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Priority Review for Gilead Drug

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Gilead Sciences, Inc. (GILD - Free Report) recently announced that its candidate sofosbuvir (formerly GS-7977) being developed for treating patients suffering from chronic hepatitis C virus (HCV), has been granted priority review status by the US Food and Drug Administration (FDA).

Gilead is looking to get the candidate approved in combination with ribavirin as an all-oral therapy for treating patients affected with genotypes 2 and 3 of HCV. The New Drug Application (NDA) also includes data backing the use of sofosbuvir in combination with RBV and pegylated interferon (peg-IFN) as a first-line therapy in patients suffering from the genotypes 1, 4, 5 and 6 of the virus.

Gilead submitted the NDA on Apr 8, 2013 based on encouraging data from four phase III studies (NEUTRINO, FISSION, POSITRON and FUSION).

The FDA reviews applications for priority review designated drugs within eight months of submission as against the usual 12 months. Consequently, a decision from the FDA is expected by Dec 8, 2013. We note that the US regulatory authority generally reviews those drugs, which offer major advances in treating diseases over existing therapies, on a priority basis. Sofosbuvir is also under review in the EU.

Approval of sofosbuvir would not only boost Gilead’s top line but also strengthen its position in the lucrative HCV market. A sizeable population suffers from HCV globally. However, the treated population is much lower. This leaves the field open for new treatments. We note that companies such as Johnson & Johnson (JNJ - Free Report) and Bristol-Myers Squibb Company (BMY - Free Report) are also developing therapies to combat HCV.

Gilead carries a Zacks Rank #3 (Hold). Anika Therapeutics, Inc. (ANIK - Free Report) appears to be more favorably placed with a Zacks Rank #1 (Strong Buy).

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