) recently presented encouraging top-line data from a phase III
study (Fusion), which evaluated its candidate sofosbuvir
(formerly GS-7977) combined with ribavirin in patients suffering
from genotypes 2 or 3 of the chronic hepatitis C virus (HCV). The
study evaluated patients who did not respond to prior therapies
for the disease. The patients were evaluated at 12 and 16-week
courses of the candidate. Through this study, Gilead is aiming to
develop an all-oral treatment regimen to combat HCV.
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The phase III study met its primary efficacy objective of
superiority as opposed to a predefined historic control sustained
virologic response rate of 25%. Moreover, sofosbuvir was found to
be safe and well tolerated. None of the patients opted out from
the study due to adverse events.
We note that apart from Fusion, Gilead is evaluating sofosbuvir
in HCV patients in other phase III studies including Positron,
Fission and Neutrino. Gilead intends to seek regulatory approvals
for the candidate in the US and EU, based on data from the
studies, in the second quarter of 2013.
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, which make it difficult for patients continue the
treatment. Apart from Gilead, companies such as Johnson &
) are also developing therapies to combat HCV.
Gilead, a biopharmaceutical company, currently carries a Zacks
Rank #3 (Hold). Biopharma stocks, which are currently well
). Both stocks carry a Zacks Rank #2.