Gilead gains next-gen HIV approval from FDA as it looks to beat back competition

Gilead's Norbert Bischofberger

Gilead Sciences ($GILD) has notched yet another HIV therapy approval as touted blockbuster Descovy gains the nod from the U.S. regulator.

The drug's mechanism of action is through emtricitabine/tenofovir alafenamide (TAF), a targeted and souped-up version of tenofovir that can give the similar antiviral activity as Gilead's older HIV drug, the TDF treatment Viread.

But Gilead said its new drug can be given at lower doses than Viread as TAF enters HIV-infected cells more efficiently than TDF. The firm also said in a statement that there is around 90% less of the main ingredient in the bloodstream, potentially reducing AEs.

This comes just one month after the firm won FDA approval for another of it combo treatments for HIV, Odefsey--a single-tablet combination of emtricitabine, approved as Emtriva, which also uses TAF. Both new drugs are expected to reach blockbuster sales, according to analysts, with Thomson Reuters estimating $2 billion in peak revenue for Descovy.

In November, Gilead was also boosted by an FDA approval for another combination tablet designed to keep HIV from replicating itself, Genvoya, which combines Emtriva; cobicistat, cleared as Tybost; elvitegravir, on the market as Vitekta; and tenofovir alafenamide.

Norbert Bischofberger, executive VP of research and development and CSO at Gilead, said: "Descovy represents an important evolution in HIV care. As part of a single tablet regimen or partnered with a third agent, the components of Descovy offer patients a simple and effective combination with a safety profile that has the potential to improve health.

"With [this] approval, Gilead is now able to offer patients and providers in the U.S. a range of options from our TAF based-portfolio, which is designed to help address the diverse needs of HIV patients worldwide."

Despite a host of new meds in this space, Gilead is still facing mounting competition from its drug partner J&J ($JNJ) and the joint venture ViiV Healthcare, which is owned by GlaxoSmithKline ($GSK), Pfizer ($PFE) and Shionogi. Each is at work on combination therapies designed to tamp down HIV with fewer safety risks as they gun for the lion's share of a multibillion-dollar market.

ViiV presents perhaps the biggest challenge to Gilead, cutting into the company's market share with a combo of its own drug called Triumeq.

But Gilead is not just relying on its antiviral portfolio; after a difficult few months with its oncology pipeline, the Harvoni producer this week pledged up to $1.2 billion to acquire the Phase I NASH drug from Nimbus Therapeutics, a Bill Gates-backed drug discoverer based in Cambridge, MA.

NASH, or nonalcoholic steatohepatitis, is a major new area for Big Pharma as companies look to gain access to new therapies for the disease--which is rising each year as both obesity and diabetes rates climb--in what some analysts believe could be a major multibillion-dollar market.

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