Gilead Sciences inks pacts with Dr Reddy's Labs, Emcure, Hetero and 3 others for HIV drug Lenacapavir
Foster City: Gilead Sciences, Inc. has announced that it has signed non-exclusive, royalty-free voluntary licensing agreements with six pharmaceutical manufacturers to make and sell generic lenacapavir, subject to required regulatory approvals, in 120 high-incidence, resource-limited countries, which are primarily low- and lower-middle income countries.
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.
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 (PrEP) globally if it is approved, and align with Gilead’s vision of ending the HIV epidemic for everyone, everywhere. 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 product at no profit to Gilead 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 (HTE) adults with multi-drug resistant HIV,“ the Company stated in a BSE filing.
"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.”
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.
Earlier this year, two pivotal Phase 3 trials of lenacapavir for PrEP, PURPOSE 1 and PURPOSE 2, were both unblinded early because they met their key efficacy endpoints of superiority of twice-yearly lenacapavir to once-daily oral Truvada and background HIV incidence. PURPOSE 1 enrolled cisgender women in South Africa and Uganda, and PURPOSE 2 enrolled cisgender men, transgender men, transgender women and non-binary individuals in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the United States who have sex with partners assigned male at birth.
As per the release, based on data from these trials, Gilead will begin a series of global regulatory filings by the end of 2024. For high-incidence, resource-limited countries, Gilead is exploring frameworks such as the European Medicines Agency’s EU Medicines for All with the aim of expediting both national regulatory procedures and the attainment of WHO prequalification. Updates on regulatory filings for lenacapavir for PrEP will be shared as discussions with regulatory bodies progress.
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