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FDA OK for HIV pill Quad sets up showdown over Gilead's price

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The FDA handed Gilead Sciences ($GILD) an approval for its four-in-one HIV drug Quad, extending its blockbuster franchise with a new drug that is expected to find a quick uptake among patients. A spokesperson for Gilead confirmed to FierceBiotech that the "wholesale acquisition cost" for Quad will be $28,500 a year, setting up a potential showdown with payers and patients over the price.

The feds' approval gives Gilead a new product--now dubbed Stribild, pronounced STRY-build--that will push well past the patent expiration on Viread and can be an alternative to Atripla. It's also expected to steal some of Merck's ($MRK) revenue flowing from Isentress. Quad combines the experimental integrase inhibitor elvitegravir and a boosting agent-cobicistat--with Truvada, which combines the older drugs Emtriva and Viread.The once-a-day pill is approved to treat HIV-1 infection in adults who have never been treated for HIV infection.

"Through continued research and drug development, treatment for those infected with HIV has evolved from multi-pill regimens to single-pill regimens," said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research. "New combination HIV drugs like Stribild help simplify treatment regimens."

They also add some serious new revenue. Barclays' C. Anthony Butler--one of a number of careful students of the drug who predicted approval--has estimated peak annual sales at $2.3 billion. That's on the high side, though.Other analysts have estimated peak sales in the hundreds of millions, a sign of just how hard it is to gauge the potential of these therapeutics.

The revenue, though, won't come without controversy. A lineup of public officials already voiced its concerns at a projected price tag of up to $34,000 a year, noting that the figure would overwhelm efforts by state programs designed to help people without insurance. Gilead's projected wholesale price won't win many friends, either. Even at the low end of the projected price, $27,000, Quad would prove destabilizing, critics argue. And this is a patient population that has been quick to organize resistance against anything that it sees as price gouging.

On the other hand, Gilead has been playing this game for years and is an old hand at dealing with critics.

- here's the press release from the FDA
- here's the release from Gilead

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