Gilead Files MAA for HIV Drug - Analyst Blog

Gilead Sciences Inc. (GILD) recently announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval for its once daily, single tablet, fixed dose combination of Truvada and TMC278 (rilpivirine) as a HIV treatment for adult patients.

The MAA will first be reviewed by the Committee for Medicinal Products for Human Use (CHMP) and, based on the CHMP’s opinion, the EMA will deliver its decision regarding the approval of the drug.
 
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 is being developed by Tibotec Pharmaceuticals, which is a subsidiary of Johnson & Johnson (JNJ), for treatment-naïve HIV infected adults. Gilead entered into an agreement with Tibotec in July 2009 for the development and commercialization of the once daily, fixed dose combination of Truvada and TMC278.
 
Tibotec submitted a New Drug Application (NDA) for TMC278 to the US Food and Drug Administration (FDA) in July.
 
Gilead’s European application for the fixed dose combination of Truvada and TMC278 is supported by positive data from two late-stage trials. The data from the ECHO and THRIVE trials demonstrated that the fixed dose combination of Truvada and TMC278 had a better safety and tolerability profile than Bristol-Myers Squibb Co.’s (BMY) Sustiva (efavirenz).
 
Neutral on Gilead


We currently have a Neutral recommendation on Gilead, which is supported by a Zacks #3 Rank (short-term Hold rating). We remain optimistic on the growth prospects of HIV drugs, Truvada and Atripla. The company is also looking to increase its presence in the Asian HBV market, where the infection is quite prevalent.

Moreover, we are encouraged by the progress of the company’s pipeline. However, we remain concerned about the price reduction in many European countries and were disappointed to see Gilead cut its fiscal 2010 guidance yet again following the release of second-quarter results.