GILEAD SCIENCES SL

A new HIV prevention drug, lenacapavir, shows 100% efficacy in clinical trials when injected every six months, with no infections reported among women in Uganda and South Africa. Initial results from a separate trial show 99% protection rates among men who have sex with men, transgender, and non-binary people. Gilead Sciences, the manufacturer, is under pressure to lower the current $42,000 annual treatment price and has signed licensing agreements with generic manufacturers to increase global access.

Gilead Sciences partners with six pharma manufacturers to produce generic lenacapavir for HIV prevention and treatment, aiming to sell in 120 resource-limited countries, addressing HIV advocacy groups' calls for affordability.

A new HIV prevention drug, lenacapavir, shows 100% efficacy in clinical trials when injected every six months, with no infections reported among women participants. Developed by Gilead Sciences, lenacapavir is currently priced at $42,000 per year for treatment but is not yet approved for prevention. Gilead has signed licensing agreements with generic drug manufacturers to produce low-cost versions for 120 countries and plans to seek regulatory approval by 2024.

Gilead Sciences permits six generic companies in Asia and North Africa to produce lenacapavir, a twice-yearly HIV-prevention injection, for 120 countries, including those in sub-Saharan Africa with high HIV rates, at no licensing cost.

Gilead Sciences to make cheaper lenacapavir available in 120 low- and middle-income countries; campaigners criticize exclusion of high HIV burden countries, especially in Latin America; UNAids calls for universal access and transparency on pricing.

Six generic drugmakers, including Dr. Reddy’s, Hetero, and Mylan, signed non-exclusive, royalty-free licensing agreements with Gilead Sciences to manufacture and market generic lenacapavir in 120 high-incidence countries. Lenacapavir, approved for treating multidrug-resistant HIV-1, is under investigation for HIV prevention but not yet globally approved.

The European Commission approves Ipsen's IQIRVO (elafibranor) for primary biliary cholangitis, the first new therapy in the EU in a decade. Other companies, including CymaBay, Zydus, and GlaxoSmithKline, are preparing to enter the market. The approval is based on the Phase III ELATIVE trial, showing a 47% clinical benefit of IQIRVO combined with UDCA. Additionally, Gilead Sciences' LIVDELZI (seladelpar) received FDA accelerated approval for PBC.

Hetero and Dr Reddy’s sign non-exclusive, royalty-free licensing agreement with Gilead Sciences to manufacture and distribute lenacapavir, an HIV treatment drug, in 120 low- and lower-middle-income countries, including India. Lenacapavir, a first-in-class HIV-1 capsid inhibitor, is currently under investigation for HIV prevention. The agreement aims to make the drug accessible at affordable costs, with Indian generic manufacturers potentially producing it for $100 per person per year.

Dr Reddy's Laboratories partners with Gilead Sciences for the manufacture and commercialisation of HIV drug Lenacapavir in India and 120 other countries. The agreement includes technology transfer, bioequivalence/clinical studies, and product registration. Lenacapavir, approved for treatment-experienced adults with multi-drug resistant HIV-1, is also under investigation for HIV prevention (PrEP).