GILD Grants Right for HIV PrEP Candidate to Six Generic Companies
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Gilead Sciences GILD has entered into licensing deals with six pharmaceutical companies to manufacture and supply a cheaper version of its investigational drug, lenacapavir, for HIV prevention, also called pre-exposure prophylaxis (PrEP). These companies will market the low-cost versions of lenacapavir, if approved, in 120 primarily low-and-lower-middle-income countries.
The companies chosen to manufacture and supply lenacapavir to 120 countries are Dr. Reddy’s Laboratories, Emcure, Eva Pharma, Ferozsons Laboratories, Hetero, and Mylan (a Viatris subsidiary).
While lenacapavir is not yet approved for use anywhere and its safety and efficacy are still unproven, Gilead believes the drug has the potential to be transformative for HIV prevention, where there is a significant unmet need. Currently, no cure exists for HIV or AIDS.
Earlier this year, Gilead reported that two pivotal late-stage studies, PURPOSE 1 and PURPOSE 2, evaluating the safety and efficacy of lenacapavir to reduce the chance of getting HIV, achieved their primary efficacy goals. Per the data readout, it was observed that the candidate, administered twice a year, demonstrated superior efficacy over the once-daily oral dose of Truvada and background HIV incidence.
Using data from these studies, Gilead plans to submit global regulatory filings by the end of 2024. Year to date, shares of GILD have gained 4.6% against the industry’s 1.5% decline.
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GILD’s Voluntary Licensing Agreement for Lenacapavir
Gilead plans to support low-cost access in high-incidence, resource-limited countries through a two-pronged approach – establishing a strong, royalty-free, voluntary licensing program and providing lenacapavir at no profit until generic manufacturers can meet demand. The agreements cover lenacapavir for both HIV prevention (pending approval) and for treatment in heavily treatment-experienced adults with multi-drug-resistant HIV.
Gilead selected these partners based on strict criteria due to the complexities of producing lenacapavir. All six companies have previously worked with Gilead to produce high-quality generics for HIV and other infectious diseases, and they are experienced in making sterile injectable medicines. Gilead also considered advice from global health advocates, opting for manufacturers from various countries and continents.
On the other hand, the licensees will work to build manufacturing capacity for lenacapavir rapidly. However, this will take time.
Therefore, until generic versions are available, Gilead will supply lenacapavir directly and is focusing on registering the candidate in 18 countries that account for about 70% of the HIV burden in the licensed regions. These countries, chosen in consultation with external partners, include Botswana, Eswatini, Ethiopia, Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, the Philippines, Rwanda, South Africa, Tanzania, Thailand, Uganda, Vietnam, Zambia, and Zimbabwe.