Gilead patent cliff looms as Teva plans generic Truvada launch

Gilead’s HIV blockbuster Truvada looks set to face generic competition in the US next year, a year earlier than expected, putting the bulk of the product’s $3 billion annual sales at risk.

The US company had been predicting the onset of generic competition to Truvada (emtricitabine/ tenofovir disoproxil fumarate or TDF) in 2021, but a recent SEC filing from Gilead suggests Teva – in pole position to bring a copycat version to market – is now able to launch in 2020.

Gilead is already facing competition to Truvada in Europe, where patent protection extended by a supplementary protection certificate (SPC) was overturned last year and generics have already been launched – albeit at risk of damages if Gilead were to win an appeal of the ruling.

Generic competition in the US is a much bigger hit for Gilead, however, as the American market accounted for $2.6 billion of the product’s sales last year. In its filing, Gilead notes that a patent settlement means that Teva will be free to launch generic Truvada and three-drug combination Atripla (emtricitabine/TDF/efavirenz) – which made $1.2 billion last year – from 30 September 2020.

The early arrival puts Gilead under more pressure to accelerate the take-up of its new Descovy (emtricitabine/tenofovir alafenamide or TAF) based regimens, including Biktarvy which adds new integrase inhibitor bictegravir to make a triple therapy.

Gilead’s concession to Teva comes as it has decided to donate 2.4 million bottles of Truvada at no cost to a US-government led prevention programme aimed at ending the HIV epidemic.

The move to make Truvada available for pre-exposure prophylaxis or PrEP – which helps prevent uninfected but high-risk individuals from contracting the disease in combination with safe sex – has been welcomed by HIV campaigners who note that PrEP can reduce the risk for HIV infection by more than 90% when taken consistently.

Uptake has been slow however, largely because of cost, and the free supplies will help address that issue, although Jen Kates, director of global health and HIV policy at the Kaiser Family Foundation (KFF) said that the free supplies would only increase the proportion of people on the drug who need it to around 36% from 18%.

Tweet: https://twitter.com/jenkatesdc/status/1126862724481409025

On the other hand, the donation will restrict the market for generics of the drug, as PrEP accounts for a sizeable chunk of Truvada’s sales.

Gilead has suggested that more than 200,000 people were taking Truvada for PrEP at the end of the first quarter of 2019, out of 1.1 million considered at risk of contracting HIV.

The donation, which lasts until 2030, will transition to Descovy if it is approved for use as PrEP, according to Gilead. Descovy is thought to have some safety advantages over Truvada and has a simpler dosing regimen requiring just one tablet per day, and reported positive PrEP data last month.

Campaign group PREP4ALL said that the deal between Gilead and Teva will “do little to reduce the price in a way that will increase access,” adding that it “remains suspicious of the terms and lack of transparency surrounding the Teva settlement.”

The group adds: “US taxpayers paid for the development of this drug, yet it’s far too expensive for the people who need it most. Gilead currently prices at between $1,600 and $2,000 for a month’s supply of a pill that can be manufactured for a fraction of that amount. We must make sure that everyone who needs it can get it.”