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Gilead's triple HIV pill cleared in Europe

Eviplera recommended by EMA for use as a single, once-daily tablet

Gilead Science's HIV therapy Eviplera has been granted approval by the European Medicines Agency (EMA), providing triple therapy in a single, once-daily tablet.

Eviplera is based on Tibotec and Johnson & Johnson's (J&J) non-nucleoside reverse transcriptase inhibitor Edurant (rilpivirine) and Gilead Sciences' market-leading double therapy product Truvada (emtricitabine and tenofovir). It has been approved for use in patients starting antiretroviral therapy for the first time.

J&J's Janssen Pharmaceutica subsidiary said that Edurant has also been approved by the EMA as a single-agent, once-daily tablet for use in combination with other antiretroviral drugs in treatment-naïve HIV patients.

The Eviplera combination therapy was approved by the US Food and Drug Administration (FDA) in August as Complera, when it became only the second fixed-dose triple therapy tablet to reach the market after Gilead, Bristol-Myers Squibb and Merck & Co's Atripla (efavirenz, tenofovir and emtricitabine).

Atripla debuted in 2006 and has revenues of around $3bn a year with its convenience of treatment improving patient compliance.

"As people with HIV are living and remaining on treatment longer, the availability of new simplified therapeutic options has become even more critical," commented Mark Nelson, who heads HIV care at the Chelsea and Westminster Hospital in London, UK.

Eviplera's approval was backed by two studies- ECHO and THRIVE - which compared the efficacy and safety of rilpivirine to efavirenz in treatment-naïve HIV patients, as well as a bioequivalence study which showed that the triple pill achieved blood levels of the active agents comparable to tenofovir, emtricitabine and rilpivirine administered separately.

Under the terms of a 2009 agreement with Tibotec, Gilead will take the lead in manufacturing, registration, distribution and sales of Eviplera in the US, Canada, Brazil, the EU, Australia and New Zealand.

In exchange, Tibotec and partner J&J will be responsible for the commercialisation of rilpivirine as a single agent, with rights to co-detail the single-tablet regimen in these territories.

Gilead is the pharma industry's leader in the HIV market with a share of around 50 per cent, and has also started to expand into other areas. The company is currently in the middle of its acquisition of Pharmasset in an $11bn deal designed to accelerate the development of its hepatitis franchise.

29th November 2011

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