Drug Development

Gilead racing to FDA with a new HIV cocktail boasting megablockbuster potential

Gilead’s R&D team brought home a clean sweep for its four Phase III studies adding the experimental drug bictegravir to its backbone HIV therapy.

Their cocktail therapy adding bictegravir to its mainstays emtricitabine/tenofovir alafenamide (200/25mg) (FTC/TAF) proved non-inferior to dolutegravir and other antiretroviral therapies in the 4 late-stage studies, setting up a new drug application in a matter of weeks as Gilead races to a near-term marketing OK.

That’s a clear win for Gilead, according to some of the analysts who have been watching this late-stage program advance at a rapid pace. Gilead is a dominant player in HIV, and bictegravir is seen as a key piece in its megablockbuster market puzzle for maintaining its edge against a vibrant ViiV, majority-owned by GSK.

Some GSK investors, though, had been jittery that Gilead’s late-stage data would reflect superior results over dolutegravir (Tivicay). So when the data came in as non-inferior, GSK backers let out a sigh of relief and drove up the pharma giant’s shares 2.25% Tuesday morning.

Gilead’s stock $GILD barely edged up on the news, which met minimum expectations.

Geoffrey Porges

Leerink’s bullish Geoffrey Porges expects the big biotech, in bad need of some positive R&D developments after a string of setbacks last year, will use a priority review voucher to hustle this drug to a quick decision at the FDA, which he now expects to arrive before the end of 2017.

Our forecast for bictegravir starts later than this implied timeline (Q3 2018) but ramps to more than $10bn in global sales based on the product’s convenience, safety and tolerability and efficacy. This disclosure appears to be consistent with that potential, and with the $12-13/share in value contributed by bictegravir in our current company model and valuation.

Added Barclay’s Geoff Meacham:

Bictegravir together with TAF (a nucleotide reverse transcriptase inhibitor) are key drivers of Gilead’s strategy to protect its HIV franchise against the headwinds of the upcoming TDF patent expiry and competition from dolutegravir, ViiV’s new integrase inhibitor.

Norbert Bischofberger

“This investigational single tablet regimen brings together the potency of an integrase inhibitor, bictegravir, with the demonstrated efficacy and safety profile of the FTC/TAF backbone,” said Norbert Bischofberger, executive vice president, research and development and chief scientific officer, Gilead Sciences. “Based on the results from these Phase 3 studies, the combination of bictegravir and FTC/TAF could represent an important advance in triple-therapy treatment for a broad range of HIV patients, and we look forward to submitting regulatory applications in the U.S. and EU this year.”


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