Gilead signs agreements with 6 generic manufacturers for Lenacapavir
Gilead Sciences signed a non-exclusive, royalty-free voluntary licensing agreement with six pharmaceutical manufacturers to make and sell generic Lenacapavir.
The deal is subject to required regulatory approvals, in 120 high-incidence, resource-limited countries, primarily low- and lower-middle-income countries. The agreements were signed in advance of any global regulatory submissions to enable these countries to quickly introduce generic versions of Lenacapavir for HIV prevention if approved.
The agreements advance Gilead’s strategy to enable broad, sustainable access to Lenacapavir for pre-exposure prophylaxis globally if it is approved, and aligns with the company’s vision of ending the HIV epidemic.
Gilead will support low-cost access to the drug in high-incidence, resource-limited countries through a two-part strategy: establishing a robust voluntary licensing program, and planning to provide Gilead-supplied products at no profit until generic manufacturers are able to fully support demand. Additionally, the agreements cover not only Lenacapavir for HIV prevention (pending approval), but also Lenacapavir for HIV treatment in heavily treatment-experienced adults with multi-drug resistant HIV.
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“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,” said Daniel O’Day, chairman and CEO of Gilead. “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.”
The generic companies that will manufacture and supply Lenacapavir to the 120 countries are Dr. Reddy’s, Emcure, Eva Pharma, Ferozsons Laboratories, Hetero and Mylan, a subsidiary of Viatris.
Gilead selected its partners based on rigorous criteria, given the challenges of manufacturing a complex medicine like Lenacapavir. All six partners have successfully collaborated with Gilead to produce high-quality generic versions of medicines for HIV or other infectious diseases and are well equipped to produce sterile injectable medicines. In selecting the licensees, Gilead listened to global health advocates and organizations that advised partnering with manufacturers from multiple countries and continents.
The licensees announced they will build manufacturing capacity for Lenacapavir as quickly as possible, but this process will take time. To provide Gilead-supplied Lenacapavir until generic versions are available, Gilead is prioritizing registration in 18 countries that represent about 70% of the HIV burden in the countries named in the license. These countries, identified in consultation with external partners, are Botswana, Eswatini, Ethiopia, Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, Philippines, Rwanda, South Africa, Tanzania, Thailand, Uganda, Vietnam, Zambia and Zimbabwe.
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Gilead’s strategy to enable broad access to Lenacapavir for PrEP reflects input from more than 100 global health stakeholders. Through these discussions, four essential priorities have consistently emerged: delivering long-acting PrEP with speed, at sufficient volume to meet demand, at prices that enable widespread availability, and in coordination with partners on the ground.
More than 30 million treatments for HIV, HBV, HCV and COVID-19 have been made available in low- and middle-income countries as a result of partnerships with generic licensees, governments and NGOs, the company noted.
The use of Lenacapavir for the prevention of HIV is investigational and is not approved anywhere globally, and the safety and efficacy for this use have not been established.
There is currently no cure for HIV or AIDS.