Gilead Sciences, Inc.
) 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).
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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
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
Bristol-Myers Squibb Company
) are also developing therapies to combat HCV.
Gilead carries a Zacks Rank #3 (Hold).
Anika Therapeutics, Inc.
) appears to be more favorably placed with a Zacks Rank #1