For years, Gilead Sciences has said its antiviral drug Truvada, used to treat and prevent HIV infection, wouldn’t face generic competition until 2021. But Gilead recently—and quietly—moved its generic expectations up a year.
That not only puts Truvada's $2.6 billion in U.S. sales on the line earlier than expected, but gives Gilead less time to convert patients over to its newer drug Descovy, which recently put up positive data as a preventative, or PrEP.
Teva is now set to launch its copycat in the U.S. next September 30, Gilead said in its most recent quarterly securities filing. As recently as February, Gilead had been saying Truvada copies wouldn't hit until 2021, citing a 2014 patent deal with Teva. The latest filing cites the same Teva deal and a 2020 rollout date.
The generic news comes on the heels of Descovy's new PrEP data, which Gilead plans to use to expand the drug's list of indications. When the data posted in March, SVB Leerink analyst Geoffrey Porges said it "sets the stage for Gilead to actively transition the more than $2 billion in current PrEP revenue for Truvada to Descovy."
And what's more, Porges said, investors would likely expect most of that revenue haul to head Descovy’s way before Truvada’s September 2021 exclusivity loss.
While patient advocates are happy, they’re also asking questions, given Gilead's previous disclosures. The contract may have had an acceleration clause allowing Teva to move its launch date up but Gilead wouldn't comment on the contract itself.
Gilead’s Truvada has been increasingly used as a PrEP agent by those at an increased risk of contracting the virus, but activists say its high price tag puts it out of reach for many who'd benefit. In a statement, PrEP4All activist Aaron Lord, a physician at the New York University School of Medicine, called the news a "victory for the LGBTQ+ community, for HIV activists and for U.S. taxpayers," but said it "should only be the beginning."
"Even their announcement today leaves Gilead with exclusive rights to Truvada as PrEP for another 15 months and Teva as the only generic manufacturer on the U.S. market," Lord added. "This will do little to reduce the price in a way that will increase access and PrEP4All remains suspicious of the terms and lack of transparency surrounding the Teva settlement."
Gilead’s Truvada generated $3 billion last year worldwide and already faces European competition. Sales in the U.S. have been an important growth contributor for the company as its hep C business faces increasing competition. In that treatment area, where Gilead once made a fortune, sales have crumbled.
The earlier generics news comes as Gilead faces scrutiny on its Truvada PrEP patent. Activists pointed out that the government funded early research on the drug's PrEP use and questioned the legitimacy of Gilead's patent. Last month, the Washington Post reported that the Department of Justice is investigating. Also this year, President Donald Trump proposed PrEP as one part of his plan to combat the HIV epidemic in the coming years.
But Gilead says the new generics launch date has nothing to do with that scrutiny. "This agreement is not related to current discussions with the federal government to determine the best ways to broaden access to Truvada for PrEP for vulnerable populations in the United States and support the federal plan to end the HIV epidemic," a Gilead spokesman told FiercePharma.
Amid its financial struggles, Gilead this year brought in former Roche executive Dan O’Day to serve as its next CEO. O’Day has experience commercializing blockbuster cancer drugs, so many market watchers saw his appointment as an indication Gilead will look to oncology for its next phase of growth.
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