure sustainable access to lenacapavir across 120 high-incidence, resource-limited countries, leveraging its local manufacturing capabilities and strong African presence.

Gilead is actively pursuing frameworks such as the European Medicines Agency’s EU Medicines for All, which aims to expedite regulatory processes with the U.S. FDA and secure World Health Organization (WHO) prequalification.

These efforts will allow EVA Pharma to submit its high-quality generic version of lenacapavir for approval by multiple regulatory bodies, ensuring the medicine’s availability to meet global demand and broaden access across the 120 countries covered by the agreement.

In a statement, Riad Armanious, CEO of EVA Pharma, emphasized the urgency of the global AIDS epidemic, citing the 2024 Global AIDS Report titled The Urgency of Now: AIDS at a Crossroads.

Armanious stressed that collective action, from innovative research to ensuring sustainable access to essential medicines, is vital to ending the HIV/AIDS epidemic.

He reaffirmed EVA Pharma’s commitment to being the sole licensee for lenacapavir in Africa and noted that the company is already fast-tracking efforts to fulfill its mission in partnership with Gilead.

Amgad Talaat, Strategic Alliances Director at EVA Pharma, echoed this sentiment, highlighting the company’s long-standing commitment to fighting HIV since 2003.

He noted that EVA Pharma has consistently worked to empower African governments and healthcare systems to improve patient care.

 To ensure sustainable access to HIV treatment, the company has expanded its focus to localizing the production of drug substances.

In collaboration with Gilead, EVA Pharma has been a pioneer in generic voluntary licensing agreements, having played a key role in combating Hepatitis C Virus (HCV) and making remdesivir available for COVID-19 patients.

Talaat also pointed to the significance of this new milestone, with EVA Pharma set to supply lenacapavir across Africa, including South Africa, for the first time.

Of the six generic manufacturers included in Gilead’s voluntary licensing agreement, EVA Pharma is the only local manufacturer in Africa.

Following the successful technology transfer from Gilead, the company expects to complete the manufacturing of lenacapavir API by the end of 2024, which will pave the way for the production of the finished pharmaceutical product.

Within the next 25 months, EVA Pharma plans to begin supplying the African-made lenacapavir.

 In the initial phase, the company will focus on exporting the drug to 18 countries, collectively accounting for around 70% of the HIV burden in the 120 countries covered by the license.

 These countries include Botswana, Eswatini, Ethiopia, Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, the Philippines, Rwanda, South Africa, Tanzania, Thailand, Uganda, Vietnam, Zambia, and Zimbabwe. 

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