By Etienne Mainimo Mengnjo
EVA Pharma and Gilead have signed a non-exclusive, royalty-free voluntary licensing agreement to increase access to Lenacapavir in 120 countries with high Human Immunodeficiency Virus (HIV) incidence and limited resources.
The agreement was signed on October 4 in Cairo, Egypt. It will enable EVA Pharma to submit its high-quality generic Lenacapavir to multiple regulatory authorities to support demand and broaden accessibility across many countries.
“The urgency of NOW 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.
Armanious added, “To this commitment, we stand our ground as the sole licensee in 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.”
Amgad Talaat, Strategic Alliances Director at EVA Pharma, stressed that EVA Pharma has been committed to the fight against HIV since 2003, consistently empowering governments and healthcare systems to support patient care across Africa.
“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 combating 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,” he said.
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 percent 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, the Philippines, Rwanda, South Africa, Tanzania, Thailand, Uganda, Vietnam, Zambia, and Zimbabwe.
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 the individual needs and preferences of people and communities affected by HIV.
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