Guarding a $2 billion franchise operation, Gilead hustles up its sNDA for Descovy. But will it work?

Gilead has two years to go as it works to transition patients from Truvada to Descovy before the older drug sees an onslaught of generics slice and dice the market.

But they aren’t wasting a day.

The big biotech said today that they will use a priority review voucher to hustle along the supplemental application to sell the drug to reduce the risk of infection among a vulnerable HIV-negative population. That will cut the review time down from 10 months to 6.

Geoffrey Porges

The news follows a relatively successful Phase III trial comparing the two drugs, which has drawn considerable scrutiny and some doubts as to just how lucrative this may prove in the longterm. The Phase III data announced a month ago were actually just non-inferior, though Gilead made much of the statistically insignificant numerical superiority results for their new brand.

Why? Gilead has a couple of billion dollars in revenue it won’t want to give up to the generics — but it may have to.

Here’s SVB Leerink’s Geoffrey Porges on the Phase III head-to-head:

This result sets the stage for Gilead to actively transition the >$2bn in current PrEP (pre-exposure prophylaxis) revenue for Truvada to Descovy. The differences between Truvada and Descovy remain modest, and it is difficult to tell how much of the transition will stick after the introduction of generic Truvada in 2021. At this stage paying ~$18,000 per year, for a 1% difference in Bone Mineral Density and a 2-4mL/min difference in renal function might challenge the generosity of post-2020 government and private payers, but Gilead has more than two years to establish the case for Descovy.

Jefferies’ Michael Yee, though, has been more supportive, noting small improvements make a big difference over the long, long run patients use HIV meds.

Gilead has long had one of the most aggressive drug development shops in the industry, which explains the PRV use for a supplemental application. 

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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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