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Tibotec HIV drug approved

The US Food and Drug Administration has approved Tibotec Therapeutics' HIV drug Edurant for use in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults

The US Food and Drug Administration has approved Tibotec Therapeutics' HIV drug Edurant (rilpivirine) for use in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults who have never been treated with any other HIV therapy.

Edurant, a non-nucleoside reverse transcriptase inhibitor (NNRTI), has been cleared for use as part of a highly active antiretroviral therapy (HAART) regimen. It is a once-daily pill that must be taken with food.

The approval was based in part on 48-week data from two phase III clinical trials that enroled a total of 1,368 adult subjects with HIV infection, as well as one 96-week study that was extended to 192 weeks. The phase III programme compared Edurant to Bristol-Myer Squibb's NNRTI Sustiva (efavirenz), with both products administered in combination with other antiretroviral drugs.

The results showed that Edurant was as effective as Sustiva in lowering viral load, with 83 per cent of Edurant subjects and 80 per cent of Sustiva subjects having undetectable amounts of HIV in their blood after 48 weeks of treatment. However, patients who failed therapy with Edurant developed more drug resistance than patients who failed efavirenz.

Tibotec, a division of J&J's Centocor Ortho Biotech, announced last year that it had granted licenses to several generic manufacturers for Endurant, even before the drug had been approved.

Under the deals, Matrix Laboratories, an Indian subsidiary of the US firm Mylan, and other companies will be permitted to sell low-cost generic versions of the product in developing counties. Along with a non-exclusive deal it signed with Mylan's Matrix, Tibotec granted non-exclusive licenses to international generic manufacturers including India's Hetero Drugs Limited and South Africa's Aspen Pharmacare allowing them to manufacture, market and distribute the generic drug.

Matrix and Hetero will have the rights to market the product in sub-Saharan Africa, certain developing countries and India, while Aspen will have rights to market the product in sub-Saharan Africa including South Africa.

Tibotec said it has chosen to work with multiple manufacturers to ensure widespread and sustainable access to the drug in poor areas with a high disease burden.

Tibotec has submitted marketing applications for the branded drug in Europe, Canada, Switzerland, Australia, Russia and South Korea. The generic manufacturers, who will pay Tibotec low single-digit royalties on sales, are responsible for filing the generic drug applications.

Tibotec noted that it is working toward separate agreements in order to ensure that low-cost versions of a fixed-dose combination of rilpivirine and Gilead Sciences' Truvada (emtricitabine and tenofovir disoproxil fumarate) are made available in developing countries. Tibotec and Gilead entered into a collaboration for the once-daily, fixed-dose combination product in 2009.

23rd May 2011

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