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UPDATE 1-GSK wins priority status for new HIV drug in U.S.

Fri, 15th Feb 2013 16:08

LONDON, Feb 15 (Reuters) - U.S. regulators gave priorityreview status to an experimental GlaxoSmithKline drugfor HIV/AIDS, which industry analysts view as a possiblemultibillion-dollar-a-year seller.

The U.S. Food and Drug Administration awards certain drugspriority status when they have the potential to offersignificant improvement over existing treatments.

The agency is due to give its verdict on whether to approvedolutegravir by Aug. 17, Britain's biggest drugmaker said onFriday.

The once-daily drug, which belongs to a novel class known asintegrase inhibitors that block the virus causing AIDS fromentering cells, is owned by ViiV Healthcare, a joint venturefocused on HIV in which GSK is the largest shareholder.

The new medicine has already performed strongly in clinicaltrials, prompting GSK to raise its bet on the product lastOctober by redrawing a deal with Japan's Shionogi.

Under that agreement Shionogi agreed to take a 10 percentstake in Viiv - which was set up in 2009 between GSK and Pfizer - in exchange for its shared rights to dolutegravir.

The agreement left GSK holding 76.5 percent of ViiV, withPfizer controlling 13.5 percent and Shionogi the remainder.

Analysts see dolutegravir as a strong competitor to HIVtreatments from market leader Gilead Sciences.

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