Gilead's latest HIV cocktail wins FDA approval with a blockbuster pedigree

Gilead CEO John Martin

Gilead Sciences ($GILD) won FDA approval for another combination treatment for HIV, building around a cornerstone antiviral therapy as it works to expand its dominance in the field.

The latest drug, Odefsey, is a single-tablet combination of emtricitabine, approved as Emtriva; rilpivirine, marketed by Johnson & Johnson ($JNJ) as Edurant; and tenofovir alafenamide, or TAF, which is a souped-up version of the active ingredient in the company's Viread. The cocktail is approved to treat HIV type 1, the most common form of the virus, in patients 12 and older.

Gilead's combo has the potential to reach peak sales of $1.6 billion by 2020, according to Thomson Reuters. Odefsey's approval marks the second TAF-based regimen to pass FDA muster, following the November clearance of Genvoya, a four-drug cocktail that includes Tybost, Emtriva and Vitekta.

Gilead took advantage of an FDA shortcut to speed Odefsey's path to market, redeeming a priority review voucher that cut the combo's review time from 10 months to 6 months. Gilead paid Knight Therapeutics $125 million for the coupon in 2014.

The company is also developing a single-pill combination of TAF and Emtriva, to which Thomson Reuters affixed a $2 billion peak sales estimate.

Gilead is facing mounting competition from partner J&J and the joint venture ViiV Healthcare, which is owned by GlaxoSmithKline ($GSK), Pfizer ($PFE) and Shionogi. Each is at work on combination therapies designed to tamp down HIV with fewer safety risks, angling for the lion's share of a multibillion-dollar market.

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