Foster City, Calif. – October 2, 2024 – Gilead Sciences, Inc. (Nasdaq: GILD) today 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 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.
Read the full press release here.
SEE ALSO:
- UNAIDS response to Gilead’s announcement on signing voluntary licensing agreements on lenacapavir with six generic manufacturers
- Unitaid ready to invest immediately to support accelerated global access to lenacapavir
- IAS statement: IAS calls for global access as Gilead announces lenacapavir licensing
- AVAC calls on Gilead and global stakeholders to accelerate access to generic lenacapavir following license agreements
- People’s Medicines Alliance: Gilead’s lenacapavir plans “abandoning” many middle-income countries
- Health Policy Watch: Gilead urged to expand voluntary licences for its breakthrough HIV treatment
Source : Gilead Sciences, Inc.
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