Bristol-Myers Squibb and Gilead Sciences have announced an agreement to commercialise Atripla (efavirenz 600mg/emtricitabine 200mg/tenofovir disoproxil fumarate 300mg) in Europe for the treatment of virologically suppressed adults with HIV-1 infection, subject to the product’s approval by the European Commission.
If approved, Atripla would represent the first and only once-daily single tablet regimen for HIV-1 infection in the EU. The companies expect the European Commission to issue its decision by the end of the year.
Under this agreement, Bristol-Myers Squibb and Gilead share responsibility for commercialising Atripla throughout the EU and certain other European countries. Gilead will record revenues from future net sales of Atripla in most of the European countries, while Bristol-Myers Squibb will record revenues in most of the European countries at percentages relative to the contribution represented by its individual product.
Bristol-Myers Squibb recently concluded an agreement with Merck & Co under which Merck granted Bristol-Myers Squibb rights to co-commercialise Atripla with Gilead in all of the EU and certain other European countries.
Previously, Merck had the exclusive right to market any product containing efavirenz (a component of ATRIPLA) in all European countries other than the UK, Germany, France, Italy, Spain and the Republic of Ireland.
Efavirenz is marketed by Bristol-Myers Squibb under the tradename Sustiva in the USA, Canada and six major countries of the EU.
Efavirenz will continue to be commercialised by Merck & Co through its affiliate Merck Sharp & Dohme (MSD) Limited under the tradename Stocrin in all other countries within the EU and many countries outside of the USA.
Emtricitabine and tenofovir disoproxil fumarate are commercialised by Gilead under the tradenames Emtriva and Viread, respectively, and are commonly prescribed together as a once-daily, fixed-dose tablet, marketed under the tradename Truvada for use as part of combination therapy.
Atripla is currently sold in the USA and Canada through a joint venture between Bristol-Myers Squibb and Gilead. Atripla was approved by the FDA in July 2006 and by Health Canada in October 2007. Gilead and Merck previously announced a collaboration to distribute Atripla in developing countries.