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Gilead Files European Marketing Application for Boosting Agent Cobicistat

Wednesday, May 23, 2012 4:05 PM

Gilead Sciences, Inc. (Nasdaq: GILD) announced today that the Marketing Authorisation Application (MAA) for cobicistat, submitted on April 26, 2012, has been validated by the European Medicines Agency (EMA). Cobicistat is Gilead’s pharmacoenhancing or “boosting” agent that increases blood levels of certain commercially available protease inhibitors, including atazanavir and darunavir, in order to enable once-daily dosing. Currently, ritonavir is the only agent used to boost HIV therapy. Review of the MAA for cobicistat will be conducted under the centralized licensing procedure, which, when finalized, provides one marketing authorization in all 27 member states of the European Union (EU).

“With today’s EMA validation, we’re hopeful that we may soon be able to offer an important new boosting option for patients who rely on protease inhibitors as part of their HIV therapy,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences.

The MAA for cobicistat is supported by pharmacokinetic data demonstrating that cobicistat boosts atazanavir and darunavir exposure similar to ritonavir, and by 48-week data from a pivotal Phase 3 study (Study 114) in which cobicistat met its primary objective of non-inferiority to ritonavir, when both agents were administered with a background regimen of atazanavir plus Truvada® (emtricitabine and tenofovir disoproxil fumarate). Topline results from the study were announced in December 2011, and complete data will be presented at an upcoming medical meeting.

Gilead plans to submit an application for marketing approval of cobicistat to the U.S. Food and Drug Administration (FDA) in the third quarter of 2012. Cobicistat is a component of Gilead’s investigational Quad single tablet regimen, which also contains elvitegravir, emtricitabine and tenofovir disoproxil fumarate. Cobicistat enables once-daily dosing of elvitegravir within the Quad.

In June 2011, Gilead announced an agreement with Janssen R&D Ireland for the development of a fixed-dose combination of cobicistat and darunavir. Subject to regulatory approval, Janssen will be responsible for the formulation, manufacturing, registration, distribution and commercialization of the cobicistat and darunavir fixed-dose combination worldwide. Additionally, in October 2011, Gilead announced an agreement with Bristol-Myers Squibb to develop a fixed-dose combination of cobicistat and atazanavir.


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