The world’s biggest HIV drug maker, Gilead Sciences, Inc. (GILD - Analyst Report) received a huge boost following approval by the US Food and Drug Administration (FDA) for its once-daily single tablet regimen (STR) for the treatment of HIV in previously untreated adults. The tablet, which will be marketed as Complera, is a combination of Gilead’s most popular HIV drug, Truvada (a fixed-dose, once-daily tablet containing Gilead's Viread and Emtriva), and Johnson and Johnson’s (JNJ - Analyst Report) recently approved HIV drug Edurant. Complera is the second STR approved for the treatment of HIV, the first being Atripla, which is marketed by Gilead and Bristol Myers Squibb (BMY). Gilead is also seeking approval for the combo pill in Europe.
Gilead has a license and collaboration agreement with Tibotec Pharmaceuticals (a subsidiary of Johnson & Johnson) for the development and commercialization of Complera. Gilead will be responsible for manufacturing, registration, distribution and commercialization of Complera in the US, European Union, Canada, Brazil, Australia and New Zealand. Johnson and Johnson can co-market the drugs in these territories. The agreement has been expanded to include certain European countries, Latin America and the Caribbean. Johnson and Johnson will be responsible for other territories, particularly Asia Pacific, including Japan, the Middle East, Eastern Europe and all of Africa.
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