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UPDATE 2-Gilead and GSK drugs for HCV and HIV win EU green light

Fri, 22nd Nov 2013 16:36

* EMA recommends Gilead's Sovaldi and GSK's Tivicay

* Also backs Otsuka TB drug, Bristol/Astra diabetes pill

* Gilead shares rise 4.7 percent

LONDON, Nov 22 (Reuters) - European regulators haverecommended approval of a new drug from Gilead Sciences to treat hepatitis C and an HIV medicine from GlaxoSmithKline, both of which are expected to be major sellers.

The European Medicine Agency (EMA) said on Friday itscommittee of experts also gave the green light to a tuberculosisdrug from Japan's Otsuka, following a review of anearlier rejection.

Recommendations for marketing approval by the EMA'sCommittee for Medicinal Products for Human Use (CHMP) arenormally endorsed by the European Commission within a couple ofmonths.

Analysts expect U.S.-based Gilead's sales to surge highernext year on the back of its treatment known as Sovaldi, orsofosbuvir, for people infected with the liver-destroyinghepatitis C virus (HCV). The all-tablet treatment obviates theneed for the injectable drug interferon, which can causedebilitating side effects.

Investors see the treatment as the crown jewel of Gilead's$11 billion purchase of biotechnology company Pharmasset and themarket is expecting substantial revenues.

Shares in Gilead were up 4.4 percent at 1632 GMT followingnews of the European recommendation.

Analysts on average expect Gilead's drug to generate salesof $4.4 billion in 2015, according to Thomson Reuters Pharma.

The often-undiagnosed hepatitis C virus is transmittedthrough contaminated blood. While infection rates have droppedsince the early 1990s - due in part to the introduction of bloodand organ screening - many older adults remain at risk.

Two new antiviral drugs, Incivek from Vertex Pharmaceuticals and Victrelis from Merck & Co, have cured moreHCV patients in recent years, but both are protease inhibitorsand are still used in combination with injections.

Sovaldi was recommended by an expert advisory committee ofthe U.S. Food and Drug Administration last month and a finaldecision from the FDA is expected by Dec. 8.

GSK's Tivicay, or dolutegravir, is also forecast to be asignificant new product for the British drugmaker. It will besold through the ViiV Healthcare business, in which GSK is thebiggest shareholder, alongside Pfizer and Shionogi.

The once-daily drug belongs to a novel class known asintegrase inhibitors that block the HIV virus from enteringcells, and is designed to be used in combination with other HIVdrugs. Consensus forecasts point to sales of $1.6 billion by2018. GSK shares were up 0.18 percent.

In addition, the European agency recommended approval of anew two-in-one diabetes drug called Xigduo from Bristol-MyersSquibb and AstraZeneca.

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