Gilead Sciences ( GILD ) recently
submitted a New Drug Application (NDA) to the US Food and Drug
Administration (FDA) seeking approval to market its hepatitis C
Virus (HCV) candidate sofosbuvir (formerly GS-7977).ARRAY BIOPHARMA (ARRY): Free Stock Analysis
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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
Gilead submitted the NDA on the basis of encouraging data from
four phase III studies (NEUTRINO, FISSION, POSITRON and FUSION).
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.
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 ( JNJ ) and
Bristol-Myers Squibb ( BMY ) are also
developing therapies to combat HCV.
Approval of sofosbuvir would not only bring down the duration of
HCV therapy to 12-16 weeks but also eliminate/reduce the duration
of peg-IFN injections depending on the genotype of the disease.
Currently, HCV therapy includes 24-48 weeks of treatment with
injectable peg-IFN. Moreover, the current standard of care comes
with several side effects which make it difficult for patients to
remain on treatment.
Gilead intends to seek EU approval for sofosbuvir in the second
quarter of 2013. The European Medicines Agency (EMA) has already
granted Gilead's request for accelerated assessment of the
company's Marketing Authorization Application for sofosbuvir. The
acceptance of the request can bring down EMA's review time of the
application by two months. Gilead also intends to seek sofosbuvir
approval in other countries.
Gilead, a biopharmaceutical company, carries a Zacks Rank #2
(Buy). Array BioPharma, Inc. ( ARRY ) is another
favorably placed stock in the biopharma space with a similar