Gilead Sciences (GILD) recently provided an update regarding its chronic hepatitis C virus (:HCV) pipeline.
We note that Gilead had strengthened its HCV pipeline through the purchase of Pharmasset in early 2012. Sofosbuvir was one of the candidates added to Gilead’s pipeline through the acquisition. Gilead is conducting multiple studies with sofosbuvir, a nucleotide analog.
Gilead presented encouraging data from one cohort of the ongoing phase II study (:ELECTRON). The study is evaluating an interferon-free regimen of sofosbuvir, GS-5885 and ribavirin in patients infected with genotype 1 HCV, who had previously not responded to an interferon containing regimen.
Gilead is also evaluating a once-daily fixed-dose combination of sofosbuvir and GS-5885 in multiple studies. The studies (phase II and phase III) are evaluating the combination of sofosbuvir and GS-5885 with and without ribavirin in patients infected with genotype 1 version of HCV.
The studies include ION-1, ION-2 and LONESTAR. The ION-1 phase III study, which commenced in Oct 2012, is evaluating the combination of sofosbuvir and GS-5885 with and without ribavirin (for 12 or 24 weeks) in treatment-naive patients infected with genotype 1 HCV.
The ION-2 phase III study (n=400), expected to commence shortly, will evaluate the fixed-dose combination containing sofosbuvir and GS-5885 with ribavirin for 12 weeks and with and without ribavirin for 24 weeks in treatment-experienced genotype 1 HCV patients.
Gilead intends to seek regulatory approvals for sofosbuvir as a combination therapy in mid-2013 based on data from 4 phase III studies (FISSION, FUSION, POSITRON and NEUTRINO). Moreover, Gilead intends to seek approval of the fixed-dose combination of sofosbuvir and GS-5885 in 2014 on the basis of data from the ION-1, ION-2 and LONESTAR studies.
Successful development of sofosbuvir would not only boost Gilead’s top line but also strengthen its position in the lucrative HCV market. A huge population suffers from HCV infection across the world. However, the treated population is much lower. This leaves the field open for new treatments. Moreover, the current standard of care comes with several side effects.
We currently have a Neutral recommendation on Gilead. The stock carries a Zacks Rank #4 (Sell) in the short run. Pharma stocks, which appear to be favorably placed include Targacept Inc. (TRGT) and Medivation, Inc. (MDVN). Both these companies carry a Zacks Rank #1 (Strong Buy).
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