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Tibotec licences generic HIV drug

Tibotec Pharmaceuticals, a division of J&J's Janssen-Cilag subsidiary, has granted licenses to several generic manufacturers for its yet-to-be-approved HIV drug rilpivirine

Tibotec Pharmaceuticals, a division of Johnson & Johnson's Janssen-Cilag subsidiary, has granted licenses to several generic manufacturers for its yet-to-be-approved HIV drug rilpivirine (TMC278).

Matrix Laboratories, an Indian subsidiary of the US firm Mylan, and other companies will be permitted to sell low-cost generic versions of the non-nucleoside reverse transcriptase inhibitor in developing counties once the branded version has been approved for marketing.

"By obtaining this licence at this time, we can now begin our research and development phase for our formulation to ensure that a generic version will be available in developing countries as quickly as possible,” said Mylan president Heather Bresch.

Along with the non-exclusive deal it signed with Mylan's Matrix, Tibotec has granted non-exclusive licences 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. "Multiple licences in place for TMC278 with generic manufacturers made before final regulatory approval in the US and Europe underscore the seriousness and speed with which we're working to ensure that all patients in need, not just those in Western markets, will have timely access to the most current regimens," said Will Stephens, vice president of Global Access & Partnerships for Janssen Global Services.

Tibotec has submitted marketing applications for the drug as a treatment of HIV-1 infection in treatment-naive adult patients in combination with other antiretroviral medicines in the US, 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.

28th January 2011

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