Gilead takes a $125M FDA shortcut with its latest HIV combo

Last year, Gilead Sciences ($GILD) paid $125 million for a ticket promising a speedy FDA review. Now the Big Biotech is cashing it in, submitting a combination HIV treatment for approval and lining up for a truncated regulatory process.

Gilead's latest HIV therapy combines its own emtricitabine and tenofovir alafenamide with Johnson & Johnson's ($JNJ) rilpivirine, pooling three antivirals to stop HIV from replicating itself in the body. Emtricitabine is already approved as Emtriva, and rilpivirine is on the market as Edurant, but tenofovir alafenamide, a souped-up version of the active ingredient in Gilead's Viread, remains investigational.

The trio, abbreviated as R/F/TAF, will now go before the FDA. With Gilead's submission, the agency has 60 days to accept the application, after which it will begin its customary review of the combo's clinical data. That process generally takes 10 months, but Gilead's November move to pay $125 million for Knight Therapeutics' priority review voucher will cut that down to 6 months.

The FDA created the voucher program to encourage R&D in tropical and pediatric diseases, giving any company that wins approval in those fields a tradeable coupon for a shortened review. And the value of such vouchers has skyrocketed over the past year.

Sanofi ($SNY) and Regeneron ($REGN) became the first to take advantage of the program, last summer paying $67.5 million for BioMarin's ($BMRN) voucher in order to leapfrog Amgen ($AMGN) in the race to commercialize new cholesterol therapies. Gilead struck its deal to pay twice that a few months later, and, in May, Sanofi agreed to hand over a whopping $245 million to Retrophin ($RTRX) in exchange for the same asset.

R/F/TAF is one of three tenofovir alafenamide-based treatments under FDA review, joining a pill combining the active ingredient with emtricitabine alone and another adding elvitegravir and cobicistat to that pairing. Gilead is developing R/F/TAF under a 2009 partnership with J&J covering a host of HIV treatments.

- read the statement

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