Back to top

Analyst Blog

Gilead Sciences (GILD - Analyst Report) 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 - Snapshot Report) and Medivation, Inc. (MDVN - Analyst Report). Both these companies carry a Zacks Rank #1 (Strong Buy).

Please login to Zacks.com or register to post a comment.

New to Zacks?

Start Here

Zacks Investment Research

Close

Are you a new Zacks Member or a visitor to Zacks.com?

Top Zacks Features

My Portfolio Tracker

Is it Time to Sell?

One of the most important steps you can take today is to set up your portfolio tracker on Zacks.com. Once you do, you'll be notified of major events affecting your stocks and/or funds with daily email alerts.

More Zacks Resources

Zacks Rank Home - Evaluate your stocks and use the Zacks Rank to eliminate the losers and keep the winners.

Mutual Fund Rank Home - Evaluate your funds with the Mutual Fund Rank for both your personal and retirement funds.

Stock/Mutual Fund Screening - Find better stocks and mutual funds. The ones most likely to beat the market and provide a positive return.

My Portfolio - Track your Portfolio and find out where your stocks/mutual funds stack up with the Zacks Rank.

Zacks #1 Rank Top Movers for Zacks #1 Rank Top Movers

Company Symbol Price %Chg
RPC INC RES 24.91 +8.35%
LITHIA MOTO… LAD 94.59 +4.60%
DELTA AIR L… DAL 39.15 +3.90%
FLAMEL TECH… FLML 14.51 +3.50%
SOUTHWEST A… LUV 28.87 +2.92%