Gilead Sciences Inc.
) recently announced that its Marketing Authorisation Application
(MAA) for HCV candidate sofosbuvir (formerly GS-7977), submitted
to the European Medicines Agency (EMA) on Apr 17, 2013, has been
validated and is under review.
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 MAA 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.
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Gilead submitted the MAA 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.
The EMA granted Gilead's request for accelerated assessment of
the company's Marketing Authorization Application for sofosbuvir.
The acceptance of the request is expected to bring down EMA's
review time of the application by two months. Gilead also intends
to seek sofosbuvir approval in other countries. Gilead expects
sofosbuvir to be available in the EU by the first half of 2014,
assuming approval. Gilead is also seeking US approval for
Approval of sofosbuvir would bring down the duration of HCV
therapy to 12-16 weeks. 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.
Approval of sofosbuvir would not only boost Gilead's top line but
would also strengthen its position in the lucrative HCV market. A
sizeable population suffers from HCV throughout the world.
However, the treated population is much lower. This leaves the
field open for new treatments. We note that companies such as
Johnson & Johnson
) are also developing therapies to combat HCV.
Gilead, a biopharmaceutical company, carries a Zacks Rank #3
) appears to be more attractive in the biopharma space with a
Zacks Rank #2 (Buy).