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Should Gilead's quad pill get an exclusivity extension from FDA?

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One of Gilead Sciences' ($GILD) 2012 victories was winning FDA approval for its so-called "Quad" pill for AIDS. Officially dubbed Stribild, the drug puts four HIV fighters into one oral treatment taken once a day.

But as Pharmalot reports, Gilead's ability to cash in on Stribild is limited by FDA exclusivity rules. As a combination of already-approved treatments, the drug automatically qualifies for a monopoly lasting three years. It would be eligible for 5 years, if all four of those active ingredients had been tweaked significantly enough to qualify as "active moieities." Only two of them were.

So, Gilead is asking FDA for that 5 years of exclusivity anyway. It says that Stribild is innovative enough--and beneficial enough to patients--to qualify the company for that extra two years, and the additional financial rewards those two years would bring. If analyst estimates are correct, those two years could amount to billions of dollars.

Gilead argues that combination drugs help patients comply with their treatment. FDA should be encouraging drugmakers to develop more of them. Three years of exclusivity isn't enough of an incentive, the company says.

Patient advocates have another point of view. They've protested Gilead's pricing on Stribild already. If Gilead won that additional two years of exclusivity--and didn't lower its price along the way--then patients would be paying $28,500 per year, for two years longer.

- read the Pharmalot post

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