Can Biktarvy Beat Back GSK’s Two-Drug HIV Combo?

Almost as important as being the next potential blockbuster Biktarvy could help beat back a potential threat from GlaxoSmithKline’s (GSK). In 2017 I alerted investors to a two-drug combo from Johnson & Johnson (JNJ) and Glaxo’s HIV unit, ViiV Healthcare:

Glaxo wants to develop HIV therapies that meet that need. It believes the potency, safety and resistance barrier of dolutegravir and the efficacy, safety and tolerability of Johnson & Johnson’s (NYSE:JNJ) rilpivirine make them ideal for a two-drug regimen.

A two-drug combo had the potential to measure up to three- and four-drug combos on efficacy with fewer side effects. I thought it could pose a challenge to Gildead’s entire HIV franchise. ViiV’s Juluca received FDA approval in Q4 2017, becoming the first complete treatment regimen containing only two drugs to treat HIV. Juluca could have punished Gilead’s HIV franchise. However, Biktarvy’s might beat back the Juluca threat:

Biktarvy has a bit of an advantage in the market duel: It’s approved for adults who haven’t had antiretroviral treatment at all or for those who have been virologically suppressed on an antiretroviral regimen for at least three months. Juluca’s approved for adults who’ve been virologically suppressed for six months, with no history of treatment failure—but not for patients who’ve never taken antiretroviral meds.

The fact that Biktarvy is indicated for a larger pool of infecteds appears to provide certain advantages over Juluca. Now the question is whether Biktarvy will threaten Glaxo’s HIV franchise, including Triumeq and Tivicay. Glaxo is suing Gilead for patent infringement pursuant to Biktarvy:

In its lawsuit, GSK claims that it developed a novel chemical “scaffolding” that’s key to the way this new generation of drugs works, and that it’s covered by the company’s ‘385 patent. Gilead’s R&D department knew of the patent and the journal coverage of it, and copied the structure in developing bictegravir, the complaint alleges.

Glaxo is asking for a jury trial and damages, but stopped short of attempting to block Biktarvy’s launch.

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