Gilead Seeks Approval for Tenofovir Alafenamide for HBV
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Gilead Sciences, Inc. GILD announced that it has submitted a regulatory application to the FDA for once-daily tenofovir alafenamide (TAF) 25 mg for the treatment of adults suffering from chronic hepatitis B virus (HBV) infection. The company also plans to submit a regulatory application for TAF in the EU later this quarter.
Our Take
We note that in the late-stage studies, it was found that TAF, at a dose less than one-tenth of that of Viread, another Gilead drug, showed similar efficacy based on the percentage of patients with HBV DNA levels below 29 IU/mL at 48 weeks of therapy. Meanwhile, the improvements in renal and bone laboratory safety parameters were better in the TAF arm than Viread. Viread generated revenues of $802 million in the first nine month of 2015, up 7.3% year over year. Given TAF’s lower dose, efficacy and safety profile, we believe that TAF has the potential to offer patients an improved treatment option for chronic HBV.
We note that in Nov 2015, Gilead’s first TAF-based HIV drug, Genvoya, was approved by the FDA. Genvoya, the TAF-based single-tablet regimen, comprises TAF, Vitekta (elvitegravir), Tybost (cobicistat) and Emtriva.
Meanwhile, Gilead’s worldwide agreement with Galapagos NV GLPG for the development and commercialization of the JAK1-selective inhibitor, filgotinib, for inflammatory disease indications, including rheumatoid arthritis (RA), is expected to close later this month. The companies plan to initiate phase III studies evaluating the candidate for RA and Crohn’s disease in 2016.
Gilead currently sports a Zacks Rank #1 (Strong Buy). Other top-ranked stocks in the health care sector are Corcept Therapeutics Incorporated CORT and Horizon Pharma plc HZNP, both sporting the same rank as Gilead.