Gilead Sciences, Inc.
) recently announced detailed results from four phase III studies
(NEUTRINO, FISSION, POSITRON and FUSION) which evaluated its
candidate sofosbuvir (formerly GS-7977) as a combination therapy
in patients suffering from various genotypes of the chronic
hepatitis C virus (HCV).
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The studies evaluated approximately 1,000 HCV patients. Findings
were published in the New England Journal of Medicine. Gilead
intends to present the data at the 48th annual meeting of the
European Association for the Study of the Liver in the
We note that earlier in the month Gilead had submitted a New Drug
Application (NDA) to the US Food and Drug Administration (FDA)
seeking approval to market sofosbuvir.
Gilead is looking to get the candidate approved in combination
with ribavirin (RBV) as an all-oral therapy for treating patients
affected with genotypes 2 and 3 of the disease. The 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 the basis of data from the NEUTRINO,
FISSION, POSITRON and FUSION studies. Data from the studies
revealed that sofosbuvir-based therapy for 12 or 16 weeks was
either superior or non-inferior to currently available HCV
treatment options. Gilead intends to seek EU approval for
sofosbuvir by Jun 30, 2013.
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 the world over. 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, a biopharmaceutical company, carries a Zacks Rank #3
) appears to be more favorably placed in the biopharma space with
a Zacks Rank #2 (Buy).