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Janssen-Cilag Submits HIV Combo

Combines Prezista with Gilead-developed boosting agent

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Janssen-Cilag International, a division of Johnson & Johnson, has submitted a Marketing Authorization Application (MAA) to the EMA seeking approval for a once-daily single tablet fixed-dose antiretroviral combination product containing darunavir (a protease inhibitor developed by Janssen) with cobicistat (a pharmacokinetic enhancer or boosting agent, developed by Gilead Sciences) for use in combination with other human immunodeficiency virus (HIV-1) medicines.

Once-daily darunavir is marketed as Prezista in the EU, and is always taken with and at the same time as ritonavir, a boosting agent, with food and in combination with other HIV medicines.  If approved, the fixed-dose combination tablet will be marketed under a new brand name and will offer a new option that eliminates the need to take a boosting agent in a separate tablet.

In June 2011, Janssen entered a license agreement with Gilead to develop and commercialize this fixed-dose tablet combination product of darunavir and cobicistat. Janssen and its affiliates are responsible for the formulation, manufacturing, registration, distribution and commercialization of the combination worldwide, while Gilead retains sole rights for the manufacture, development and commercialization of cobicistat as a stand-alone product and for use in combination with other agents.

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