EVA Pharma (www.EVAPharma.com) announced today a non-exclusive, royalty-free voluntary licensing agreement signed with Gilead (https://apo-opa.co/4dB3Nwx), allowing EVA Pharma to manufacture and supply generic lenacapavir in form of active pharmaceutical ingredient and finished pharmaceutical product. This agreement includes the technology transfer of know-how to make and use lenacapavir allowing for sustainable accessibility to lenacapavir in 120 high-incidence, resource-limited countries through EVA Pharma’s local manufacturing capabilities and strong foothold in Africa.

The agreement covers lenacapavir for HIV treatment in heavily treatment-experienced (HTE) adults with multi-drug-resistant HIV, as well as lenacapavir for HIV prevention (pending approval). Gilead is exploring frameworks such as the European Medicines Agency’s EU Medicines for All with the aim of expediting both U.S. FDA procedures and the attainment of WHO prequalification. This will enable EVA Pharma to submit its high-quality generic lenacapavir for multiple regulatory authorities to support demand and broaden accessibility across 120 countries.

“The urgency of NOW (https://apo-opa.co/3zLMw5Q) demands that we go fast and far to end HIV/AIDS. This goal is only reached through collective efforts, from innovation to sustainable access to medicines.” said Riad Armanious, CEO of EVA Pharma. “To this commitment we stand our ground as the sole licensee on Africa, EVA Pharma has already rolled the ball on fast-track actions towards our joint mission with Gilead. Combining Gilead’s expertise and EVA Pharma’s capabilities and reach we ensure that no one is left behind in the fight against HIV.”

“EVA Pharma has been committed to the fight against HIV since 2003, consistently empowering governments and healthcare systems to support patient care across Africa” said Amgad Talaat, Strategic Alliances Director at EVA Pharma. “In our ongoing effort to ensure sustainable access, EVA Pharma has expanded its focus to localizing drug substance production. In collaboration with Gilead we have been setting numerous firsts in the area of generic voluntary licensing, from combatting HCV to making remdesivir available for COVID patients. And now, we embark on another significant milestone by supplying lenacapavir to patients across the continent, including South Africa for the first time”

Of the six generic manufacturers in Gilead’s voluntary licensing agreement, EVA Pharma is the sole local manufacturer in Africa. Responding to the urgency of this shared mission, EVA Pharma expects to complete lenacapavir API manufacturing by the end of 2024, following the completion of the tech-transfer from Gilead, paving the way for the production of lenacapavir finished product. The company expects to begin supplying the high-quality, African-made lenacapavir within 25 months. Leveraging its extensive pan-African reach, EVA Pharma will supply the medicine to 120 countries, with the first phase of export including 18 countries representing the highest incidence rate (about 70% of the HIV burden in the countries named in the license) to receive lenacapavir as quickly as possible. These countries are Botswana, Eswatini, Ethiopia, Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, Philippines, Rwanda, South Africa, Tanzania, Thailand, Uganda, Vietnam, Zambia and Zimbabwe.