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Gilead gets a blockbuster boost from an FDA OK of HIV triplet Biktarvy — and rival GSK fires back

Under the gun as analysts watch the mountain of cash garnered from its hep C franchise melt away, Gilead $GILD got some good news today with the FDA’s approval of its big triplet for HIV. And their rivals at GlaxoSmithKline swiftly retaliated, filing a federal lawsuit in the US accusing Gilead of infringing on its HIV patents.

Known as BIC/F/TAF in the trade, combining the novel bictegravir with the backbone combination of emtricitabine/tenofovir alafenamide into a single daily pill, the FDA noted its approval in the record books. And it will replace a regimen that once required a multitude of pills to keep the virus under control.

Gilead will call this new oral therapy Biktarvy, and the consensus on peak sales is right at $6 billion a year, making it one of the biggest drugs in the industry’s pipeline. And not everyone is satisfied that Gilead will top out there. Leerink’s Geoffrey Porges is all in on a mega success story.

We currently forecast $1bn of sales for Biktarvy during 2018, which is mostly in the US given the timing of EU approval. Our long-term forecast is for Biktarvy to reach global sales of $10bn by 2025 and this is considerably above recent consensus estimates of $6.1bn.

Some of that money, of course, will be cannibalized out of existing sales at Gilead, but the HIV franchise remains a big and growing part of the company as it tackles its new work with Kite on CAR-T.

Gilead faces some major league competition from GlaxoSmithKline’s HIV unit ViiV, which wrestled an early approval for their single pill regimen Juluca last November. It sells for $2,579 a month, leading some analysts to speculate that they could put pressure on Gilead’s pricing, which has yet to be revealed. GSK is also expected to reap about $5 billion in annual sales from its rival therapy.

Almost immediately, GSK — which is facing painful generic competition for Advair — responded to the news of the FDA OK Wednesday afternoon by filing a patent infringement suit against Gilead in federal court. From their statement:

ViiV Healthcare will seek to prove that Gilead Sciences Inc’s triple combination HIV drug containing the HIV integrase inhibitor bictegravir infringes ViiV Healthcare’s patent covering ViiV Healthcare’s dolutegravir and many other compounds that include dolutegravir’s unique chemical scaffold…. ViiV Healthcare will … seek financial redress for patent infringement.

R&D chief Norbert Bischofberger noted during the company’s Q4 call yesterday that the PDUFA date for the triplet was set for February 12, and this company is primed and ready to roll on the commercial front. He said:

BIC/FTC/TAF met its primary objective of non-inferiority at 48 weeks across all four studies and no participants failed BIC/F/TAF for treatment-emergent virological resistance. Additional clinical trials of BIC/F/TAF are ongoing, including a dedicated study in women as well as a study in adolescents living with HIV. We plan to present data from these studies at scientific conferences in 2018.


Image: Gilead CEO John Milligan Bloomberg via Getty Images


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