Six drugmakers have inked voluntary licensing (VL) agreements with Gilead Sciences to manufacture and distribute generic lenacapavir, a long-acting injectable HIV drug from the American drugmaker.
The companies that signed the VL agreement included India’s Dr Reddy’s Laboratories, Emcure and Hetero, besides Eva Pharma (Egypt), Ferozsons Laboratories Ltd (Pakistan) and Mylan (a subsidiary of US-based Viatris).
In India, though, the pact comes even as civil society group Sankalp Rehabilitation Trust opposes Gilead’s patent application at the Indian Patent Office (IPO) on the grounds that it was a known compound. The patent opposition case is expected to be heard later this month.
“Gilead has filed numerous patent applications for lenacapavir with the intention to prolong its monopoly beyond the typical 20-year patent term, a practice known as “patent evergreening”, a note from Third World Network said. “The Indian Patents Act does not grant monopolies on established science, such as the salt forms of lenacapavir, which do not make a significant contribution to technological advancement”, said TWN senior researcher KM Gopakumar. Gilead is facing opposition from patient groups and civil society movements across India, Argentina, Indonesia, Thailand, and Vietnam, they pointed out.
The twice-a-year injectable has generated significant global interest, as recent trial results showed superior efficacy as a preventive measure – fuelling hope of an endgame on AIDS. Its pricing at over $40,000, per person, per year, posed a challenge, health activists had pointed out.
Global agreement
On the global agreement, Gilead said, the non-exclusive, royalty-free pact would allow the licensees to supply the breakthrough drug, following regulatory approvals, in 120 high-incidence, resource-limited countries, which are low- and lower-middle income countries (LMIC). The agreements were signed ahead of global regulatory submissions “to enable these countries to quickly introduce generic versions of lenacapavir for HIV prevention, if approved,” it added.
“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, Gilead said. The use of lenacapavir for HIV prevention is investigational, not approved anywhere globally, and the safety and efficacy for this use have not been established, it clarified.
Raising multiple concerns on the agreement, TWN pointed out, that it included “draconian anti-diversion clauses” that prohibited licensees from supplying the product to countries not covered by the license, even for compassionate use or when a country has issued a compulsory license to import generics.
Licensee partners
Daniel O’Day, Gilead Chairman and Chief Executive Officer said in a statement that their 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 (pre-exposure prophylaxis) is approved.”
Gilead intended to begin regulatory filings for Lenacapavir for PrEP by end-2024, it said.
Further, the licensees would build manufacturing capacities for lenacapavir, though this would take time. Till generic versions are available, Gilead said, it was prioritising registration of its product in 18 countries that represented about 70 per cent of the HIV burden in the countries named in the license. These included Botswana, Eswatini, Ethiopia, Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, Philippines, Rwanda, South Africa, Tanzania, Thailand, Uganda, Vietnam, Zambia and Zimbabwe.