The application was filed jointly by the three companies through a newly established three-way joint venture based in Ireland. Discussions among the three companies regarding agreements for manufacturing, commercialization and distribution of Atripla in the European Union are ongoing.
Atripla is a once-daily single tablet regimen approved in the US for the treatment of HIV-1 infection in adults for use either as stand- alone therapy or in combination with other antiretroviral agents.
Atripla has already been approved by the FDA. The FDA also granted approval of an alternate tradedress of Atripla for developing countries, where Atripla will be made available as a white-colored tablet to distinguish it from the salmon-colored version currently available in the US. Gilead and Merck established a separate agreement in August 2006 for distribution of the product in developing countries.
“As the first and only once-daily single tablet regimen, Atripla may help to simplify therapy for many HIV-infected adults,” said Kevin Young, executive vice president, Commercial Operations, Gilead Sciences.