Gilead Sciences Inc. (GILD) recently refiled a New Drug Application (NDA) with the US Food and Drug Administration (FDA) for the single-tablet combination of Truvada and TMC-278 (rilpivirine). The company is seeking to get the combination drug approved as a treatment of adult HIV patients.
Gilead’s Truvada is a fixed-dose combination of Viread and Emtriva, marketed as a treatment for HIV, while Johnson & Johnson‘s (JNJ) TMC-278 is a non-nucleoside reverse transcriptase inhibitor. Johnson & Johnson is currently seeking US and European approval for TMC-278 for the treatment of HIV in adults.
Gilead first filed for the approval of the combination pill in November 2010. However, on January 25, 2011, the FDA issued a refuse-to-file notice for the company’s NDA for the once daily, single tablet, fixed dose combination of Truvada and TMC-278 as a treatment of adult HIV patients.
The FDA said in the notification that it is dissatisfied with a particular section of the NDA due to insufficient information and requested additional information on the same.
Following the refiling, the FDA has to conduct a preliminary review within 60 days to establish whether the NDA is complete to permit a substantive review. Thereafter, the regulatory body will set a target action date for the NDA.
Our Take
We currently have a Neutral recommendation on Gilead, which is supported by a Zacks #3 Rank (short-term Hold rating). We believe the combo pill is key to long-term growth at Gilead and in spite of the delay caused due to the FDA’s refuse-to-file notice, the company still expects to launch the drug by the second half of 2011.
Gilead has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval for the combination HIV treatment.
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