HQ Team
October 3, 2024: Gilead Sciences, Inc. has signed non-exclusive, royalty-free voluntary licensing agreements with six pharmaceutical makers to make and sell its generic lenacapavir drug for the prevention of HIV.
The pacts were signed in advance of any global regulatory submissions to enable these countries to quickly introduce generic versions of lenacapavir if approved, according to a company statement.
Gilead expects to sell its drug to 120 high-incidence, resource-limited nations. Lenacapavir is currently under end-stage trials for preventing HIV.
“The agreements advance Gilead’s strategy to enable broad, sustainable access to lenacapavir for pre-exposure prophylaxis (PrEP) globally if it is approved, and aligns with Gilead’s vision of ending the HIV epidemic for everyone, everywhere,” according to the statement.
‘Quickly and broadly as possible’
Gilead will support low-cost access to the drug through a two-part strategy. First, it would establish a robust voluntary licensing program, and plan to provide Gilead-supplied products at no profit to the companies until generic manufacturers can fully support demand.
Secondly, the agreements cover lenacapavir for HIV prevention (pending approval) and lenacapavir for HIV treatment in heavily treatment-experienced adults with multi-drug resistant HIV.
“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 Chief Executive Officer 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 Laboratories Limited, Emcure, Eva Pharma, Ferozsons Laboratories Limited, Hetero and Mylan, a subsidiary of Viatris.
‘Process takes time’
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, according to the company statement.
“The licensees announced today 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.
Combination drug
Earlier this year, two pivotal end-stage trials of lenacapavir for PrEP, met their key efficacy endpoints of superiority of twice-yearly lenacapavir to once-daily oral Truvada and background HIV incidence.
Based on data from these trials, Gilead will begin a series of global regulatory filings by the end of 2024.
Lenacapavir (brand name, Sunlenca) was approved by the U.S. Food and Drug Administration for the treatment of HIV infection in adults for whom other HIV medicines have not worked and who meet certain requirements, as determined by a healthcare provider.
Lenacapavir is always used in combination with other HIV medicines.
