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For years, Gilead Sciences has stated that its antiviral drug Truvada, used to treat and prevent HIV infection, would not be facing generic competition until 2021. But Gilead has recently – and quietly – raised its expectations for generics.
This not only puts Truvada's $ 2.6 billion US sales ahead of schedule, but also gives Gilead less time to convert patients to a newer drug, Descovy, who recently presented positive data as a preventative , or PrEP.
Teva is scheduled to launch its copier in the United States on September 30, Gilead said in its latest quarterly securities report. In February, Gilead stated that Truvada's copies would not be used until 2021, citing a 2014 Teva patent agreement. The last filing quotes the same Teva agreement and a 2020 deployment date.
The generic news follows Descovy's new PrEP data, which Gilead plans to use to expand the list of indications for the drug. When the data was released in March, Geoffrey Porges, an analyst at SVB Leerink, said he "was laying the groundwork for Gilead to actively transfer PrEP's revenue of more than $ 2 billion currently generated by Truvada to Descovy ".
Moreover, investors added, investors would likely expect most of this revenue to accrue to Descovy before Truvada lost its exclusivity in September 2021.
Although patient advocates are satisfied, they are also asking questions, given Gilead's previous revelations. The contract may have an acceleration clause allowing Teva to postpone its launch date upward, but Gilead would not comment on the contract itself.
Gilead's Truvada is increasingly used as a PrEP agent by those at higher risk of contracting the virus, but activists say its high price puts it out of reach for many who would benefit. In a statement, Aaron Lord, a PrEP4All activist and medical doctor at New York University School of Medicine, described the news as "a victory for the LGBTQ + community, for HIV activists and for taxpayers." Americans "but that" this should only be a beginning. "
"Even after their announcement, Gilead has exclusive rights to Truvada as PrEP for an additional 15 months and Teva as the only generic drug manufacturer in the US market," added Lord. "This will not reduce the price in any way that will increase access and PrEP4All remains wary of the conditions and lack of transparency surrounding the Teva regulation."
Gilead's Truvada generated $ 3 billion last year worldwide and is already facing European competition. Sales in the United States have been a major growth factor for the company, as its hepatic C activity is facing increasing competition. In this processing area, where Gilead has already made a fortune, sales have collapsed.
The first news about generics comes as Gilead faces a thorough review of its Truvada PrEP patent. Activists pointed out that the government had funded early research on the use of PrEP for the drug and questioned the legitimacy of Gilead's patent. Last month, the Washington Post announced that the Justice Department was investigating. Also this year, President Donald Trump has proposed PrEP as part of his plan to fight the HIV epidemic in the years to come.
But Gilead says the launch date of the new generics has nothing to do with this review. "This agreement is not related to ongoing discussions with the federal government to determine the best ways to expand the access of vulnerable populations to the Truvada in the United States and to support the federal plan to End the HIV epidemic, "said a spokesman for Gilead at FiercePharma.
In the midst of financial hardship, Gilead chose former Roche executive Dan O'Day this year to take over management. O'Day has experience in the commercialization of successful anti-cancer drugs, prompting many market commentators to believe that his appointment was an indication that Gilead would use oncology for its next phase of growth.
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