Drug Development

Gilead details its case for a new HIV flagship triple, with megablockbuster potential

Gilead $GILD laid out a detailed case for its HIV triple today, journeying to a scientific conference in Paris to present the data from a pair of Phase III studies that demonstrated the combo pill lined up quite nicely alongside GlaxoSmithKline’s dolutegravir.

Adding bictegravir to its backbone HIV drugs emtricitabine/tenofovir alafenamide (200/25mg) (FTC/TAF) produced similar high efficacy results with the GSK rival with a similar safety profile.

Gilead has already laid out its case to the FDA and EMA, looking to convince regulators. Analysts note that this is an odds-on favorite for an approval in both markets, where Gilead is a dominant player.

“These results suggest that the combination of bictegravir with FTC/TAF has the potential to be appropriate for a broad range of HIV patients, including those with mild to moderate renal impairment,” said Paul Sax, the clinical director of the Division of Infectious Diseases at Brigham and Women’s Hospital.

No big surprises here will help Gilead compete against GSK’s ViiV, which has proven to be a major rival in the megablockbuster field. The triple could well be worth billions in annual revenue, analysts speculate, which is particularly important to Gilead as it looks to expand its pipeline following dwindling sales of its hep C franchise drugs, which have proved effective in curing that disease.

EvaluatePharma has pegged 2022 sales of the Gilead triple at $4.4 billion while GSK is expected to rake in $5.4 billion at the same time with its combo.

One of Gilead’s champions, Umer Raffat at Evercore ISI, sees the new drug from Gilead as a core part of its plans to stay dominant in HIV in the 2020s.

“GILD already has an integrase inhibitor on the market (Stribild/Genvoya), but this new integrase inhibitor is expected to have better barrier to resistance (i.e., more competitive vs GSK) + better IP,” notes Raffat. “Data today confirms that GILD’s new integrase inhibitor is generally comparable to GSK’s dolutegrevir as standalone.”


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RAPS Regulatory Convergence 2017