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
“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.