Gilead Sciences Inc. (GILD) recently announced that it has filed a New Drug Application (NDA) with the US Food and Drug Administration (FDA) seeking approval for its once daily, single tablet, fixed dose combination of Truvada and TMC278 (rilpivirine) as a HIV treatment for adult patients. Gilead conducted a bioequivalence study to support the NDA for Truvada/TMC278.
Truvada is a fixed dose, once daily tablet containing Viread and Emtriva, both manufactured by Gilead, and marketed for the treatment of HIV, while TMC278 has been developed by Tibotec Pharmaceuticals, which is a subsidiary of Johnson & Johnson (JNJ). The candidate is under regulatory review and the company is looking to get TMC278 approved for use in treatment-naïve HIV infected adults.
Gilead entered into an agreement with Tibotec in July 2009 for the development and commercialization of Truvada/TMC278. Gilead is responsible for manufacturing, registration, distribution and commercialization of the combo drug worldwide, excluding Japan.
Tibotec submitted an NDA for TMC278 to the FDA in July. Tibotec’s NDA for TMC278 was supported by positive data from two late-stage trials, ECHO and THRIVE, which studied the safety and efficacy of TMC278 in treatment-naïve HIV patients. In September, Tibotec and Gilead filed the European marketing application for TMC278 and Truvada/TMC278, respectively.
Gilead’s strategy of creating fixed-dose combinations of existing HIV/AIDS drugs has been an enormous success. Apart from Truvada, the company also markets Atripla, which is a combination of Truvada and Bristol-Myers Squibb’s (BMY) Sustiva. Atripla was the major driver of revenue growth in the third quarter of 2010.
Gilead has a deep HIV pipeline, which we believe will contribute significantly to the top line. In addition to Truvada/TMC278, the company is working on the Quad pill, which is a combination of elvitegravir, cobicistat (GS 9350), and Truvada for the treatment of HIV. Quad was found to be more effective than Atripla in a phase II study, according to data released in September 2010.
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