GlaxoSmithKline and Gilead Sciences have been duking it out in the HIV arena for years, hoping to get an edge over one another with new launches and head-to-head drug trials. Now, in a Tuesday settlement, the companies are resolving a legal dispute over lucrative patents related to GSK’s HIV drug dolutegravir.
Under the settlement, Gilead will make a $1.25 billion payment to GlaxoSmithKline’s ViiV Healthcare unit in the first quarter of 2022. In addition, the company will pay a 3% royalty on U.S. sales of the big-selling HIV drug Biktarvy until a GSK patent expires in October 2027. The drug generated $7.26 billion last year.
In a note to clients, Jefferies analyst Peter Welford said the deal provides “welcome upside” for GSK as it prepares for its consumer healthcare split. The analyst cited “back-of-the-envelope” math to suggest Biktarvy will generate about $50 billion in the U.S. from February 2022 to October 2027. That means the royalty portion of the deal is worth about £1.45 billion ($1.97 billion) at present, the analyst wrote.
In the patent dispute, ViiV Healthcare—plus its shareholders GSK and Shionogi—alleged that Gilead’s Biktarvy infringed their patents related to dolutegravir. Gilead’s drug is a combination of bictegravir, tenofovir alafenamide and emtricitabine.
Thanks to the settlement, Gilead will have a global license to certain patents related to the ViiV drug. ViiV and its shareholders have agreed to not enforce patents “in connection with any past or future claims of infringement relating to Biktarvy” or on any products containing bictegravir.
Earlier in the proceedings, Gilead fell short in motions for dismissal and summary judgment. The case was set to go to trial in January, but that was delayed until May thanks to omicron.
The deal comes as the companies vie for dominance in the HIV market. In fourth-quarter results released Tuesday, Gilead said its HIV sales slipped 4% last year to $16.3 billion. That was expected thanks to the loss of exclusivity for Truvada and Atripla in the U.S., Gilead said. Still, the company is noticing “improved treatment and PrEP medication demand.”
GSK, meanwhile, is underway with the launch of its long-acting HIV drug, Cabenuva, and its long-acting prep option, Apretude.
by Eric Sagonowsky
Source: fiercepharma.com
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