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GSK Acquires PRV for ViiV’s Two-Drug HIV Therapy, Beating Gilead to Billion-Dollar Market

Late last week, ViiV Healthcare filed applications with both the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) for the world’s first two-drug HIV maintenance therapy. The treatment will also be the first of its kind on the market thanks to a surprising priority review voucher (PRV) acquisition by ViiV’s majority owner, GlaxoSmithKline – capitalizing on the multi-billion-dollar HIV market four months earlier than competitors Gilead‘s HIV treatment.

Instead of the usual 10-month application process, this PRV allows ViiV, and therefore GSK, to have it completed in six months. For more information on PRVs, check out our 2nd Annual Priority Review Voucher Summit website right now!

According to Endpoints News’ John Carrol, ViiV’s breakthrough therapy combines dolutegravir (aka Tivicay) and rilpivirine (aka Johnson & Johnson’s Edurant). ViiV (which is also backed by Pfizer and Japan’s Shionogi) revealed GSK acquired the PRV for $130 million, though from whom they got the PRV is still a mystery.

“As people living with HIV plan their lives, there is a need for new options to best manage their lifelong treatment,” ViiV chief executive Deborah Waterhouse said in a statement, according to the Telegraph. “At ViiV Healthcare, we are not only developing potential new medicines to treat and prevent HIV infection; we are challenging the traditional HIV treatment paradigm to develop new treatment regimens.”

This news is adding insult to injury for Gilead. The pharmaceutical giant’s own HIV drug, bictegravir, didn’t surpass any drugs already on the market, according to data released earlier last week. Ongoing research and approval applications kept hope alive for Gilead, but for only a handful of days. Read more on this news over at FiercePharma.

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