Even though pharmacy benefit manager (PBM) reforms were dropped from the continuing resolution that was signed into law Dec. 21 to keep the U.S. government fully functional through March 14, the incoming administration and Congress likely will continue to try to rein in the PBMs, which serve as middlemen in the nation’s drug supply chain.
One topic at the 31st Conference on Retroviruses and Opportunistic Infections (CROI 2024) held in Denver this month was that resistance to antiretroviral therapy (ART) has become a public health problem for people living with HIV. Without a vaccine or a cure, these patients depend on treatments that suppress viremia by preventing the virus from replicating. They are lifelong treatments and, until new advances succeed in eradicating the virus from reservoirs, the only option available.
The U.S. government’s attempts to enforce its ownership of biopharma intellectual property got a setback May 9 when a six-member federal jury in Delaware determined that Gilead Sciences Inc. did not infringe government patents claiming pre-exposure prophylaxis (PrEP) use of Gilead’s HIV drugs, Truvada and Descovy, both of which combine emtricitabine and tenofovir.
Gilead Sciences Inc. is making a one-time $1.25 billion payment, with a commitment for a royalty that analysts predict could add as much $1.5 billion more, to Viiv Healthcare Ltd., in a deal designed to resolve all global pending or potential patent infringement claims relating to sales of HIV drug Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide). The initial payment, recorded in the fourth quarter of 2021, put a significant dent in Gilead’s earnings per share but removes the uncertainty of a trial outcome and clears the way for future bictegravir-containing products.
Modest revenue growth and a 2020 outlook that left analysts uninspired about its near-term prospects pushed Gilead Sciences Inc. shares (NASDAQ:GILD) down about 2% to close Feb. 5 at $65.87, despite growing sales of its HIV medicine, Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide), and what CEO Daniel O'Day called "a sense of urgency" around further business development.
Gilead Sciences Inc.'s third-quarter earnings, though deemed satisfactory, brought lukewarm responses from Wall Street, with analysts such as J.P. Morgan's Cory Kasimov writing in a report that "these days the company's quarterly progress seems to take a back seat to how they [will] ultimately deploy their substantial amount of capital. The Galapagos deal notwithstanding, this feels like a long wait that's quite frankly getting a bit stale." Still reverberating is the arrangement this summer with Galapagos NV, of Mechelen, Belgium, which signed a 10-year research and development pact with Gilead under which Galapagos is getting $3.95 billion up front in hard cash plus another $1.1 billion in equity, in return for which Gilead will essentially have an option to ex-European rights on everything emanating from the firm's clinical and preclinical pipeline.
HONG KONG – Taiwan's National Health Insurance Administration has added Gilead Sciences Inc.'s Biktarvy (bictegravir + emtricitabine + tenofovir alafenamide), a once-daily single tablet for the treatment of adults with HIV-1, to its list of reimbursed medicines.
